Quintiles, the market-leading contract research organization (CRO) and Cerner, a global supplier of healthcare solutions and electronic health record (EHR) technology, signed an agreement that will provide biopharmaceutical sponsors with research and technology services for improving post-marketing research.
Regulators and payers are increasingly calling for more post-marketing research, particularly observational studies and registries. CROs like Quintiles have been doing this type of research for some time and are looking to get a piece of the funding for comparative effectiveness research (CER). The American Recovery and Reinvestment Act, signed into law in February, includes $1.1 billion for CER.
Creating CER data infrastructure could offer major opportunities to technology companies such as Cerner and also to organizations that establish data standards. The creation of CER data infrastructure would include not only the development, building and maintenance of data infrastructure, systems or tools, but also the creation of new research data sets and repositories, aggregation of existing data sources, development of new tools to query and analyze exiting data sets, or creation of standards for new data collection.
Late phase research studies offer opportunities to establish long-term product safety, pursue expanded indications for use and strengthen the understanding of a product’s short-term and long-term value.
“Through Quintiles’ collaboration with Cerner, we now can offer biopharmaceutical organizations an integrated solution for conducting patient registries, post-approval and late phase studies, observational studies, and studies to support Risk Evaluation and Mitigation Strategies (REMS),” said Dr. Dipti Amin, Quintiles’ senior vice president of Drug Safety and Medical Affairs. “This then marries our clinical study design and operations expertise with their technical depth and understanding of clinical workflows.”
To help cost-effectively manage the data associated with this research, Quintiles will use the Cerner Discovere Late Phase solution designed to deliver an integrated study management solution.
The web-based platform will allow researchers to: gain a clearer picture of how a product is performing in the real world by easily integrating data from consenting study participants and site researchers; accelerate study startup and implementation through intuitive data collection workflow and the ability to pre-populate electronic case report forms (eCRFs); and increase data quality by reducing transcription errors.
“Cerner’s long-standing expertise in automating processes for healthcare organizations makes us uniquely suited to help Quintiles efficiently manage the vast amounts of data associated with late phase research,” said Mark Hoffman, Ph.D, Cerner’s vice president of Life Sciences. “The Cerner Discovere Late Phase platform reduces the time required to start late phase studies, provides sites with an easy-to-use system for compiling data and expedites reporting of valuable data back to Quintiles, sponsors and regulators.”
The Cerner Discovere Late Phase solution streamlines study build and reduces the time associated with study startup. Once research participants are consented and enrolled in a study, site research personnel enter data directly into the online form or review the data relevant to research that has been electronically populated from a participant’s EHR.