Management of Bioavailability/Bioequivalence (BA/BE) Studies

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:

• GCP auditing and consultancy
• Validation and Compliance Services for Computer/Lab Systems
• GMP audits
• Training/Mock Inspection/SOP development and Management