Unlocking Efficiency and Expertise: The Strategic Value of Fractional Service Providers in Drug Development and Medical Affairs

Executive Summary

In today’s dynamic and capital-constrained biotech environment, early-stage companies must balance scientific innovation with lean operations. Leveraging fractional service providers (FSPs)—highly experienced professionals or firms that provide part-time, on-demand support—has become an increasingly popular and effective strategy. This white paper outlines the strategic advantages of using FSPs in drug development and medical affairs, including cost savings, access to Subject Matter Experts (SMEs), scalability, and accelerated timelines.

Introduction

Drug development is inherently complex and resource-intensive, requiring coordinated, cross-functional expertise across multiple domains – including regulatory science, clinical operations, pharmacovigilance, Health Economics and Outcomes Research (HEOR), manufacturing, medical affairs, scientific communications, and field-based medical liaisons. Similarly, medical affairs plays a vital role in bridging scientific knowledge and stakeholder engagement. However, building full-time internal teams for each function is often impractical for startups and small biotech firms. Fractional service providers offer a flexible, high-impact alternative.

Key Benefits of Fractional Service Providers

1. Cost Efficiency Without Compromising Quality

• Reduced Overhead: Eliminate long-term employment costs, benefits, and infrastructure burdens. For many small companies developing a single investigational product, hiring a full-time expert may be unnecessary and inefficient—both financially and operationally. Moreover, top-tier professionals may be disinclined to accept full-time roles that lack sufficient workload or long-term engagement.

• Predictable Budgeting: FSPs typically work on defined scopes or hourly retainers, allowing tighter financial control.

• High Value: Gain access to SMEs with industry experience that would be cost-prohibitive to hire full-time.

2. Access to Senior-Level Expertise

• FSPs can bring decades of experience from large biopharma, regulatory agencies, and successful startups.

• Strategic Insights

• Preclinical planning and execution

• Regulatory strategy and submissions

• Clinical operations

• Reimbursement execution (Health Economics and Outcomes Research)

• Payer Value Proposition

• Economic models

• Pre-approval communication and negotiation with Health Technology Assessment (HTA) bodies

• While Quality of Life (QoL) metrics are rarely the primary drivers of reimbursement decisions, patient-reported outcomes (PROs) collected during clinical trials play a crucial role. These data inform long-term cost-effectiveness and utility models and are frequently evaluated by Health Technology Assessment (HTA) bodies to guide pricing and market access decisions.

• Payer Value Dossier

• Real-World Evidence (RWE) planning, execution and scientific communication

• Post-approval studies to inform and secure payer contractual agreements

3. Speed and Agility

• Rapid onboarding of fractional experts accelerates early-stage milestones.

• FSPs are project-focused and delivery-oriented, enabling faster document turnaround, strategic decisions, and agency responses.

• Minimizes internal delays caused by hiring gaps or capability bottlenecks.

4. Scalable Support Across Development Milestones

• Support can evolve across the product lifecycle:

• Preclinical/IND: Regulatory planning, toxicology review, Chemistry, Manufacturing, and Controls (CMC) input, and RWE to inform clinical trial design.

• Clinical Phase I–III: Protocol development (including incorporation of patient reported outcomes), medical monitoring, Data and Safety Monitoring Board (DSMB) engagement and RWE (market mapping, burden/cost of illness studies to support unmet medical need and inform economic models.

• Post-Approval: RWE generation, scientific publications, launch support.

• The ability to increase or reduce engagement based on funding cycles or pipeline progress.

5. Strategic Partnership Without Organizational Bloat

• FSPs often act as embedded team members while maintaining independent objectivity.

• Allows startups to "punch above their weight" in meetings with FDA, European Medicines Agency (EMA), payers, and investors.

• Fosters knowledge transfer and capacity building for in-house teams.

  Use Cases in Drug Development and Medical Affairs

Phase and Example FSP Roles:

Pre-IND: Regulatory strategist, preclinical toxicologist, CMC advisor, epidemiologist

Phase I/II: Medical monitor, clinical operations advisor, statistician, protocol medical writer, HEOR consultant

Phase III: Safety surveillance, medical publication professional, payer strategist, HEOR consultant, epidemiologist

Post-Approval: HEOR consultant, medical science liaison trainer, advisory board moderator, epidemiologist

Real-World Example

A virtual oncology biotech engaged a fractional Chief Medical Officer (fCMO) and medical monitor from MedSurgPI. Over six months, they:

• Finalized an IND with FDA-ready protocols,

• Set up medical review procedures for a First in Human (FIH) trial,

• Initiated early scientific engagement with KOLs across US and EU.

The company saved over $500,000 compared to hiring a full-time team and moved from candidate nomination to IND submission in just nine months.

Conclusion

Fractional service providers are not just a stopgap—they are a strategic solution for modern drug developers seeking flexibility, efficiency, and deep expertise without the cost and complexity of traditional hiring. Especially in medical affairs and development functions, FSPs offer a high-value way to accelerate innovation while maintaining lean operations.

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About MedSurgPI                                              

MedSurgPI provides fractional medical monitoring, regulatory, and medical affairs to biotech and medtech innovators. Our network of seasoned professionals supports companies from preclinical planning through to market launch.

 info@medsurgpi.com

About Star Biopharma Consulting

Star Biopharma Consulting provides fractional support for HEOR consultants, epidemiologists, medical directors, economists, data scientists, and medical writers. Our specialties include Real-world Evidence Generation, Economic Modeling, Evidence Synthesis, Scientific Communications, Post-Authorization Commitments, Patient-focused Research, HTA Preparedness, and Market Access Support.

