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.

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