CRO Covance has launched an external laboratory management service offering for biopharmaceutical sponsors looking to external lab testing for its clinical trials.
Covance claims that the external laboratory management services can reduce the cost of managing external testing by as much as 65% when compared to clients’ in-house management of the process.
Dr. Paul Kirchgraber, VP of Global Laboratory Operations & Medical Affairs, told Outsourcing-Pharma.com, “With standardized quality agreements, audit procedures, and data management, we don’t just manage clients’ samples; we ensure global data quality, which reduces the risk of regulatory challenges. And our data cleaning and resolution processes enable faster data locks – a critical factor in the drug development timeline.”
The new Covance services are expected to complement the company’s capabilities in central lab testing, biosample management and data services to offer sponsors a one-stop shop for the combined services.
The expansion also comes as Covance has seen its central labs business grow considerably over the past year and drive the company’s overall results.
The launch of this latest service “was based both on specific client requests as well as extensive market research that demonstrated a desire from our clients to move from fragmented oversight to streamlined external laboratory management under a single provider,” Dr. Kirchgraber told us.
“In addition, we have seen a trend from regulatory agencies requiring more oversight of niche laboratories,” he added.
A recent increase in regulatory scrutiny of clinical programs has led to the formation of an industry standard, known as ISO 15189 , to help control lab data consistency and quality. Even though the majority of clinical trial testing occurs at central labs, an increasing percentage of trials include at least one specialized test that is sent to an external lab, Covance said.
The offering will also add new positions at the company.
“Covance has created several new roles dedicated to this service offering including external laboratory leader, quality assurance, and outsourcing manager roles,” Dr. Kirchgraber said. “Because of client interest, more hires are planned for next year as well, bringing the total new hires to approximately 15 by the end of 2014.”