 📧 info@starbiopharmaconsulting.com

🌐 www.starbiopharmaconsulting.com

Pre-Clinical Checklist for IND Submissions

Before your initial submission with the FDA,

check with us

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        Pre-Clinical Checklist for IND Submission

General Planning

·         Proposed Route of Administration

·         Target Indication

·         Define drug development goals and regulatory strategy

·         Determine target indication(s)

·         Identify the regulatory pathway (e.g., 505(b)(1), 505(b)(2))

·         Confirm if a Pre-IND meeting is needed

·         Develop a list of specific questions for FDA (clinical, CMC, nonclinical)

·         Prepare timeline for IND-enabling activities

Drug Substance & Product (CMC – Chemistry, Manufacturing, and Controls)

·         Proposed Route of Administration

·         Target Indication

·         Stability Studies

·         Drug substance information (source, synthesis, characterization)

·         Drug product formulation details

·         Manufacturing process description and controls

·         Stability data and proposed storage conditions

·         Analytical method development and validation

·         Packaging and labeling overview

Nonclinical/Preclinical Studies

·         Proposed Route of Administration

·         Target Indication

·         Stability Studies

·         Summary of completed pharmacology/toxicology studies

·         Summary of ongoing or planned IND-enabling toxicology studies

·         Justification for proposed first-in-human (FIH) dose

·         Species selection rationale and relevance to humans

·         GLP compliance documentation (if available)

Clinical Plan

·         Proposed Route of Administration

·         Target Indication

·         Stability Studies

·         Draft protocol for Phase 1 study (or Phase 0, if applicable)

·         Clinical trial objectives and design

·         Inclusion/exclusion criteria

·         Safety monitoring plan

·         Risk mitigation strategies

·         Informed consent process summary

Regulatory Documentation

·         Proposed Route of Administration

·         Target Indication

·         Stability Studies

·         Request for Pre-IND meeting (if applicable)

·         Proposed questions for the FDA

·         Pre-IND briefing document draft

·         Investigator’s Brochure (if available)

·         IND application planning and structure (Module 1-5 format)

·         Review of relevant guidance documents

Operational Readiness

·         Identify CROs, CMOs, and other partners

·         Develop timelines and resource plans

·         Ensure team roles and responsibilities are defined

·         Intellectual property status reviewed

·         Regulatory consulting company

·         Pre-clinical animal testing facility

Latin America as Part of Rare Disease and Oncology Drug Development

Contributors: Sara Tylosky, CEO/Farmacon Global; Luis Squiquera, MD, CMO/Farmacon Global; Gerald L. Klein, MD, Principal at MedSurgPI, LLC and Roger E. Morgan, MD, Vice President, Medical Affairs at MedSurgPI, LLC

Introduction

Rare disease and oncology research represent some of the most challenging yet rewarding areas in clinical development. With over 700 rare disease therapies in development and thousands of oncology trials underway globally, the race to bring innovative treatments to patients is intensifying. Despite these advances, drug and treatment development in these fields face significant obstacles, ranging from protocol design to patient recruitment. This paper examines these challenges and offers strategic solutions for investors and biotech companies aiming to accelerate clinical trial success and reduce development costs.

Challenges in Rare Disease and Oncology Drug Development

Developing Practical Protocols with Robust Statistical Support

Protocols for rare disease and oncology trials must balance scientific rigor with real-world feasibility. Rare disease trials, in particular, face the challenge of small patient populations, complicating statistical power and endpoint selection. These constraints necessitate advanced statistical methodologies, such as linkage analysis, transmission disequilibrium tests, and rare-variant association studies, supported by cost-effective sequencing and genotyping platforms. Additionally, national-scale electronic health records (EHRs) provide invaluable data for estimating prevalence and clinical characteristics (Abdala, 2023). 

Streamlining Inclusion and Exclusion Criteria

Overly complex or restrictive eligibility criteria can hinder patient recruitment and trial efficiency. Pragmatic, well-defined inclusion and exclusion steps are essential for maintaining regulatory compliance while ensuring a broad patient participation.

Engaging Key Opinion Leaders (KOLs)

Involving experienced KOLs enhances protocol design and ensures clinical applicability. We have identified and engaged key Latin American KOLs so that we save significant time and resources in selecting clinical sites. 

Selecting Optimal Trial Sites

Choosing trial sites with limited patient pools or inadequate infrastructure can lead to costly delays. Our unique expertise and strong relationships enable strategic site selection, guided by demographic and epidemiological data, to drive trial success.

Partnering with Patient Advocacy Groups (PAGs)

PAGs play a critical role in connecting researchers with patient communities, enhancing recruitment and retention. Building effective partnerships requires significant time and effort to establish culturally sensitive relationships and these dedicated resources.

Ensuring Quality and Compliance Among Principal Investigators (PIs)

Quality regulatory compliance is vital for trial integrity. PIs must be well-versed in Good Clinical Practice (GCP) guidelines to mitigate risks and enhance data reliability. This necessitates a collaborative partnership and ongoing quality improvement with trial sites to uphold data integrity and ensure the highest standards of excellence.

Comprehensive Training for Trial Staff

We ensure comprehensive training to decrease the potential of protocol deviations and data integrity concerns, including audit preparation for sites. Standardized training programs ensure consistency and adherence to best practices.

Solutions for Success in Rare Disease and Oncology Trials

Strategic Regulatory Support

Engaging experienced regulatory teams facilitates navigation through complex global frameworks, ensuring adherence to stringent approval processes.

Expanding Trials into Emerging Markets

Latin America has become a key destination for clinical trials due to multiple advantages:

●        Large Treatment-Naïve Population:  With a population of 664 million, the region offers a substantial pool of treatment-naïve patients who may meet eligibility requirements for oncology and rare disease studies.

●        Cost Advantage:  Clinical trials in Latin American can be 30-40% less expensive than those conducted in the U.S. or Europe, making it a financially viable option.

●        Availability of Experienced Investigators and High-Quality Research Sites: Rather than focusing solely on real-world data, Latin America benefits from a strong network of experienced principal investigators and high-quality research sites capable of efficiently conducting trials.

●        Lower Competition for Clinical Trials: Unlike North America and Europe, Latin America has fewer competitive trials, allowing for faster patient recruitment and higher enrollment rates.

●        Diverse Representation:  The region’s diverse ethnic mix has a significant Latino/Hispanic population, and in places like Brazil and Colombia also includes African descent, which enhances inclusivity and representativeness in clinical trials.

●        Regulatory Expertise: Regulatory timelines have significantly improved in Brazil, Mexico, and Argentina. With our expert guidance, we ensure a seamless and efficient regulatory approval and drug importation process, helping you stay on track and accelerate your clinical trial progress.

Collaborating with Leading Experts

Engaging KOLs in rare diseases and oncology helps refine protocol design and improve recruitment strategies. Early expert involvement ensures trials align with real-world patient needs and regulatory expectations.

Comprehensive Training Initiatives

Providing targeted training for PIs, site staff, and monitors enhances protocol adherence and regulatory compliance, reducing risks and optimizing efficiency.

Optimized Site Selection

Leveraging local expertise and networks in Latin America allows sponsors to identify sites with strong infrastructure and access to large patient populations.

Strengthening Partnerships with PAGs

Collaborating with PAGs ensures patient-centric trials, boosting recruitment and retention while refining research methodologies based on patient experiences.

