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.
Peer-reviewed publications per year
Global payer submissions supported per year
Therapies per year where PPD has helped generate evidence to demonstrate safety, effectiveness and value
Developed evidence to reverse, fast-track and influence National Institute for Clinical Excellence (NICE) decisions across a variety of therapeutic areas
Forward. Faster. Further.
Today’s world of drug development is constantly changing. With an increase in patient engagement and empowerment, a rise in new real-world data sources and a shifting stakeholder and regulatory landscape, you need a way to break through the chaos to find clarity so patients can get what they need.
Evidera, PPD’s dedicated peri- and post-approval business, brings together innovative methodologies, cutting-edge technologies and unparalleled experts with a passion for creating solutions. With over 35 years of scientific rigor and operational expertise, we can help you take on Phase I to post-launch with unmatched efficiency and speed. Ready to move your product forward?
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.
- 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
- 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
- Leading an IMPACT HTA work package to create guidance on the combination of RCT results with RWE (observational, registry) in economic evaluation
- First CRO to join MIT’s NEWDIGS initiative as a strategic partner
- First successful implementation of a real-world data collection framework add-on to an Early Access to Medicines Schemes (EAMS) program
- Phase IIIb-IV studies
- Expanded Access and Post-Trial Access Programs (EAP/PTAP)
- Open-Label Extension (OLE) and Rollover Studies
- Lactation/placental transfer studies
- Pragmatic/adaptive trials
- Investigator sponsored/initiated trials (IST/IIT)
- 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
- 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.