Typically, quality of a clinical trial is assessed by audits. Quality related audit in clinical trials, as in many other fields is a retrospective exercise. However, to ensure, consistent quality in clinical trials, it is important to make the quality assurance team an integral part of the whole process, from design to submission of reports. Instituting a regular internal mentoring, monitoring and auditing process, Clinfound Quality Management team not only helps the sponsors and CROs to avoid unpleasant surprises later, but will enable them to detect and bridge gaps very early in the process. Quality Control comes about through the strict adherence to the ICH GCP requirements, SOPs used in the study and all applicable local authority regulations.

Maintaining accuracy and quality throughout a clinical study is a contuinual, dynamic process. Although study requirements are carefully set forth initially in detailed documents such as clinical trial protocol and accompanying statistical analysis plan, expectations and requirements can change during a study. Clinfound helps you to tackle these issues with help of :

• Unified Standard Operating Procedures for Site Management
• Internal Mentoring programs for clinical Trial Team
• Continuous Research Education Programs for Clinfound Staff
• Internal Audits at investigator sites