Conclusion

Rare disease and oncology clinical trials are essential for advancing medical innovation. However, these trials require tailored strategies to overcome challenges related to protocol design, patient recruitment, and regulatory compliance. By leveraging emerging markets, engaging key experts, and fostering strong patient advocacy partnerships, biotechs and investors can reduce costs, accelerate timelines, and enhance trial outcomes.

MedSurgPI, LLC offers expert fractional Chief Medical Officers worldwide, providing strategic medical consulting in development, safety, and medical monitoring. www.medsurgpi.com.

Farmacon Global provides integrated solutions to navigate these complexities. From optimizing site selection and regulatory strategies to engaging stakeholders and advocacy groups, our expertise empowers clinical research teams to advance breakthrough treatments efficiently.

References

bioaccess®. Why Latin America demographics benefit clinical trials. Retrieved from https://www.bioaccessla.com/blog/why-latam-demographics-benefit-clinical-trials.

Abdala, M. July 2023. Strategies to achieve greater competitiveness for clinical trials in Latin America. DIA Global Forum. Retrieved fromhttps://globalforum.diaglobal.org/issue/july-2023/strategies-to-achieve-greater-competitiveness-for-clinical-trials-in-latin-america/

An Introduction to Preclinical Pharmacology: A Mesa Science and MedSurgPI White Paper

Preclinical Studies Required for Obtaining FDA IND Approval

Authors from Mesa Science Associates: Kaitlyn Wylie, Kenneth Dretchen

Authors from MedSurgPI: Gerald Klein, Roger Morgan, Lee Schacter, Freddy Byrd, Devsmita Das

Introduction

The FDA issuance of an Investigational New Drug (IND) application is dependent upon the successful completion of multiple preclinical studies including both pharmacology and toxicology evaluations. These studies consist of pharmacodynamic, pharmacokinetic, and toxicology studies that should be completed prior to submission and other additional required studies after initial FDA discussions. 

Pharmacology 

·         Pharmacodynamics

Pharmacodynamic studies  are investigations that describe and confirm the basic mechanism of action of a new drug candidate.  These involve either or both in vivo or in vitro experiments. It is essential that the physiological response generated by the chemical entity can be measured with high precision and remains stable during the course of the experiment in in vivo studies.  This includes heart rate, blood pressure, cardiac contractility, respiration rate, tidal volume, gastrointestinal motility, skeletal muscle contracture and urinary outflow.  A dose/response or a dose/escalation study which measures the quantity of the drug received versus the initiated response should be undertaken. For example, an agonist will produce a standard S-shaped curve when comparing increasing doses to increasing responses including a threshold point, a rising phase, and a celling.

The other graphical evaluation that is useful in determining the duration of action is referred to as a time-action curve that compares the response obtained over time following the administration of a fixed dose of a drug. Increasing doses of the drug should generate parallel curves until the maximum response is obtained. Additional information that can be obtained are an estimate of the duration of the drug and inferences regarding any overt adverse events. 

If at all possible, in vitro confirmation of the site and mechanism of action would be invaluable (Moctezuma-Ramirez et. al 2023). 

·         Pharmacokinetics (PK)

These experiments characterize the absorption, distribution, metabolism, and excretion (ADME) of the chemical entity. The administration of the drug in these experiments should mimic the intended route for human use. Since most drugs are either weak acids or weak bases, the PK is critically important to determine the degree of ionization which contributes to the drug’s ability to cross lipid membranes. Orally administrated drugs that are acidic would be preferentially absorbed in the stomach whereas those drugs that are basic would be preferentially absorbed in the small intestine. When considering the parenteral administration of drugs, it is imperative to use the correct length/caliber of needle to ensure the drug is in the intended compartment.  Regarding a drug’s distribution, calculating the Volume of Distribution (VD) will indicate if the drug is confined to the plasma, the extracellular space, or the intracellular space (total body of water). Most drugs are metabolized in the liver by first order elimination kinetics. An estimate of metabolism can be obtained by calculating the Elimination Constant (Ke). 

The gold standard of pharmacokinetic testing is the administration of a fixed dose of a drug and the measurements of the resultant plasma levels. The three critical parameters are the Maximum Concentration (Cmax), Time to Maximum Concentration (Tmax) and Area Under the Curve (AUC), which allows assessment of the amount of drug delivered to the bloodstream over time. The graphical representation of the plasma levels over time allows for the calculation of the half-life (T1/2). If a drug is administered by any route other than intravenously, the Bioavailability (F) should be calculated. Bioavailability assesses how much of an orally administered drug is absorbed into the blood. This is defined as the AUC obtained by the intended route of administration (typically oral), divided by AUC of the intravenously administered drug. This is also essential for topical drugs, to determine if significant amounts of the drug reach the systemic circulation and depends on whether the drug was intended for local use, or systemic effects. 

Toxicology 

These experiments are designed to evaluate higher doses of the drug in order to determine the incidence of adverse side effects. One of the most important of these tests is the No Observed Adverse Effects Level (NOAEL) which represents the highest dose prior to the appearance of an adverse effect. The safety of a drug can also be obtained by calculating the Therapeutic Index (TI). This is the ratio of the dose that is lethal to fifty percent of animals tested (LD50), divided by the dose that is effective in fifty percent of the animals (ED50). It should be noted that standard toxicology testing involves both histologic and pathologic examination of all organ systems.

It is recommended that in preparation for the initial meeting with the FDA a dose range finding study in two animal species should be conducted, one in a rodent model and the other in a larger animal species with the drug administered in the intended route of administration. Evaluations which will include clinical pathology, ocular examinations, EKG, toxicokinetic assessments, necropsy and histopathology. A toxicokinetic evaluation (similar to a pharmacokinetic study) should be conducted. Clinical pathology should include hematology, coagulation, clinical chemistry assessment and urinalysis in addition to histopathology. The duration of the study will be dependent on whether the drug is intended for a single or multiple dose administration. Another required test is the AMES study which employs a bacterial reverse mutation assay, to assess the potential of a chemical to cause DNA mutations. Another recommended test is the in vitro micronucleus assay in TK6 cells which is used to evaluate the genotoxicity of the chemical agent. The hERG study is also used to monitor dysfunction of potassium channels which could lead to prolongation of the QT segment on EKG, which can result in sudden death from arrhythmia. 

Additional studies will be required following the initial meeting with FDA. These consist of  toxicity screening in two species of animals, , conducted under Good Laboratory Practice (GLP) conditions using Good Manufacturing Practice (GMP) grade material of the drug substance. Conducting studies by GLP/GMP international standards requires a higher level of quality control than other studies. These studies will be of a longer duration than those previously described.  In addition, studies will be required to assess the safety of the drug on the cardiovascular, respiratory and central nervous system. 

