PAREXEL International Corp. has expanded its evidence-based services for biopharmaceutical products with PAREXEL Access, which focuses on clinical research and operations, market access consulting, medical communications, and pharmacovigilance to help companies identify, evaluate, generate evidence of product value needed for market access and to support product lifecycle.
 
With the cost and time involved in developing and gaining marketing approval of a new drug, increasingly the transition from clinical R&D to regulatory approval and commercial growth requires thorough data and strategic expertise that integrates scientific and commercial insights. 
 
“No longer is demonstrating safety and efficacy enough to launch a product successfully. The pressures to control the cost of healthcare coupled with the development of payer oversight organizations mean drug developers must demonstrate clear value to add a product to the treatment landscape,” said Joshua Schultz, corporate vice president and worldwide head of PAREXEL Access, PAREXEL. 
 
PAREXEL Access combines HERON Commercialization, QSI’s pharmacovigilance, PAREXEL Medical Communications, and PAREXEL Peri-/Post-approval services to help clients position their products for market access and ongoing commercial success, including:
 
·      Evidence Identification and Evaluation: Aligning evidence generation and economic evaluation with pricing, reimbursement and market access strategy to enable clients to make data-driven decisions to support reimbursement.

·      Evidence Generation: Providing services to generate evidence of a product’s value through a range of global study types, including interventional trials, observational research, managed access programs, real-world evidence studies and drug safety programs.

·      Communication: Developing the best way to integrate complex scientific and economic data into insightful communications for key audiences, including payers, providers, patients, and policy makers.


Click here to read our Online Exclusive with Joshua Schultz