Helping our customers to generate the right evidence to make the best clinical decisions and maximize return on investment

We begin by understanding the purpose of the data and the need for a flexible approach with study designs, matched with technology and dedicated operational staff. Our experts design a study or program that will generate the required data to understand how a treatment, service or method of delivering care works when applied in real world, clinical practice environments. 

 

Our Process

We maximize value for you by providing consultative and operational expertise in Real World Data generation from concept through to commercialization. Building upon our 25 years of experience delivering studies globally, we have the people, processes and technology to design, plan, execute and deliver real world evidence for you, patients, physicians, payers and regulators. 

 

Fit for purpose solutions

At INC Research, we have a business unit dedicated to real world, evidence-based data collection.

For over 20 years, we’ve been conducting studies worldwide for phases IIIb/IV, including: observational studies, patient registries, post approval/authorization, Risk Evaluation and Mitigation Strategies (REMS), as well as health economics studies. 

Patient Registries

At INC Research, we continue to manage the longest-running pregnancy registry. That’s why we were invited by the FDA to present on pregnancy registry best practices and to participate as a panel expert at their forum on this topic.

Our dedicated group has experience across registry designs, products, diseases, and outcomes follow up.

We are best known for our pregnancy registry expertise; we have dominated this unique niche, and overcome many challenges from open-enrollment, integrating data from multiple healthcare providers, and complex subject-specific exposure assessments. Our registry best practices also extend to product and disease registries, where we have implemented several multi-national and multi-sponsor projects.

We have a long history of excellent interactions and negotiations with the Food and Drug Administration (FDA) on behalf of our Sponsors. Recognized as a leader in the industry, INC Research was the only CRO invited by the FDA to present on pregnancy registry best practice and participate as a panel expert at their forum, Study Approaches and Methods to Evaluate the Safety of Drugs and Biological Products During Pregnancy in the Post-approval Setting (May 28-29, 2014). INC Research provides efficient, scientifically rigorous registry programs that conform to FDA standards for conducting registry studies. In addition to the 2014 FDA forum, INC Research has worked directly and extensively with the FDA since 2002 in developing and refining their guidance document on pregnancy exposure registries. Our interaction with the FDA has not been limited to input on guidance documents, but also encompasses collaborative negotiation with sponsors and the FDA around pregnancy exposure registry design and reporting issues. INC Research is well positioned to leverage this tremendous experience in registry design, reporting, and FDA guidance to meet our sponsor needs.

As an industry leader in conducting pregnancy registries, INC Research Real World & Late Phase understands the unique challenges and benefits of conducting a registry as well as the fact that there is no one size fits all model.  Because of our unparalleled experience in this area, our group prides itself on working with our sponsors to understand the unique nature and scientific merits of each registry that we conduct. We have consistently shown the ability to adapt and customize our processes with regards to our registries to fit the needs of each of our customers and address the distinctive challenges that can occur. 

While each registry is different, our experience in this area has allowed us to create innovative solutions to many of the consistent challenges and obstacles our sponsors face.

Our Cross Functional Solutions

Discover more about our cross functional solutions, including our Strategy Consulting capabilities, by clicking here