Infinitus conducts and manages independent reviews and audits of clinical trial investigator sites, research groups, data management audits and sponsor clinical operations, to ensure compliance with Good Clinical Practice (ICH-GCP), FDA, EMEA and local regulatory standards as part of clinical trial services.

Individual contracts for investigational sites and other CROs are also taken up by our Quality Assurance (QA) Team. The QA team includes professionals with a background in clinical monitoring, auditing & development and implementation of quality systems

Infinitus Clinical Research Quality Assurance assures that both internal and external programs meet all obligations to their customers and regulatory authorities through a program of internal and external audits. Further, since Infinitus’ people are its key competitive advantage, management ensures that all necessary and ancillary training and education are available to the QA and other teams to ensure they are on the cutting edge of topics in the clinical research industry.

As a result, Infinitus Quality Services are continuously improving, driven by the changing regulatory environment and requirements, increasing quality demands and sponsor requests to meet the highest quality standards.

Our multilingual QA staff can assist you to “get it right the first time”, because  the individual team members have a broad experience and have held various positions within Quality Assurance and Clinical Operations in the (bio) pharmaceutical  industry for a considerable number of years