
While standard monitoring visits focus primarily on source document verification, protocol deviations, drug inventory, recruiting, and enrollment issues, SEEVs go beyond traditional monitoring and into the specifics of endpoint collection, ensuring that every detail is standardized and controlled at each clinical site. The outcome is results with integrity, data with low variability and decreased placebo response creating a decisive development path.
SEEVs provide detailed review of the data collection methods, procedures, and equipment. Clinical site staff perform mock procedures with specially trained CPC team members to ensure consistent elements in collecting the critical data, methodologies, attitudes, and practices of the site staff.
SEEVs provide the training for endpoint collection; in addition, it is vital to recognize endpoint collection issues in real-time. CPC Core Labs provide a solution to real-time review of your endpoint data. Unique to CPC's Core Lab is the prompt identification of endpoint issues and correction through timely feedback to the sites; therefore, minimizing their impact on your trial results.
CPC Clinical Research has developed innovative endpoint core labs in many different areas (e.g., Treadmill Testing, 6-Minute Walk, Pulmonary Function Testing (PFT), Wound Assessment, and more). Our endpoint core labs provide central and standardized solutions for reviewing data collection methods, evaluating data quality, and providing expert data interpretation.
The SQuAd Committee convenes frequently and allows quick and consistent problem solving to the unique endpoint issues that inevitably arise during trials. This committee includes Dr. William Hiatt, Dr. Neil Goldenberg, Dr. Tim Bauer, other clinical scientists, CPC project KOLs, Project Managers, and the CRAs who are doing the hands-on review of the endpoint data. This committee provides thoughtful solutions for consistent correction of site errors producing a higher degree of endpoint data quality.