A sampling of MedSurgPI’s clients and the services provided since its inception in autumn 2015 include:
1. Support for FDA interaction with a novel pulmonary imaging company.
- Regulatory Strategy
- Protocol Review
- Assist in CRO selection
- KOL Development
- Future, Publication Strategy and Planning
- Creating Manuscripts
2. Providing Medical Monitoring, Safety and Pharmacovigilance for a Phase III Clinical Trial. This drug is a hematology product. We will also work closely with their DMC.
3. Provision of interim Chief Medical Officer and business advisory services to an international diagnostics company that is developing next generation sequencing technology to stratify multiple tumor types and guide specific therapy.
4. Virtual Chief Medical Officer services and business strategy services for an advanced metabolic diagnostics company. Managing KOL selection, recruitment and meeting facilitation, running a healthy cohort study through two CROs, overseeing alpha assessment of diagnostic application. We are also helping them achieve regulatory approval of their new diagnostic tests.
5. Identification and recruitment of key opinion leaders to provide advice to a major international non-profit health care initiative.
6. Co-Chairmanship of an international meeting to evaluate the application of stem cells in musculoskeletal disease. Service on the host company’s Scientific Advisory Board.
7. Provision of a strategy to reverse Medicaid’s decision in a major US state to remove an asthma medication from the State formulary. Publication of blog and manuscript materials in support.
8. Provision of medical advice to an amniotic tissue therapeutics company with regard to the reversal of FDA tissue rules pertaining to amnion. General Medical Affairs services.
9. Identification and recruitment of non-conflicted Key Opinion Leaders to evaluate substantial initial investment in promising academics developing novel therapeutics by a major non-profit drug discovery initiative.
10. Provision of “path to IND“ strategy to a first in class biologics company utilizing a novel cellular component to treat acute neurologic disease.
11. Providing medical input to the Board of a large Japanese Nutrition Company for the development of a new product. This included the clinical development program.
12. Scientific strategy for a small CRO. This includes writing articles, presenting at conferences and interacting with potential sponsors.
13. Obtaining KOLs and helping create manuscripts for a branded generic medication. The development and management of a Phase IV clinical strategy.
14. MedSurgPI is consulting with a midsize medical publisher to help increase its market share. This includes new medical publications, trade journals, blogs, and conferences.
15. Providing Quarterly Content for a Major Medical Trade Publication. This consists of writing about the latest developments in product development, marketing, and regulatory affairs.