Ricerca Biosciences/Instem Collaboration Delivers Improved Quality In Drug Safety Studies

Ricerca Biosciences, an integrated preclinical contract research organization (CRO) providing services to the biopharmaceutical industry, is pleased to announce the successful result of a partnership with Instem, a leading provider of laboratory data and information management solutions. The collaboration resulted in the development of a novel approach to eliminating potential misdosing during drug safety studies.

With the goal of improving quality management processes for clients and ensuring the integrity of study data, the Ricerca team in Lyon, France, approached Instem and proposed an upgrade to their Provantis software suite, which would help eliminate dosage errors. The Ricerca team created the requirement specifications and Instem enhanced the latest version of Provantis, enabling it to automatically verify and control correct dosing before administration by using existing bar code technology. The enhanced functionality replaces manual controls, which are not completely reliable, and streamlines the drug dosing process, thereby eliminating the potential for errors.

"We have been using the Provantis system for years," stated Stéphane Bulle, Senior Vice President and General Manager at the Lyon site. "Implementing this enhancement improves our exacting quality and productivity standards and assures our clients of timely, accurate and reliable study data."

A Lean Sigma project was initiated to optimize the new process with the objective of ensuring that it could be adapted to all study types. Several different pilot studies were successfully ran in 2010 and the studies confirmed the effectiveness of the new process, which is now standard procedure for all Ricerca studies.

"This project illustrates Ricerca's innovative approach to drug safety studies. We are continually looking for new ways to improve our clients' experience and to improve the quality and accuracy of their study data. It demonstrates our commitment to meeting our clients' changing needs," Bulle said.

About Ricerca Biosciences

Ricerca Biosciences, LLC, offers a comprehensive suite of discovery, preclinical and development services to support drug candidates from discovery through IND and NDA on a global scale. Capabilities include molecular through in vivo screening and profiling, medicinal chemistry, IND-enabling toxicology, API process chemistry and cGMP manufacturing of clinical and commercial API. At Ricerca, our scientific excellence and reliable, cost-effective strategies help accelerate your drug discovery programs via our U.S. based facilities in Concord, Ohio, and Bothell, Washington, and our ISO 9001-certified facilities in Taipei, Taiwan, and Lyon, France. The Lyon and Bothell facilities also hold AAALAC certification.

SOURCE: Ricerca Biosciences