Pharmapace medical and statistical professionals have a proven track record of superior leadership and success in clinical development plan and strategy that support full medical-use and commercial objectives for your clinical program. Our close working relationship ensures that our clients’ development efforts are medically and statistically sound and meet current regulatory requirements.
Clinical Development Consulting Core Services:
- Provide medical and statistical expertise on development programs
- Serve as internal biometrics function to oversee other CRO’s work
- Provide medical monitoring, safety review of clinical trial data, application of stopping rules and regulatory expertise regarding AEs/SAEs and reporting
- Chief Medical Officer for start-up companies that lack a full-time, in-house medical department but need an experienced medical development leader
- Design clinical study protocols
- Data Monitoring Committee (DMC) membership, setup, and charter writing