Ensuring a Successful Study Outcome  

·         Protocol

One of the most important aspects is the generation of a comprehensive protocol prior to beginning the study. It is critical that the hypothesis is clear and that the experiments are sufficiently designed to either prove or disprove the hypothesis (Huang, W., et. 2020). No detail should be overlooked, including every component of a drug solution. All details such as the ambient temperature, humidity and lighting need to be recorded. 

·         Animal Model

The animal models selected for the study should be based upon the known comparability of the physiologic responses to the effects observed in humans. For example, studies evaluating the cardiovascular system are often done using pigs since the cardiac anatomy and physiology is comparable to humans (Moctezuma-Ramirez et. al 2023). Although rodents are predominantly used for initial screening of new drugs, there are large differences in the physiology of many organ systems between the two species. 

·         Animal Housing and Welfare

A high degree of non-reproducibility of experimental results between two different laboratories can often be attributed to differences in animal housing and the handling of the animals during acclimation prior to conducting the experiments. The quality of the animal care and use program and in life portion of the study contributes in large measure to the overall quality of an animal experiment (Everitt 2015). From the time of the animal’s arrival at the facility, actions must be put in place to properly prepare the animal for the study during this time, that animal’s baseline vitals and general condition can be assessed (Moctezuma-Ramirez et. al 2023). 

·         Statistical analysis

A critical aspect is the adequacy of the sample size (Lazic et. al 2018). The use of an inadequate number of animals might fail to detect a significant difference due to factors such as minimizing animal to animal variability (Bonapersona et al., 2019; Carneiro et al., 2018; Howells et al., 2014). It is often advisable to calculate power and sample size which is based upon known variability and  probability. One way to increase external validity is to conduct identical studies at multiple sites, emulating an approach already applied in clinical trials (Dechartres et al., 2011; Friedman et al., 2015). Randomization and blinding should also be used in the allocation and administration, respectively, of the new treatment in order to reduce bias in the study and increase the validity of the results (Aban and George 2015). Most of these studies involve administering both drug and placebo to animals, so one may determine what the background incidence of findings are in untreated animals. 

·         GMP Drug Substance and GLP Requirements

It is acceptable to use non-GMP grade material under non-GLP conditions for the initial experiments that confirm the site and mechanism of action as well as the preliminary dose-response and ADME (absorption, distribution, metabolism, and excretion) experiments.  However, all of the pharmacokinetic experiments that calculate the Cmax, Tmax and AUC should be done under GLP conditions. The requirements of a GLP study are much more rigorous than those of non-validated exploratory studies because in GLP studies, the researchers are held accountable for the reliability, reproducibility, and validity of their study techniques, quality control features, and results (Moctezuma-Ramirez et. al 2023). Finally, all of the experiments required for FDA approval of an IND required the use of a GMP drug substance with experiments conducted under GLP conditions. Companies should understand the importance and requirements for GLP/GMP studies.  These studies are more expensive but can result in delay of acceptance of an IND for human study initiation of the package of preclinical studies if it does not meet regulatory requirements. 

Note: This is an abridged version of the white paper.  The full-length version is available on the Mesa Science Associates, Inc. website:  https://www.mesascience.com/ 

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References

Aban, I. B., & George, B. (2015). Statistical considerations for preclinical studies. Experimental neurology, 270, 82–87. https://doi.org/10.1016/j.expneurol.2015.02.024

Bate ST, Clark RA. The Design and Statistical Analysis of Animal Experiments. Cambridge University Press; 2014. 

Bonapersona, V., Hoijtink, H., RELACS, Sarabdjitsingh, R. A., & Joëls, M. (2019). RePAIR: a power solution to animal experimentation. bioRxiv, 864652. 

Carneiro, C. F. D., Moulin, T. C., Macleod, M. R., & Amaral, O. B. (2018). Effect size and statistical power in the rodent fear conditioning literature - A systematic review. PloS one, 13(4), e0196258. 

Charmaine J.M. Lim, Sanna K. Janhunen, Gernot Riedel. Reproducibility in Preclinical in Vivo Research: Statistical Inferences. J. Integr. Neurosci. 2024, 23(2), 30. https://doi.org/10.31083/j.jin2302030 

Dechartres, A., Boutron, I., Trinquart, L., Charles, P., & Ravaud, P. (2011). Single-center trials show larger treatment effects than multicenter trials: evidence from a meta-epidemiologic study. Annals of internal medicine, 155(1), 39–51. https://doi.org/10.7326/0003-4819-155-1-201107050-00006 

Everitt J. I. (2015). The future of preclinical animal models in pharmaceutical discovery and development: a need to bring in cerebro to the in vivo discussions. Toxicologic pathology, 43(1), 70–77. https://doi.org/10.1177/0192623314555162 

Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of clinical trials. springer. 

Henderson, V. C., Kimmelman, J., Fergusson, D., Grimshaw, J. M., & Hackam, D. G. (2013). Threats to validity in the design and conduct of preclinical efficacy studies: a systematic review of guidelines for in vivo animal experiments. PLoS medicine, 10(7), e1001489. https://doi.org/10.1371/journal.pmed.1001489 

Howells, D. W., Sena, E. S., & Macleod, M. R. (2014). Bringing rigour to translational medicine. Nature reviews. Neurology, 10(1), 37–43. https://doi.org/10.1038/nrneurol.2013.232 

Huang, W., Percie du Sert, N., Vollert, J., & Rice, A. S. C. (2020). General Principles of Preclinical Study Design. Handbook of experimental pharmacology, 257, 55–69. https://doi.org/10.1007/164_2019_277 

Kilkenny, C., Parsons, N., Kadyszewski, E., Festing, M. F., Cuthill, I. C., Fry, D., Hutton, J., & Altman, D. G. (2009). Survey of the quality of experimental design, statistical analysis and reporting of research using animals. PloS one, 4(11), e7824. https://doi.org/10.1371/journal.pone.0007824 

Laajala, T. D., Jumppanen, M., Huhtaniemi, R., Fey, V., Kaur, A., Knuuttila, M., Aho, E., Oksala, R., Westermarck, J., Mäkelä, S., Poutanen, M., & Aittokallio, T. (2016). Optimized design and analysis of preclinical intervention studies in vivo. Scientific reports, 6, 30723. https://doi.org/10.1038/srep30723 

