GCP and BA/BE Services
“We are providing services related to “Good Clinical Practices” GCP and Bioavailability/Bioequivalence (BA/BE).”
GCP QMS/auditing services:
- Investigator Site audits
- TMF audits
- Study documents audits (protocol, ICFs, study reports etc.)
- 3rd party vendors (Clinical laboratories, CROs, Drug depots, Phase I & BA/BE centers, Translators and ECs)
- Data Management audits (clinical DB and process audits)
- Statistical programming and Clinical Study reports audits
- CSV audits
- Pre-inspection preparedness /mock inspection
- Handling serious quality issues, leading for cause investigation, Root cause analysis and CAPA management SOP development
- Customized GCP training & auditors’ skill development
Bioavailability/Bioequivalence (BA/BE) Services:
Audits:
- Qualification and requalification of BA/BE CROs
- Audit of patient PK based studies
Monitoring:
- Site Initiation Visits, On-Site Monitoring Visits, Site Closure Visits
- Monitoring of BA/BE studies including PK based BA/BE studies
- Bio-analytical Monitoring (In-process and retrospective)
Project Management:
- Project contract, budgeting and negotiation
- Technical discussion with Sponsors and CROs
- Timely and extensive update to Sponsors about the study progress
- Scientific document writing/review (protocol, ICFs, CRFs, CSRs)
- Regulatory Affairs (DCGI submission and approvals)
