Conducting clinical trials at multiple sites in multiple countries is now common practice in the drug development sector.
While such multi-site programmes are thought to help reduce the cost of trials by, for example, boosting patient recruitment rates, they are often more difficult to manage because they and involve complying with differing rules set out my regulatory bodies in a number of countries.
As a result, contract research organisations (CRO) are increasingly turning to third-party firms to help manage the complex compliance and reporting regulations, with Kendle’s accord with MetricStream being just the latest example.
Under the new deal, Kendle will employ MetricStream’s audit management software to automate the tracking of compliance and quality assurance events across its global trials programme.
A key feature will be use of “risk-based” management to streamline Kendle’s clinical quality assurance activities, from periodic and ad-hoc audit schedules through the tracking of observations, recommendations and the resulting responses.
Kendle will also use MetricStream’s corrective action/preventative action (CAPA) software to monitor the effective implementation of corrective measures as and when they are necessary.
The web-based software will be accessible by Kendle’s 3,600-strong workforce of research employees which, the CRO believes, will allow it to respond to the constantly evolving global regulatory environment.
Christopher Bergen, Kendle’s chief administrative officer explained that: “Critical initiatives, such as the MetricStream implementation, enhance Kendle’s ability to anticipate and respond to the constantly changing environment in which we operate.
He also suggested that the system “[will] improve cycle times for our clients, as well as reducing regulatory liabilities, risks, and costs for Kendle.”