Landis, S. C., Amara, S. G., Asadullah, K., Austin, C. P., Blumenstein, R., Bradley, E. W., Crystal, R. G., Darnell, R. B., Ferrante, R. J., Fillit, H., Finkelstein, R., Fisher, M., Gendelman, H. E., Golub, R. M., Goudreau, J. L., Gross, R. A., Gubitz, A. K., Hesterlee, S. E., Howells, D. W., Huguenard, J., … Silberberg, S. D. (2012). A call for transparent reporting to optimize the predictive value of preclinical research. Nature, 490(7419), 187–191. https://doi.org/10.1038/nature11556 

Lazic, S. E., Clarke-Williams, C. J., & Munafò, M. R. (2018). What exactly is 'N' in cell culture and animal experiments? PLoS biology, 16(4), e2005282. https://doi.org/10.1371/journal.pbio.2005282 

Moctezuma-Ramirez, A.; Dworaczyk, D.; Whitehorn, J.; Li, K.; Cardoso, C.d.O.; Elgalad, A. Designing an In Vivo Preclinical Research Study. Surgeries 2023, 4, 544–555. https://doi.org/10.3390/ surgeries4040053 

Perrin S. (2014). Preclinical research: Make mouse studies work. Nature, 507(7493), 423–425. https://doi.org/10.1038/507423a 

Pound, P., & Ritskes-Hoitinga, M. (2018). Is it possible to overcome issues of external validity in preclinical animal research? Why most animal models are bound to fail. Journal of translational medicine, 16(1), 304. https://doi.org/10.1186/s12967-018-1678-1 

Warner DS, James ML, Laskowitz DT, Wijdicks EF. Translational Research in Acute Central Nervous System Injury: Lessons Learned and the Future. JAMA Neurol. 2014;71(10):1311–1318. doi:10.1001/jamaneurol.2014.1238.

MedSurgPI DSMB Capabilities

What We Provide: An experienced team of experts who have served on numerous data safety monitoring boards, safety review committees, adjudication boards, and are seasoned medical monitors.  This includes the physician chairperson, physicians, and administrator.

Our Approach:

• Identifying Medical Needs: The MedSurgPI Team of physicians can cover nearly all indications.

• Addressing Key Questions: Our team of physicians have the regulatory, safety, and scientific understanding of your protocol.

• The Chairperson: Our experienced physicians have served as chairpersons in multiple studies.

Understanding the Safety and Regulatory Pathway

• The safety and regulatory landscape can either accelerate or derail your timelines. Proactively engaging with regulatory bodies and leveraging existing frameworks ensures smoother progression.

• Key Considerations:

  • Do novel therapies require a customized safety and regulatory DSMB strategy?

  • Developing the DSMB Charter:

    • Assess the successes and challenges of similar products.

    • Design a tailored approach to align with your specific safety profile.

Ensuring Alignment and Effective Oversight (key elements)

• Addressing the Protocol and Investigator Brochure: ensure the DSMB charter aligns seamlessly with these critical documents.

• Biostatistician: Who will understand how to examine interim analysis.

• Administration: Ensure a seamless meeting process with an experienced administrator to manage logistics, oversee document disposal, and accurately record meeting minutes.

Top 10 Benefits of Remote Patient Monitoring for Clinical Trials

Written by: Gerald L. Klein, MD* Michael Fath, PhD* Sukhwant Khanuja, PhD** Roger E. Morgan, MD* MedSurgPI* Carematix Inc**

Introduction

The advent of wireless technology has revolutionized many sectors of healthcare, especially clinical trials and the medical assessment of homebound geriatric patients.  Wireless remote patient monitoring (RPM) can enhance the efficiency and effectiveness of decentralized and patient-centric clinical trials. Decentralized clinical trials (DCTs) are studies that are not limited to a geographical region but are conducted through the use of local investigators with telemedicine and remote patient monitoring.[1] RPM allows the expansion of these studies into more remote and diversified populations that are notoriously underrepresented.  The FDA has released guidance documents on the conduct of decentralized clinical trials.[2] Clinical research organizations (CROs)  now take advantage of both the use of decentralized and hybrid clinical studies which uses a combination of the two. Here, we explore how wireless RPM can improve clinical studies. View the entire article here

[1] Apostolaros M. Babaian D. Corneli Al et al. Legal Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative. Ther Innov Regul Sci 54, 2020: 779-787.

[2] https://www.fda.gov/media/167696/download

Mesa Science Associates and MedSurgPI announce a partnership

Mesa Science Associates, Inc. (MSA) and MedSurgPI, LLC have announced a partnership between their two companies, which will expand and consolidate the offerings of both to the pharmaceutical and bio-pharmaceutical research and development communities, offering a single source for services of particular importance to small and mid-sized biotech firms.

MSA is located in the Frederick Innovative Technology Center in Frederick, MD and specializes in drug-delivery development and clinical study design and operations. Its services include: consulting and management in the broad areas of Active Pharmaceutical Ingredient (API) sourcing; expertise in chemistry manufacturing and control; in vivo and in vitro pre-clinical and clinical-trial support services; and expertise in consulting on drug-delivery devices.

MedSurgPI is located in Research Triangle Park, NC and provides medical consulting for product development and medical affairs. Its suite of services includes: medical oversight for clinical studies; clinical strategy; medical monitoring; DSMB and SRC services; medical affairs; journal articles; fractional Chief Medical Officer services; and medical input for promotional (LMR) review.

Commenting on the partnership, Michael Mesa, MSA’s president, had this to say, “We look forward to working closely with MedSurgPI to bring a wider array of pharmaceutical development services to our clients.” Both companies believe their coordinated efforts will offer clients a powerful set of research guidance and management tools, beginning with preclinical studies and running all the way through FDA filings and post-marketing medical affairs. Dr. Gerald L. Klein, Principal of MedSurgPI said this about the partnership, “This collaboration with Mesa Science Associates will enhance our capacity to deliver robust preclinical and scientific consulting services to our clients.”

The services these two companies are bringing together are especially important for startup biotech companies, which don’t necessarily have the size and staffing to internalize such disparate capabilities under one roof. Small to mid-sized companies will now be able to access them from a single source, which will be a benefit to them and reassuring to their investors, which can range from private equity, to venture capital, to angel investors, and family funds.

About Mesa Science Associates, Inc.

Mesa Science Associates (MSA) is a veteran-owned small business located in the Frederick Innovative Technology Center Inc. (FITCI), located at 321 Ballenger Center Drive in Frederick, MD. MSA provides a comprehensive array of pharmaceutical development solutions to the research community, including the federal government. From product development planning to NDA or BLA submission, MSA’s flexible service model leverages a network of highly skilled research and research support professionals from across the U.S. to consult with laboratory specialists on: pharmacology; preclinical drug evaluation; clinical studies; CMC development; drug delivery systems; and regulatory consulting throughout the drug-approval process.

