Quality &
Quality Embedded for
Audit-Ready Execution
Quality and compliance are built into every REV Clinical project. We prioritize patient safety, data integrity, disciplined execution, continuous monitoring, ongoing staff training, and dedicated QA/QC oversight. All studies are supported by rigorous SOPs that comply with Good Clinical Practice (GCP), 21 CFR Part 11, and ISO standards. Our proven record of inspection and accreditation ensures that studies meet regulatory expectations and deliver reliable, audit-ready outcomes.
Demonstrated
Track Record of
Clinical Compliance
We embed compliance at every step to protect patients, safeguard data, train teams continuously, and verify compliance with rigorous SOPs for inspection-ready outcomes.
01
Clinical pharmacology services characterize the safety profile for every new drug candidate, informing risk mitigation and safeguarding participants throughout the study.
02
Regimented protocols protect patient data and records, with controlled access and documented management at every step.
03
Compliance is embedded in culture: all of our team members and clinical site teams complete rigorous onboarding and continuous training, ensuring role-specific proficiency and audit readiness.
04
A fully dedicated QA/QC team monitors patient responses and study performance from project inception through close-out, ensuring strict adherence to regulations. Activities are verified against CBCC’s 130+ detailed SOPs, providing traceable, consistent execution and defensible, inspection-ready documentation.
Licenses,
Certifications
& Audit Inspections
Since 2021, 50+ regulatory inspections have been completed, with no material issues identified.
Audit History
| Year | Locations | Regulatory Agencies | Number of Inspections |
|---|---|---|---|
| 2025 | U.S., India | FDA, MOH Kazakhstan, ISO | 10 |
| 2024 | U.S., India | FDA, ISO | 10 |
| 2023 | U.S., India | FDA, EMA, ISO, CDSCO | 24 |
| 2022 | India | FDA, ISO | 8 |
| 2021 | India | ANVISA ISO and CDSCO | 3 |
| 2019 | India | FDA | 2 |
| 2018 | India | FDA | 1 |
REV Clinical’s
Integrated Clinical
Trial Solutions
Discover our comprehensive capabilities and services that accelerate clinical study startups, enhance execution, and mitigate risks.
REV Clinical’s
Therapeutic
Expertise
Explore our areas of focused therapeutic experiences and expertise.
Let’s Move Your Study Forward
Interested in connecting with REV Clinical’s team of interdisciplinary experts to answer questions, take action on your RFP, and clearly define next steps?