Pharmaceutical Product Development (PPD), based in Wilmington, N.C., and HealthCore, based in Wilmington, Del., are collaborating to further expand their services in the pre- and post-approval research market with the aim of helping biopharmaceutical clients demonstrate more quickly and cost effectively how their products will perform and benefit patients in the real world.

The collaboration brings together two well-respected organizations and aligns complementary strengths to address the need for real-world evidence, one of the faster-growing aspects of clinical research. It combines PPD’s clinical trial design, health economics and outcomes research (HEOR), medical affairs research and epidemiology services with HealthCore’s strengths in HEOR, innovative real-world research designs and its robust research-enabled electronic health care data environment.

“The goals of optimizing reimbursement and increasing payer and patient value are becoming more dependent on biopharmaceutical companies’ ability to provide high-quality evidence of how products will perform for patients in a real-world setting,” said Michael Pollock, vice president of real-world outcomes at PPD. “With the collaborative expertise of PPD and HealthCore, particularly in planning, designing and implementing pragmatic clinical trials, we hope to set a new standard for the quality, cost and speed of real-world evidence generation that can help optimize patient outcomes and enable our clients to better demonstrate the true value of their products and the return on their investments in new product development.”

The collaboration allows life sciences companies to engage in one contract with combined services from PPD and HealthCore that has the potential to cover product research in both pre- and post- approval settings. Both PPD and HealthCore will be able to provide biopharmaceutical companies analyses of medical claims data and electronic health records necessary to understand the utilization and impact of their products and to design appropriate pragmatic clinical trials that address payers’ needs.

“By combining clinical and economic information and leveraging our access to large health care provider networks, we will have a much more robust view of how patients use and react to different therapies,” said Marcus Wilson, president of HealthCore. “This gives us an opportunity to produce relevant information that can facilitate decisions and speed to market those products that provide the most value to patients, payers and life sciences companies alike.”

The majority of post-approval pharmaceutical research includes HEOR, as life sciences companies seek to generate real-world outcomes as part of their cost-effectiveness analyses. Payers are requesting more real-world evidence to help them analyze product safety and effectiveness. As a result, companies are undertaking more pragmatic clinical trials and other phase IV studies to meet the payer need for real-world outcomes data and to support appropriate reimbursement.

“There’s a certain level of efficiency and understanding that the two companies will gain from working together on research designs at an earlier point in the development process,” said Mark Cziraky, vice president of research for HealthCore. “This approach allows us to evolve the evidence while operationally offering seamless, one-stop research shopping to life sciences companies.”