 About MedSurgPI, LLC

MedSurgPI is a pharmaceutical physician consulting company based out of Research Triangle Park in North Carolina. MedSurgPI provides medical expertise for clinical strategy, protocol review and development, FDA meetings, investigator meetings, and more. It also provides fractional (functional) medical services, including Chief Medical Officer, Medical Monitor, and Medical Director. MedSurgPI’s medical affairs capabilities includes medical communications, LMR review, KOL selection and management, and continuing medical education. MedSurgPI also offers comprehensive DSMB services, bringing together an elite team of experienced physician specialists, statisticians, and pharmacokinetic experts dedicated to serving as your DSMB. 

The AI Revolution in Pharma: Remaking Medical Affairs, One Insight at a Time

MedSurgPI, LLC is pleased to introduce the AI Revolution in Pharma: Remaking Medical Affairs, One Insight at a Time.  This document highlights the role of AI, not just as an automation tool but as a game-changer for medical affairs and stakeholder engagement.  Join us as we explore the evolving landscape of AI, promising a new era of innovation and strategic partnership.

By Michael Fath, PhD1,2; Gerald L. Klein, MD2; L. Allen Kindman, MD2; Larry Florin, MBA2; Victoria Manax, MD2; Shabnam Vaezzadeh, MD2

1Cavabio Consulting, LLC, 2MedSurgPI, LLC

Safety and Pharmacovigilance Tips

These Safety and Pharmacovigilance tips are aimed at improving the understanding of this area of clinical drug and device development. For example, clinical sites are frequently confused about the nuances of adverse event reporting, assessing causality, or the use of proper safety terminology. In addition, some sponsors may not be using the appropriate type of committee to oversee the safety of their clinical trial. See below for the first tip in this series and feel free to reach out to us with any questions: info@medsurgpi.com.

Clinical Investigators and their sites should establish a systematic way of assessing causality when adverse events and serious adverse events occur. The Bradford Hill criteria are an established practical way of determining these events[1]:

1. Strength of Association: a strong association between a treatment and an adverse event indicates causation. For example, each time the drug was given to a subject, it caused vomiting within a predictable time period.

2. Consistency: Established adverse event attributions or previous determinations in similar situations indicate causation.

3. Specificity. An established mechanism of action connecting the treatment and the adverse event indicates causation.

4. Temporality: exposure to the product must occur before the disease or event, and not after a latency period. However, temporality is not sufficient to establish causation.

5. Biological Gradient: a dose response effect is a strong argument for causation.

6. Plausibility: the causal relationship is biologically plausible.

7. Coherence: the known facts fit the natural history and biology of the disease.

8. Experiment: Epidemiologic studies indicate causation.

9. Analogy: a similar agent causes the same type of AE.

[1] Klein, G., Johnson, P. and Morgan R., Medical Monitoring of Clinical Research Studies. J. Clin. Res. Best Practices. 2021: Vol 17 (1)

Tips For Being A Good Medical Monitor

Gerald L. Klein, MD and Roger Morgan, MD

PROMPT RESPONSE TO INVESTIGATOR SITE QUESTIONS

• Answering questions about inclusion and exclusion (I/E) is an important function of the medical monitor.

  • A prompt response is necessary if the patient is waiting to be screened.

  • A clear explanation of your response

    • Document with the specific I/E criteria

      • Provide clear documentation for the Trial Master file/investigator and, if appropriate, furnish a reference article from the medical literature

  • If patient safety is involved, providing a quick response is crucial.

    • Examples of when a quick response is necessary:

      • Suspected Unexpected Serious Adverse Reaction (SUSAR)

      • If a question about the necessity of unblinding occurs

      • Serious adverse event that triggers the study to be stopped

      • A safety issue that needs to be discussed immediately with the site and or sponsor

  • It is important to have a backup medical monitor in place to provide this service continuously.

    • Provides coverage for holidays, vacations, or sick days

  PROVIDING MEDICAL REFERENCES

• Why provide medical or regulatory references?

  • To foster greater understanding of the entry criteria

  • To help the sites form better decisions in the future

  • To create mutual respect between the sites and the medical monitor

  • To help with better regulatory understanding of the study

ANSWERING QUESTIONS

• All questions from the sites should be added to a Question and Answer log (Q&A) and made available to other monitors who may be on the study as well as to clinical operations personnel.

  • This will ensure consistency and will help address future questions that are similar

  • Help the site decide about entrance criteria

  • May clarify some common questions that sites may have

  • Promotes minimization of protocol deviations

Neglecting Regulations and Quality System Requirements is Detrimental to your Business

Mark E. Ramser, VP Quality Management, MedSurgPI, LLC; Peter C. Johnson, MD, Principal, MedSurgPI, LLC; Gerald L. Klein, MD, Principal, MedSurgPI, LLC

It’s never too early to start designing and implementing a company’s quality management system (QMS). Initiating the R&D process is not a problem for companies that have a well-defined QMS and a mature understanding of how it should operate. However, without a well-defined, compliant and effective system, this could be the start of potential future quality and regulatory nightmares. Even with a well-defined system in place, significant problems can occur if the organization is lacking the maturity and experience to utilize it properly. Typically, the R&D function is where most people think a product starts. The founders may not have any understanding of regulatory or quality system requirements. They can simply be focused on developing and launching a product, choosing to worry about the regulatory and quality system requirements once they have a product to sell. Unfortunately, by waiting until the product is ready for market, it will be too late. The ISO 13485 standard, 21 CFR Part 820 (FDA Regulations) and MDR (European Medical Device Regulations) require and expect the product development and launch to be performed under controlled processes and systems. Refer to the following links for the above referenced standards and regulations:

• ISO 13485 (Quality Management System for Medical Devices)

• 21 CFR Part 820 (FDA Medical Device Regulations)

• MDR (European Medical Device Regulation)

The notified bodies and regulators expect the following areas to be controlled and managed per their documented standards and regulations:

The most critical in early stage product development are:

• Documented Quality Management System

• Design Controls (Design History File sub-bullets to prove all these areas are addressed)

  • Design and Development Planning

  • Design Inputs

  • Design Outputs

  • Design Reviews

  • Design Verification and Validation

• Change Management (design, system, process, supplier, raw material, etc.)

