Clinical trial design for biopharmaceuticals is complex, requiring access to specific patient populations and a sharper focus on safety in order to clear regulatory hurdles. PLG assists start-up and midsize companies in integrating tailored clinical solutions for clinical trials from phase 1 through phase 3.
Deliverables:
- Statistics expertise
- Biostatistics expertise
- Development of an entire clinical plan
- Clinical monitoring
- Regulatory expertise
- Project leadership
- Investigation brochures
- Toxicology expertise
- Clinical study report writing and review
- Product information in the forms of company core data sheet (CCDS), summary of product characteristics (SmPC), and medical information materials