Non-interventional Studies
Successfully executing global studies to meet payer and regulator requirements
To achieve optimal market access and effectively commercialize a new therapy, you must demonstrate the effectiveness, safety and value of a treatment in a real-world setting. Robust study design, therapeutic area insights and expertise, patient and data access, and precision study execution are necessary components for study and program success.
We specialize in evidence, value and access. We combine a deep understanding of the peri- and post-approval environment with decades of experience in global product development, spanning early stage, product launch and post-approval evidence generation to meet the requirements of payers and regulators alike.
Over the past five years, we have conducted:
An evolving safety landscape
The long-term evaluation of the safety of regulated medical products in the real world is foundational to sustained patient access to novel therapies. 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 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 peri- and post-approval 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.
- Disease and product registries
- Burden of illness studies
- Long-term treatment durability and safety studies
- Risk evaluation and mitigation strategies (REMS)
- Risk management plans (RMPs)
- Post-authorization safety studies (PASS)
- Pregnancy and lactation studies
- Pharmacoepidemiology and drug utilization studies
- Phase IIIb-IV interventional studies
- Pragmatic trials
- Literature reviews and meta-analyses
- Patient preferences
- Quantitative risk benefit analysis
- Consulting on medical product safety across the life cycle
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 real-world, non-interventional study operations, regulatory and global clinical supply teams bring a wealth of knowledge and extensive experience to each project including:
- Teams across Europe, North America and Asia with more than 25 years of experience
- Specialist 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
