QA Activities

for Clinical Trial

 

Therapeutic Area Experience
Focus on NIS
Regulatory Trials
e-CRF
QA Activities
Medical Writing
Phv in Clinical Trials

PRIOR TO STUDY INITIATION

Vendor selection and audit (GMP, GLP)

Quality Check of the study documentation:

  • Study Protocol
  • IMP Randomization, Labeling and Blinding procedures
  • CRF Design, Annotation and Logical Checks
  • Patient Information Sheet and Consent Form (PIS/ICF) for study
  • PIS/ICF for Treatment of Personal Data
  • Master Clinical & Financial Agreement with Clinical Sites
  • CTA Form and Other Documents to be submitted to CA and ECs
  • Monitoring Plan and Data Management Plan
  • Data Validation Plan

DURING THE STUDY

  • Internal audit on Sponsor File
  • Site Audits (Routinary And/Or “For Cause”)

END OF STUDY

  • Quality Check of Clinical Database
  • Quality Check of Clinical Study Reports
  • Quality Check of TMF