Medical Consulting Services:
Pre-clinical and clinical program development, operations management and recruiting.
Capabilities include:
- Strategic Planning (corporate & regulatory)
- Protocol Design (Phases I – IV – Drugs, biologics and devices)
- Medical & Safety Monitoring
- Medical Affairs (Post-Mktg) Program Development & Copy Review
- Regulatory Affairs - FDA & EU expertise (pre-IND, IND, IDE, BLA, 510k, PMA – filing, reporting and associated processes)
- Operations Management
- Team Assessment & Building
- Medical Writing and GCP auditing
- DSMB Committee Formation or participating member
- IBC Committee Formation or participating member
- IRB Committee member
Areas of Clinical Trial/Development Experience:
Therapeutic Categories:
- Oncology
- Gene Therapy
- Vaccines
- Medical Devices
- OB/GYN
- GI
- GU
- Women’s Health
- Intranasal Drug Delivery
- Cardiac
- Neuro