RS Serve offers high level Project Management and Monitoring of BA/BE Studies including:

  • Project contract, budgeting and negotiation
  • Time management from protocol design to report submission
  • Project initiation and in-study monitoring
  • Site Selection/Qualification Visits
  • Site Initiation Visits
  • On-Site Monitoring Visits
  • Site Closure Visits
  • Remote Monitoring

  • Technical discussion
  • Timely and extensive update to clients about the study progress
  • Bio-analytical Monitoring
  • Scientific document writing (protocol, Consent forms, Case report forms, clinical study report (clinical phase, bio-analytical phase, PK and Statistical phase of the report)
  • Regulatory Affairs (DCGI submission, BE NOC and T- License)

RS Serve has monitored more than 70 bioequivalence projects for US FDA and EU submissions. Extensive experience in qualification of BA/BE centers.

System/Facility Audit of BA/BE Centers:
RS Serve has an experience of auditing more than 10 BA/BE CRO’s in India for number of times.


Other services include: