CRO Covance has launched external laboratory management services, a new offering that provides biopharmaceutical companies with a management solution for external laboratory testing associated with clinical trials.
The services are designed to maximize the quality and integrity of clinical study data by ensuring specialty laboratory testing is managed for the client along with services provided by a central laboratory. These services include laboratory selection and qualification, auditing, vendor management, contracting and data cleaning. The new services will be managed by a team within Covance's central laboratory services and complement the company’s capabilities in central laboratory testing, biosample management and data services, resulting in a streamlined solution freeing pharmaceutical companies from the challenges of managing multiple laboratory testing vendors.
By leveraging economies of scale and minimizing duplication of effort, Covance’s external laboratory management services can reduce the cost of managing external testing by as much as 65% as compared to clients’ in-house management of the process. In addition, improved data cleaning can decrease the length of trials, accelerating data lock.
“Through our external laboratory management services, ISO-15189 accreditation, and understanding of the regulatory landscape, Covance is positioned to enable our clients to meet higher levels of data scrutiny from agencies around the globe,” said Gary Paul, global director of quality assurance for Covance Central Laboratory Services.
Paul Kirchgraber, vice president global laboratory operations and medical affairs, said, “By providing an enhanced laboratory data solution that reduces regulatory risk and lowers drug development cost, we enable our clients to focus on their core competencies, ultimately accelerating development and commercialization timelines.”
In recent years, increased regulatory scrutiny of clinical programs has led to the creation of an industry standard, ISO 15189, to help control laboratory data consistency and quality. While the majority of clinical trial testing occurs at central laboratories, an increasing percentage of trials include at least one specialized test sent to an external lab. Covance’s new external offering can help biopharmaceutical companies address their growing testing needs while mitigating potential risks.