Parexel adds flexibility to its clinical research offering

Boston-headquartered biopharmaceutical services provider Parexel has launched a new unit within its clinical research offering that allows clients to outsource particular functions rather than full development programmes.

Parexel Functional Services, which will sit within the company's Clinical Research Services business segment, will cover areas such as clinical operations, data management, biostatistics and medical writing.

In addition, the services will be offered through a number of different models, such as insourcing/staffing, full functional outsourcing and on a customised basis. The models may form the basis of a strategic partnership or else be part of a hybrid partnership that includes functional and pragmatic outsourcing.

“Clients increasingly need flexibility when choosing an outsourcing model that aligns with their path to drug development,” said Mark Goldberg, Parexel president and CEO.

“By creating this operating unit, we are taking a more proactive and focused approach to compete in the growing global functional services market. Of particular importance, we'll be able to strengthen our relationships with clients of all sizes by providing a broader mix of full programmatic and functional outsourcing.”

Leading the new operating unit will be Parexel's corporate vice president, Clinical Research Services, Diego Glancszpigel, who said: “Biopharmaceutical companies are challenged today with streamlining the drug-development process to deliver the safest, highest quality products in the most efficient and cost-effective manner.

“Parexel's depth and breadth of scientific expertise, along with our extensive global reach and low-cost locations, will be leveraged across functions to add value to each engagement.”

Parexel expands post marketing surveillance services in Japan


Meanwhile, the company has expanded its Peri-Approval Clinical Excellence (PACE) services, which assists biopharmaceutical companies, both global and Japan-based, registering their products in Japan to fulfil regulatory Post Marketing Surveillance (PMS) requirements.

The localised services, which cover phase IIIb/IV trials, include site monitoring and site support activities, data management and programming, statistical analysis and pharmcovigilance.

“Increasing regulatory demands for long-term safety data on pharmaceutical products has contributed to an exponential increase in the number of peri-approval studies across Asia,” said Carol Collins, corporate vice president and worldwide head of PACE at Parexel.

“Parexel offers a cost-effective and user-friendly operating model that can improve PMS compliance and data quality. This helps to create more effective utilization and maximise market penetration for biopharmaceutical companies.”