• Process and Production Control

  • Process

  • Equipment

  • Supplier Selection and Control

Many of these activities need to be initiated from the start of the R&D process and the establishment of a Quality Policy and Quality Process at the proper time falls squarely upon the CEO. Companies cannot generally recreate documentation history at later dates in preparation for an FDA or regulatory body audit. The company is then open to all the risks related to not having required systems during product development. The risks can vary based on the severity of the issue and can range from:

• A Form 483 may be issued to the firm. Form 483 is the communications method used by the FDA to inform the company’s management of objectionable conditions. This should be followed up with a thorough investigation, root cause analysis and corrective action within 15 days. These are available to the public, but only when specifically requested.

• Severe issues on Form 483 or a significant number of issues on Form 483 could result in the issuance of a Warning Letter. A Warning Letter is one of the FDA’s principal means of achieving prompt voluntary compliance with the Act. The warning letters are much more significant than a Form 483 and are publicly posted on the FDA website and are easily searchable. This must be followed up with a thorough investigation, root cause analysis and corrective action within 15 days.

• Additional actions can result in a consent decree, product seizure and up to and including criminal prosecution against the firm and individuals, with a special focus on the CEO.  A consent decree may be viewed as the equivalent to a court order under which the manufacturing and distribution of products can only resume, with conditions closely monitored by FDA.

The regulations defined in 21 CFR Part 820 are legal requirements and carry the stiff penalties noted above. This carries much more significance than merely an ISO standard that defines the requirements without having any legal recourse. One must keep this in mind from the earliest possible point of the inception of the company and not just during the product launch. Not following QMS at product inception and all along the development cycle can have dire consequences for the company.

The timing of onset and the complexity of any company’s QMS is dependent upon the risk that a product may represent when used with humans. Therefore, judgment and expertise are required to properly craft and institute such systems. MedSurgPI can assist your company at the earliest stages to institute a QMS, perform Gap Assessment and Corrective Actions for an existing QMS and assist with the ongoing management of a QMS. Please contact MRamser@medsurgpi.com for additional information.

James D. Hundley, M.D. of MedSurgPI co-authors book: My Hip Hurts!

James D. Hundley, M.D., Physician Associate with MedSurgPI, LLC has co-authored a book My Hip Hurts!: Causes and Treatment of Hip Pain in Seniors.  Authors Dr. Hundley and Richard J. Nasca, M.D. are two orthopaedic surgeons with over 100 combined years of training and experience.  This is an exciting book as Drs. Hundley and Nasca describe conditions of the hip suffered by older people, what can be done for them, and what they would recommend.  Simple drawings and x-rays are used for illustration along with a glossary to help understand medical terms.

This book is available through Amazon at the following link:  My Hip Hurts!: Causes and Treatment of Hip Pain in Seniors 

Globalization of Clinical Trials: Benefits and Risks

Aparna Shekar1,2, Gerald L. Klein, MD3, and Peter C. Johnson, MD3

1Ph.D. Candidate, Vanderbilt University, Nashville TN, 2Intern, MedSurgPI, LLC., Raleigh NC, 3Principal, MedSurgPI, LLC., Raleigh NC

Clinical trials are scientific experiments designed to test new medications, devices or other therapeutic interventions, or to further gain insight on those treatments for use in human medicine. They aim to produce insight into the safety and efficacy of medical interventions and strive to produce improvements in medical care. Clinical trials have evolved substantially since James Lind’s Scurvy trial in the 1700s1, to become more structured and supervised, and to generate more rigorous, reproducible results. But along with being thorough came a new set of challenges - clinical trials today face a gamut of scientific, ethical, regulatory and financial roadblocks. Biopharmaceutical development is a global business today.   Companies are routinely conducting clinical trials in foreign nations with the intent that the data will also to be used to support US claims2,3. In 2008, 80% of all marketing applications submitted to the FDA contained data from foreign clinical trials (https://oig.hhs.gov/oei/reports/oei-01-08-00510.pdf). There are several reasons for this trend, including but not limited to lower costs of conducting trials abroad. In 2013, the Tufts Center for the Study of Drug Development estimated that the total costs for developing, seeking approval and marketing a new chemical entity costs $2.6 billion on average, creating an impetus for decreasing the costs of clinical trials.  Countries that have grown to be popular choices for conducting clinical trials include those in Latin America, Asia, Europe and Africa where lower operating costs occur.  Some of these lower costs include  human resources, clinical procedure costs, site monitoring costs, regulatory, and compensation in case of injuries/deaths that may occur4. Other significant benefits of foreign clinical trials include the ability to enable globalized medical product discovery and development, expand diversity of the test subject pool, shorten drug development timelines and less litigious and, importantly, to test patients that are naive to treatments not found in third world countries. Due to these advantages, the number of foreign clinical trials conducted to meet US FDA regulations has more than doubled over the past decade.

However, there are major risks involved in conducting clinical trials outside the United States. Companies need to consider and prepare in advance to understand country-specific insurance requirements, legal restrictions and regulations regarding conducting clinical trials with human subjects. They also need to determine if the trial design conforms to FDA standards so that trial data can be accepted by the FDA for review. In the absence of prior careful consideration, sponsors may inadvertently violate local insurance laws, expose themselves to excessive liability, or even unknowingly purchase insurance coverage that is well beyond the requirements of a particular country. It is particularly important for sponsors to thoroughly understand and follow FDA guidelines for conducting clinical trials in a foreign country. Under Section 1123 of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, data from foreign clinical trials should be accepted by the FDA, provided such studies comply with U.S. federal standards on Good Clinical Practices (GCPs).  As of 2016, the FDA has issued guidelines stating that it may accept clinical trials conducted outside the US under the classification of an Investigational New Drug (IND) and comports with all FDA regulations as if the trial were being conducted within the United States. Additionally, it may consider a trial not conducted under the classification of IND, so long as the study conforms to whichever of the following rules provides greater protection of the test subjects: (i) the ethical principles contained in the 1983 version of the Declaration of Helinski or (ii) human rights regulations in the foreign country in which the trial is conducted. The new Questions and Answers (Q&A) Guidance from the FDA issued on February 21, 2018 provides further clarification on how to conduct these trials.  The International Conference on Harmonization (ICH) and World Health Organization Good Clinical Practice (GCP) standards provide a unified measurement for the USA, European Union, Japan, Australia, Canada, the Nordic countries and several others. A complete list of countries that have adopted this guideline is available online at www.ich.org. Additionally, research groups have also developed methods that can predict country-specific financial requirements, outcomes of trials and risks involved in foreign locations that are developing countries, that may help sponsors in identifying an appropriate country in which to conduct their trial5,6.  This new Q&A guidance document emphasizes the importance of a description of how investigators were trained to comply with GCP and how the study was monitored so that the investigations were done in accordance with the protocol (Section 812.28(b)(12)).

