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