Medical Group Functions/Services

 

Prepare Clinical Development Plans for

  • Registration; or,
  • Local Product Development

Provide In-Depth analysis of Investigational Leads/Competitors

 

Pharmacovigilance Support:

  • Expert Reports
  • SAEs Assessments/Narratives
  • PSURs
  • Data Bases Reconciliation

Consultancy on Scientific/Medical Affairs

Consultancy and Interaction with Regulatory Authorities:

  • Price Negotiations
  • PSURs/Expert Reports
  • Pharmacoeconomic Reports

Preparation and Facilitation of Advisory Committees Meetings

Facilitate Dialogue between Pharma Cos/Cooperative Groups

Clinical Trials Support: Respond and Follow-up with ECs/Regulatory Affairs

  • Follow-up with ECs Regulatory Authorities 

Medical Writing

  • Protocols
  • CRFs
  • Abstracts/Posters
  • Papers
  • Final Reports ( ICH)  
  • Product Dossiers
  • Investigators Brochures Reports
     

Clinical Operations Support:

  • Medical Monitoring
  • Therapeutic Areas Training
  • Medical Leadership
  • Protocol Amendments
  • Clarifications to ECs/Regulatory Authorities

DM/BS Support:

  • Medical Review of Statistical Analysis Plans
  • Queries Plans Generation
  • AEs Codification
  • Medical Review of Statistical Reports

 

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