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.