Ultimately, it is important to maintain scientific integrity and patient safety, which leads to better trial outcomes. Several resources are available that can help companies understand the strict guidelines that they are required to follow to manage potential risks. Companies can seek aid from experts on ICF and GCP guidelines, foreign insurance policies, medical insurance policies, informed consent requirements and FDA liaisons. Our experts from MedSurgPI, LLC. can aid pharmaceutical and medical device companies in making informed decisions and adopting appropriate steps before they embark on conducting clinical trials in foreign countries.  MedSurgPI, LLC. by providing experienced product development expert services to its clients is well positioned to bridge the business and medical understanding that such risk management requires.

References:

1          Lind and scurvy - 1747 to 1795.

2          Capeding, M. R. et al. Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial. The Lancet 384, 1358-1365, doi:10.1016/s0140-6736(14)61060-6 (2014).

3          Ezeome, E. R. & Simon, C. Ethical problems in conducting research in acute epidemics: the Pfizer meningitis study in Nigeria as an illustration. Dev World Bioeth 10, 1-10, doi:10.1111/j.1471-8847.2008.00239.x (2010).

4          Dezfuli, M. Outsourcing Clinical Trials Outside of the US. Pharmaceutical Regulatory Affairs: Open Access 06, doi:10.4172/2167-7689.1000194 (2017).

5          Lorenzo, C., Garrafa, V., Solbakk, J. H. & Vidal, S. Hidden risks associated with clinical trials in developing countries. J Med Ethics 36, 111-115, doi:10.1136/jme.2009.031708 (2010).

6          Hidden risks associated with clinical trials in developing countries.

Erroneous Assumptions in Drug Development →

Roger E. Morgan, MD, Gerald L. Klein, MD, Peter C. Johnson, MD, and Roger Nolan, PhD

Preventing Physician Burnout: Caring for those who care for us →

Aparna Shekar, Ph.D. Candidate; Gerald L. Klein, MD; and Peter C. Johnson, MD

Common Shortfalls in Clinical Supply Chain Planning →

We have been amazed at the complexity of the journey of clinical supplies to investigator sites is  and delays can be extremely costly for sponsors. In fact, supply chain logistics can account for up to 25% of total annual pharmaceutical R&D costs. With stakes this high, it’s important to understand the strengths and weaknesses of tools uses to plan such critical projects. 

Spreadsheet Models

The most common tool used for planning and managing Clinical Supply Chains are spreadsheet models.  While this approach has some attractive qualities (simplicity, familiarity, and ease of sharing results) they suffer from several drawbacks.

For basic or static analysis, spreadsheets are often the right tool. However, supply chains are not static. They have parameters, resource constraints, queues, and demand curves that will change over time. This is where spreadsheet models show their limitations in capturing real-world situations. Although they will provide an answer, if you only use averages as your inputs, you will always get the average result, and not the range of real-world possibilities.

Simulation

Due to the drawbacks of spreadsheet models, approximately 10% of pharma companies have tried to solve these shortcomings by utilizing more sophisticated, dynamic tools like simulation. However, while simulation solves many of the shortcomings of spreadsheet models, they also introduce new problems; namely complexity and lack of transparency. Developing realistic simulations of supply chains is not an easy task because the software is often proprietary and the learning curve for programming them can be extremely high unless you are a data scientist or software developer.

Due to these barriers, the management of clinical trial supply chains and approaches to minimize costs has received little attention in formal research [Chen, Mockus, Orcun, & Reklaitis, 2012]. Much of the research that has been done does not consider the inherent randomness found in real-world clinical supply chain systems. This makes much of the research less applicable to pharma companies because uncertainty and variability is inherent to patient enrollment, shipment lead times, and process delays [Chen et al., 2012].

 Alternatives

Given the challenges with both spreadsheet models and simulation, what are clinical trial supply chain decision makers to do? There are two possible solutions:

1)    Develop highly intricate and complex simulation models using Discrete Event Simulation (DES) software like ExtendSim (https://goo.gl/VFSHak) or Python SimPy in hopes of capturing all the aspects of a complex supply chain; or

2)    Simply eliminate the need and cost of the supply chain by providing subjects with a clinical study pharmacy card.

Some pharma companies take the first route and try to model complex clinical trial supply chains in hopes of maximizing efficiency and expediting clinical trials. Although not the easiest route, companies that wish to pursue this path would benefit from developing an understanding of dynamic programming and simulation optimization strategies. A good starting point would be a paper by Jung, Blau, Pekny, Reklaitis, and Eversdyk (2004), covering a simulation optimization approach to solve a generalized supply chain problem under demand uncertainty.

Using the RxStudyCard Instead of trying to build a large-scale simulation and then run hundreds of scenarios in hopes of identifying efficiencies, decision makers can simply eliminate much of it using a clinical study pharmacy card which leverages a network of over 60,000 retail pharmacies to deliver medicine and supplies to subjects participating in clinical studies. This type of program provides a safe and efficient method of dispensing unblinded medicines and supplies to study subjects that saves administrative effort, wasted supply overage, and time as well as reduces the amount of capital expense required by 30 to 60%, depending on the size of the study.

Chen, Ye, Linas Mockus, Seza Orcun, and Gintaras V. Reklaitis. “Simulation-Optimization Approach to Clinical Trial Supply Chain Management with Demand Scenario Forecast.” Computers & Chemical Engineering 40, no. Supplement C (May 11, 2012): 82–96. https://doi.org/10.1016/j.compchemeng.2012.01.007.

Jung, June Young, Gary Blau, Joseph F. Pekny, Gintaras V. Reklaitis, and David Eversdyk. “A Simulation Based Optimization Approach to Supply Chain Management under Demand Uncertainty.” Computers & Chemical Engineering, Special Issue for Professor Arthur W. Westerberg, 28, no. 10 (September 15, 2004): 2087–2106. https://doi.org/10.1016/j.compchemeng.2004.06.006.

Gerald Klein, MD

The Emergence of Population Health →

by Peter S. Liebert, MD, MBA

Decreasing Pediatric Asthmatic Hospitalization & Emergency Visits By Improving Adherence

Click to read full article.

 Gerald L. Klein, MD Peter C. Johnson MD, Roger Morgan MD

How Best to Leverage Medical Affairs Experts in Life Sciences Companies of Varying Size and Structure →

Shabnam Vaezzadeh, MD, MPA, Gerald L. Klein, MD, Peter C. Johnson, MD, 

Valerie Riddle, MD, Robert L. Wolfert, PhD