Thermo Fisher Scientific helps optimise productivity of bioequivalence studies and regulatory compliance

Thermo Fisher Scientific Helps Optimize Productivity of Bioequivalence Studies and Regulatory Compliance for CRO Customer

Since the implementation of Watson LIMS at IPRC’s Phase I unit, the company has benefited from significant productivity improvements, efficient assay validation, timely bioanalysis of samples, seamless instrument interfacing, easy sample tracking and reliable reporting of results.

Watson LIMS is a highly specialized, protocol-driven LIMS for drug metabolism and pharmacokinetic (DMPK) studies and is used as standard in bioanalytical laboratories in 18 of the top 20 global pharmaceutical companies and leading contract research organizations (CROs). It is designed to benefit pharmaceutical companies and CROs by offering secure data transmissions between pharmaceutical sponsor and CROs, helping ensure regulatory compliance, enabling reliable audit trails and thereby improving time to market.

Founded in Amman, Jordan, in 1997, IPRC is a privately owned CRO providing effective and reliable clinical services to the pharmaceutical industry in the Middle East and North Africa (MENA) region, Europe and the US in accordance with GxP guidelines and international regulations. To date, IPRC has conducted more than 800 bioavailability and bioequivalence studies and has developed and validated 195 bioanalytical methods. On a daily basis, a team of dedicated, highly qualified professionals is required to perform a large number of sample analyses with the aim of providing pharmaceutical customers with advanced clinical research results in a timely manner. In order to manage the increasing analytical requirements, IPRC needed a laboratory information management system that would enable the company to optimize the reporting of study results while safely archiving all study-related data. The company selected Thermo Scientific Watson LIMS due to the system’s purpose-built functionality for bioanalytical testing applications.

The LIMS has facilitated efficient study design and data transfer between researchers, enabling IPRC to benefit from improved operational efficiency,” said Dr. Isam Salem, vice president, operations, IPRC. “We also achieve accelerated laboratory turnaround, reduced costs associated with sample management and regulatory compliance with GLP and 21 CFR Part 11 requirements.”

“We’re confident our informatics solutions can provide IPRC with the tools and securities it needs to deliver expertise and technically advanced clinical research services in a timely manner and in compliance with local and international regulations,” said Dave Champagne, vice president and general manager for Informatics at Thermo Fisher Scientific. “The purpose-built functionality of Watson LIMS has delivered improved efficiencies and reduced validation time for IPRC, contributing to significant time and cost savings. This implementation demonstrates our dedication to providing high level expertise to the Middle East pharmaceutical industry through the strength and services of our Informatics Global Partner Alliance program, which has been pivotal in expanding our geographical reach into this important region. Watson LIMS enables CROs, like IPCR, to realize their goal of becoming strategic partners with their pharmaceutical customers and facilitates seamless communication with sponsors.”

For more information about Thermo Scientific informatics solutions, please call +1-866-463-6522 (U.S.), +44 161 942 3000 (EU) e-mail [email protected] or visit www.thermoscientific.com/informatics.