We have over 20 years’ experience performing late phase studies. In the past five years alone, INC Research has supported over 70 studies globally across more than 30 countries, 35 unique indications and various study designs. From those studies, we’ve collected data on 100,000 patients across 8,000 sites. We also continue to manage the longest-running pregnancy registry.

See what sets INC Research apart conducting late phase studies

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 - but not limited to -observational studies, patient registries, post approval/authorization, Risk Evaluation and Mitigation Strategies (REMS), as well as health economics studies. 

We have evolved to meet the growing requirements for evidence-based, patient-centered outcomes in order to offer a stronger complement to our therapeutically-focused business units, and grown a fit-for-purpose internal infrastructure to meet the unique needs of sites, patients, and our customers.

Our internal infrastructure, processes and technology were established to meet the unique demands of customers, sites, patients, and project teams. We bring together processes, technology and people in a way that demonstrates market understanding as well as effective delivery of observational research through INC’s Trusted Process®.

 

Our Extensive Late Phase Experience

We are an industry leader in conducting safety surveillance and other observational studies. We can help with anything from Patient Reported Outcomes to the incorporation of economic questions into observational studies; and our operational proficiency and data-based decision making processes enable our customers to consistently realize study goals on time and on budget.
 
We understand that Late Phase research is a unique classification of the clinical research continuum based on real world evidence based data collection and reporting. We utilize an integrated approach, leveraging our dedicated therapeutic business unit expertise to support our Late Phase, fit-for-purpose operations.
 
We know that each project will be unique by design, deliverables, and regions where the studies will be performed. These projects could include those mandated by country-specific regulatory agencies, performed as part of an updated drug dosing or indication submission, part of a publication plan, non-site based patient registries, health economics focused, or biomarker sample collection to better prognosticate or diagnose a specific indication. The ‘why’ can vary greatly, and we are here to help improve health around the world. Our experience includes, but is not limited to, the following:

Our Process

An integral component of the Late Phase model is our epidemiology expertise, with extensive experience in the design, conduct and evaluation of epidemiological programs across a broad range of therapeutic indications and study settings.

We combine operational excellence with a strong scientific foundation and rigorous processes to ensure validity of study results by developing epidemiologically sound study designs and study procedures. We support our customer right from the start by providing strategic study planning, developing the study design and protocol, and instrument selection when applicable.

Our dedicated Late Phase business unit is led by experts in the field, and founded on core targeted Standard Operating Procedures (SOPs), guidelines, and study plans to efficiently and effectively conduct observational research.

Our Late Phase model was established to best address this evolving space and support our sites and partners.  This model is built on flexibility and the right-touch approach to centralized site support and on-site monitoring.  As healthcare costs continue to rise world-wide, it’s essential that we continue to support existing requirements with strategies and efficiencies in place. The utilization of strategic data monitoring and reducing the amount of data being source data verified has been performed within Late Phase research for years. We have the experience and systems in place to assess what is needed and implement the appropriate strategy to support study objectives, complexity, and design, with the flexibility to allow for modifications as data trends are analyzed.

Maintaining Site Relationships

We understand the many daily challenges physicians and research staff face to participate in clinical research, patient treatment, advocacy, insurance, and numerous other additional duties. Maintaining site relationships for Late Phase research is a layered approach that starts with finding the right sites with the necessary experience and patient population, collecting only the required essential documents, and then working with dedicated in-house site support that is trained and assigned to each study and participating site.

This relationship is proven to help sites better identify eligible patients, mitigate potential deviations, and reduce time spent addressing Electronic Data Capture (EDC) system queries, to deliver clean data. For more information on how we support sites, click here.

Fit for purpose solutions

With the continued evolution of technology, management of carbon copy case report forms (CRFs) is nearly extinct. The patient data associated with Late Phase research can come from study related visits, routine clinical consultations with their physician, and information collected via patient telephone interviews, or directly reported by patients into diaries, web-based systems, and tablets or personal smart phones.

Having flexible, streamlined, user-friendly Late Phase tailored systems is a must for real-world application to get the data we need, with data management and clinical team support to ensure that we maintain a positive experience for sites and patients.

Here at INC Research, we understand this paradigm and the importance of having a fit for purpose EDC System when conducting observational research. We have experience working across multiple platforms, and recently partnered with a dedicated Late Phase service provider that specializes in right fit solutions to manage observational studies. The system features include flexible visit schedules, sophisticated data cleaning, real-time query resolution, multi-lingual capabilities, and numerous other components that make it easy to use and intuitive for sites and team members.  All of this means that we can reduce site burden, motivate sites to enter data on time, and achieve high quality data without frequent on-site monitoring.

Our Patient Registry Experience

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

We are known for our pregnancy registry expertise. Our teams have 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.

For more information on how our experience in registry oversight helps us deliver best practice globally to support patient outcomes, please click here.

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 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 Global Registry Model

INC Research Late Phase has a large footprint in global registries and we have employed several global models with great success. Many of our registries have used the National Coordinator model to achieve results. Under this registry design, the INC Research Coordinating Center serves as the global management body who oversees the day to day operations of the registry, data management, analysis, reporting, and facilitation of an advisory committee. Each country outside of the U.S. has their own national coordinator that is contributing data to the Global Registry. The responsibilities of the National Coordinator include the facilitation of patient enrollment, the collection of data from reporters and the transfer of data to the central registry coordinating center.

Additional responsibilities can include the management of country specific regulatory requirements and data protection considerations. Additionally, the Late Phase group utilizes dedicated international phone numbers and fax lines to facilitate data collection in countries outside of the U.S. on current and past registries.

Patient and Healthcare Provider Awareness

Targeted awareness is a key approach to increasing enrollment in a registry. INC Research Late Phase has proposed, designed and managed many different awareness strategies tailored to reach the target populations of our pregnancy registries. Some of these initiatives have included:

  • Management of the design and distribution of study specific brochures, posters, pregnancy wheels and information sheets to pharmacies, clinics and targeted healthcare provider offices
  • Presentations at global conferences
  • Implementation and ongoing monitoring of internet search engine optimization tools
  • Website design, including redesign of existing registry websites to make them more accessible through videos, questions and answers, and having enrollment and participant consent forms available for download
  • Facebook and YouTube awareness options