What to Know
The regulatory submissions required during all phases of clinical data collection, trials, and monitoring are many. Managing the volume of technically and clinically demanding tasks requires an experienced and clinically trained project manager.
Every phase of the clinical trial must be captured for reporting. Disease and condition data must be prepared to complete therapeutic indication reports. Each activity must be performed according to strict processes, PM plans and SOPs, as well as follow ICH-GCP guidelines.
How We Can Help
- Provide project management for all clinical phases
- Serve as the communication liaison between client, team, and regulators
- Lead and direct full development team
- Plan, create, and execute timelines, quality planning, and budget deliverables
- Identify and implement process efficiencies