BE/BA Services

Specialty PharmaSource offers high level Technical, Project Management, Monitoring and Auditing of BA/BE Studies including:

  • Project contract, budgeting and negotiation
  • Time management from protocol design to report submission.
  • Protocol synopsis, review of protocol, 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 update to sponsors about the study progress
  • Bio-analytical Monitoring
  • Regulatory Affairs (DCGI submission, BE NOC and T- License)

We can take complete sponsorship on behalf sponsor in the execution of BA/BE studies.