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Peri- and Post-Approval Services

Optimized patient access requires strong evidence of value, effectiveness and safety

Biopharmaceutical companies are needing more and more evidence to prove value and effectiveness in post-approval settings, including how to communicate this evidence to payers, health authorities and other decision-makers.

  • Does the treatment improve patient outcomes and is it safe in the real world?
  • Which patients will most benefit from the treatment?
  • Is the treatment worth the price paid and does it deliver good value for the price?  

Questions like these are just the tip of the iceberg when bringing a pharmaceutical, biotech or medical device product to market. Translating favorable pre-approval clinical trial results into success in the real world can be one of the most daunting parts of the product development process. Although the industry continues to witness advancements in analytical methods and technologies, gain greater access to novel data sources and develop new approaches to harness patient preferences and insight, the payer and regulatory evidence requirements are expanding. These stakeholders are seeking ever-increasing insight into the real-world impact and overall value of a product to both individual patients and the health care system at large. 

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Peer-reviewed publications per year

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Global payer submissions supported per year

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Therapies per year where PPD has helped generate evidence to demonstrate safety, effectiveness and value

INFLUENCE

Developed evidence to reverse, fast-track and influence National Institute for Clinical Excellence (NICE) decisions across a variety of therapeutic areas

The Right Expertise for the Right Evidence

Evidera PPD logo

Evidera, PPD’s dedicated peri- and post-approval business, works across the full development continuum with you to build and communicate the right evidence package for your product. By identifying potential gaps in your product development program and mapping the relevant evidentiary requirements and hurdles, we can help shape and deliver the strongest possible peri- and post-approval evidence plan for the critical journey toward commercial success. With more than 30 years of experience working with payers and health authorities, our 700+ scientists, consultants and operations professionals have supported a range of products across nearly every therapeutic area and in most major markets around the world.

A track record of success

We have a proven track record of generating high quality research that has impacted access decisions and helped to put treatments in the hands of patients.

Our pioneering research methods and study types are able to:
Improve the likelihood of clinical trial success
  • Simulate impact of changes to sample size and duration on potential outcomes through modeling and advanced statistical methods
  • Create synthetic control arms when placebo is not logistically, financially, or humanistically possible
Influence payers/HTAs with robust evidence of effectiveness, safety and value
  • Contributed to 130+ payer submissions across 20+ countries in the past five years
  • Developed evidence to reverse, fast-track and influence NICE decisions
  • Authored 2,200+ peer-reviewed publications, averaging 130+ per year
Harness patient voice through industry leading PRO/COA and patient engagement solutions
  • Engaging patient advocacy groups to include patient advisors in clinical trial planning
  • Developed/validated 100+ PROs/COAs; 15 have achieved product labeling claims
  • Developed the firstsecond, third and fourth PRO/COA instruments to receive qualification statements from the FDA/EMA
Identify new and unique approaches to demonstrate value

OUR SOLUTIONS

Interventional Studies

  • Phase IIIb-IV studies
  • Expanded access/compassionate use programs (EAP/CUP)
  • Extended access programs (XAP)/Open label extensions (OLE)
  • Lactation/placental transfer studies
  • Pragmatic/adaptive trials
  • Investigator sponsored/initiated trials (IST/IIT)

Data and Real-World Evidence

  • Database analytics
  • Social media analyses 
  • Hybrid database and direct-to-patient studies
  • Advanced statistical modeling, predictive analytics and machine learning approaches
  • Post hoc and exploratory analytics of trial and observational data
  • Coding algorithm development

Non-Interventional Studies

  • Registries (disease, product, pregnancy)
  • Post-authorization safety and efficacy studies (PASS and PAES)
  • Patient or physician surveys
  • Medical chart review studies (EMR and prospective)
  • Risk evaluation and mitigation strategy (REMS) programs and risk management plans (RMPs)
  • Time and motion studies

Evidence Synthesis, Modeling and Communication

  • Economic and epidemiological modeling
  • Clinical trial and disease simulation
  • Indirect treatment comparisons
  • Systematic and targeted literature reviews
  • Dossiers, value stories and submission support

learn more about Evidera’s peri- and post-approval service offerings

Access Insight from Evidera experts

Our researchers are prolific producers of scientific content. Browse Evidera’s library of white papers, webinars, fact sheets and issues of our biannual publication, The Evidence Forum.

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