Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
Strategies and innovations related to how clinical professionals are utilizing technology internal and external to their organizations to advance clinical trials. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
Through PAREXEL Regulatory Outsourcing Services, the Company will customize these services for clients based upon their unique needs and business challenges by combining expertise, operational approaches and technology. The service line will reside within the PAREXEL Consulting business segment.
“With the ever-changing regulatory environment, pharmaceutical companies face new challenges that need to be addressed with efficiency and cost in mind,” said Mark A. Goldberg, M.D., President and Chief Operating Officer, PAREXEL. “PAREXEL is uniquely positioned to provide this new service offering, given our regulatory expertise, global operational capabilities and information management technology. Clients will now be able to outsource significant portions of their regulatory activities to a trusted partner in a cost-effective manner.”
“Regulatory outsourcing is growing increasingly important in the market as more and more companies rely on outsourcing to help them with the complex task of managing their regulatory needs, especially the regulatory maintenance of their marketed products,” said Rick Riegel, Corporate Vice President and new head of the PAREXEL Regulatory Outsourcing Services line. “This service offering provides a unique solution that addresses new pressures felt by our clients, allowing them to become more efficient in the area of regulatory operations and affairs.”
The launch of PAREXEL Regulatory Outsourcing Services broadens PAREXEL’s portfolio of regulatory information management solutions. In 2012, PAREXEL’s acquisition of LIQUENT, Inc. strengthened its regulatory capabilities by adding a robust information technology platform, LIQUENT InSightR.