Two US-based specialists in regulatory compliance for clinical trials have formed a joint venture offering global consultancy services for the development and implementation of good clinical practice (GCP) and human research protection (HRP) standards and programmes.

The venture, Provision Research Compliance Services, combines the GCP quality-assurance expertise of Falcon Consulting Group with the HRP capabilities of Schulman Associates IRB.

From its headquarters in Cincinnati, Schulman offers institutional review-board (IRB) services across all phases and therapeutic areas of clinical research in the US, Puerto Rico and Canada.

Philadelphia-based Falcon Consulting is a leading provider of clinical quality-assurance and good clinical-practice services globally to the pharmaceutical, biopharmaceutical, medical device and healthcare industries.  

Provision Research Compliance’s services will be available in more than 30 countries. The aim of the joint venture is to improve quality standards and data integrity in clinical trials while optimising the protection of human-research subjects.  

Standards challenge

With global clinical trials potentially involving hundreds of sites in a dozen or more countries, companies need to achieve consistent quality and ethical standards in human-subject protection and compliance if they are to minimise regulatory risk, the new partners note.

Meeting those standards, though, is complicated by outsourcing of services and the increasing complexity of clinical research.

"There has never been a collaboration of GCP and HRP industry leaders specifically focused on meeting the compliance needs of research institutions around the world,” said Michael Woods, president, chief executive officer and institutional official at Schulman Associates IRB.

"Provision makes it easier for institutions to achieve their compliance goals and to engage in global development programmes. It also helps study sponsors follow a simpler path to consistent compliance practices across a global network of research institutions.”