two women reviewing documents together

Supporting Product Approval

Erem Latif
Erem Latif
“Your goals are clear: Reach product approval, establish market access, attain favorable positioning and do all three as quickly as possible. But without proper downstream insight, the path to realizing these goals is often vague in early development.

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.”

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.

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products/therapies supported in the past year with peri- and post-approval research

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payer submissions across 20+ countries in the past five years

influence

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.

REAL-WORLD EVIDENCE

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.

Peri- and Post-approval

Can help you optimize patient access with evidence of product value, effectiveness and safety.