CCSA Site Support, Quality Assurance, and Monitoring
For our government and private clients, we have scheduled and performed on-site and remote study conduct monitoring, quality control/quality assurance (QC/QA), and data auditing for more than 200 phase 1–3 studies carried out in the US and internationally. CCSA has prepared visit reports, corrective action plans, and follow-up communications strategies to assist investigators in resolving discrepancies. We have designed and implemented numerous clinical trial conduct tools, such as protocol, IC, and CRF templates, as well as SOPs and guidelines, to assure compliance with federal and international regulations and guidance [e.g., Title 21 CFR Part 312.23 and International Conference on Harmonization (ICH); good clinical practices (GCP): Consolidated Guideline (Fed Reg 62 (90): 25691–25709, May 9, 1997)].
For our government and private clients, we have scheduled and performed on-site and remote study conduct monitoring, quality control/quality assurance (QC/QA), and data auditing for more than 200 phase 1–3 studies carried out in the US and internationally. CCSA has prepared visit reports, corrective action plans, and follow-up communications strategies to assist investigators in resolving discrepancies. We have designed and implemented numerous clinical trial conduct tools, such as protocol, IC, and CRF templates, as well as SOPs and guidelines, to assure compliance with federal and international regulations and guidance [e.g., Title 21 CFR Part 312.23 and International Conference on Harmonization (ICH); good clinical practices (GCP): Consolidated Guideline (Fed Reg 62 (90): 25691–25709, May 9, 1997)].