Supporting Product Approval
Planning for Approval
With rigorous and evolving payer evaluation criteria, challenging price negotiations and a dynamic competitive environment, manufacturers need to prepare their market access strategy early in the product life cycle and assess often to ensure optimal access.
At Evidera, PPD’s peri- and post-approval business, our global teams of industry leaders, former payers, policy experts, physicians and experienced strategists can help you navigate complex evidence requirements and anticipate and overcome payer barriers to achieve optimal price and access.
From synthesizing evidence, to modeling unobserved outcomes, to defining and communicating your product’s value story, we can help demonstrate the value of your product to a host of stakeholders.
products/therapies supported in the past year with peri- and post-approval research
payer submissions across 20+ countries in the past five years
developed evidence to reverse, fast-track and influence National Institute for Clinical Excellence (NICE) decisions across a variety of therapeutic areas
UNDERSTANDING THE PATIENT PERSPECTIVE
We incorporate the patient experience – their perspectives, preferences and insight – into key aspects of your research. From designing protocols, to enrollment and retention, to evaluating health outcomes, patient-centric data and information are essential to product development and approval, and ultimately, to a healthier world.
Our patient-centered experts span a variety of disciplines, including psychometrics, economics, decision analysis, epidemiology, biostatistics, psychology and public health, and can help answer your most challenging research questions. By engaging with patients and patient groups, we can illuminate the patient experience at various stages in your product’s life cycle and better inform your patient-focused drug development strategy.
With the rising cost of health care and access to more data than ever before, payers and health authorities have increased their expectations, demanding more and better evidence of a product’s value, safety and effectiveness. Real-world evidence is becoming increasingly important for product market access.
Our researchers have experience with over 100 data sources across more than 20 countries in North America, Europe, South America and Asia, as well as several data partnerships, to extract deep insight from real-world data. When suitable data sources are not available or inadequate, we can design and execute prospective data collection, hybrid or direct-to-patient studies, that result in tailored, fit-for-purpose data to help ensure you’re making decisions, not assumptions.
PPD is a leader in generating and communicating evidence of a product’s value. We can help you pinpoint the data you need, build your evidence generation strategy and ensure you’re never making assumptions when making decisions.
If you’re planning your market entry – and you should begin as early as Phase II – partner with PPD to synthesize evidence in ways that will convey a compelling value story to regulators and payers.”
Peri- and Post-approval
Can help you optimize patient access with evidence of product value, effectiveness and safety.