PAREXEL International Corporation has announced expanded evidence-based services for biopharmaceutical products. PAREXEL® Access focuses on clinical research and operations, market access consulting, medical communications, and pharmacovigilance to help companies identify, evaluate, generate and communicate the evidence of product value needed to successfully position a drug for market access and to support the product throughout its lifecycle.
It is estimated that the average cost to develop and gain marketing approval for a new prescription medicine, a process often lasting longer than a decade, is now $2.56 billion. To ensure a return on investment, the transition from clinical research and development to regulatory approval and commercial growth requires thorough data and specialized 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 the expertise of HERON™ Commercialization, QSI’s pharmacovigilance, PAREXEL Medical Communications, and PAREXEL Peri-/Post-approval services to offer a complete range of fully-integrated 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 our clients to make data-driven decisions to support reimbursement.
• Evidence Generation: Providing services to clients 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.
Schultz added, “By combining our deep experience, innovative strategies, and the industry’s best minds, PAREXEL Access offers an unrivalled team of experts located throughout the world to support our clients.”