Non-Interventional Studies

Successfully Executing Global Studies to Meet Payer and Regulator Requirements

Robust design, epidemiologic and therapeutic area insights, advanced data analytics and precision study execution are critical for study and program success.

As a business of PPD, we combine a deep understanding of the peri- and post-approval environment with decades of experience in medical and scientific strategy , spanning early stage, product launch and post-approval evidence generation to meet the requirements of payers and regulators alike.

Ready to Get Started

Over the Past Five Years, We Have:

Executed 70+ safety studies and registry programs executed

Conducted 50+ chart review studies across 12 therapeutic areas in 18+ countries

Supported 50+ drugs/therapies

Engaged with 116,000+ patients and 15,000+ sites globally

Optimized protocols of patient-centric study designs, endpoint selection, and statistical analyses

Enabled innovative technology and data-driven solutions including decentralized and virtual direct-to-patient or physician studies, ClinicaLive™, Preclarus, mHealth and eConsent

Provided access and insights to global real-world data sources enabling innovative real-world hybrid method study designs

An Evolving Safety Landscape

The evaluation of the long-term safety of regulated medical products and devices in the real world is foundational to sustained patient access to novel treatments. Recent advances in science, technology and the availability of real-world data sources, combined with an increased focus on drug safety have contributed to new and evolving regulatory and methodological frameworks to improve data-driven risk assessment and management, surveillance and the safe use of regulated medical products.

Our global multidisciplinary team of market access strategists, scientific, clinical and operational experts work with customers to create robust study designs and on-time study execution utilizing primary and/or secondary data. Our full suite of peri- and post-approval safety solutions are aligned with regulatory frameworks in the U.S. and Europe and can be customized to help you satisfy your evidence generation needs and requirements.

We Offer You

Disease, product, and pregnancy registries

Design and execution of global registries to evaluate specified outcomes for a population of interest

Learn about our pregnancy registries

Long-term treatment durability and safety studies

Multi-year, observational studies to understand the durability and safety of a product in the real-world

Risk Evaluation and Mitigation Strategies (REMS) & Risk Management Plans (RMPs)

Evaluation of the likelihood of receiving a REMS requirement, as well as the design, implementation, and assessment of single-sponsor and large, multi-sponsor REMS programs

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Chart Reviews and ClinicaLive™

Tailored, patient-level repositories of real-world data that can be supplemented over time as new sites and patients are recruited

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Post-authorization safety studies (PASS) / (PAES)

Design, delivery, and communication of safety studies and programs to help ensure safe and appropriate product use

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Virtual/Decentralized Studies

Placing patients at the center of a trial and allowing them to participate more easily to enable the collection of rich, real-world data

Read a Recent Case Study

Early natural history and screening studies

Collection of real-world data to track a disease’s progression to understand prevalence, demographics, changes in severity, outcomes, and more

Read our Recent White Paper

Customized Studies Designed by Dedicated Experts

Our experts provide the deep expertise and access to worldwide patient populations that are essential for real-world study success. Our dedicated, multi-disciplinary, real-world, non-interventional study experts bring a wealth of knowledge and extensive experience to each project including:

Teams across Europe, North America and Asia with over 25 years of experience
Specialist and dedicated medical affairs team that exceeds industry benchmarks in study startup and patient recruitment time
Experience in most therapeutic areas and capabilities across a wide range of indications with extensive experience in pain/opioids, oncology, cardiovascular disease and ophthalmology
Expertise in study design, protocol development and optimization, with all studies governed by a scientifically robust protocol that is reviewed and quality controlled by an in-house, industry-recognized research team
Team of data scientists with a deep understanding of, and experience with, data sources from more than 20+ countries including in North America and Europe, and other regions as needed to create hybrid studies