Versiti Clinical Trial Services guides our partners with decades of expertise and a commitment to excellence. Whether you need support for for your biopharmaceutical, medical device, or diagnostic solution, we provide tailored strategies and services to meet your needs and ensure safety and efficacy for impacted patients.
GCP, GMP and GLP Compliance
Expert support to ensure your clinical or commercial supply chain aligns with FDA, European and other global standards. Our services encompass compliance with GCP, GMP and GLP quality systems; vendor management plans; and risk mitigation strategies.
CAP and CLIA Adherence
For laboratories, we assist in maintaining CAP and CLIA adherence during both routine and non-routine clinical sample testing. Starting with a detailed gap analysis, we identify and address potential vulnerabilities before they become regulatory issues. Our solutions include ongoing monitoring to help keep your quality systems effective and up to date.
Areas of Expertise
We bring extensive expertise across the following areas:
- Clinical compliance—21 CFR Parts 50, 54, 56, 312, 314, 361
- Manufacturing standards—21 CFR Parts 210, 211, 111, 820, 600, 601, 610
- Non-clinical research—21 CFR Part 58
- Electronic records/signatures—21 CFR Part 11
- ISO standards—13485, 14155, 14971, 22716, 9000 series
- ICH guidelines—Q7A, E6, E2A
- Compounding pharmacy—USP 797
- European directives—2001/20/EC, 2005/28/EC