Research phase of large scale investigator-initiated study conducted across multiple clinical sites successfully completed 79% faster
May 1, 2008 / Research Triangle Park, NC — Clinipace, a growing on-demand clinical research software company, announces the successful completion of a large-scale, investigator-initiated study powered by TEMPO – the company’s Web-based clinical research software — conducted at Carolinas Medical Center in Charlotte, North Carolina.
Andrew Asimos, MD, Director of Emergency Stroke Care at Carolinas Medical Center in Charlotte, NC and site investigator for the North Carolina Collaborative Stroke Registry (NCCSR), recognized that the registry could serve as the backbone for additional research—particularly on patients who have a Transient Ischemic Attack (TIA), also called a mini-stroke. Dr. Asimos wanted to validate guidelines for risk -stratifying patients who experience a TIA that purport to predict whether these patients would go on to have a full-fledged stroke in the short term.
Because the North Carolina Collaborative Stroke Registry was already a customer of Clinipace, Dr. Asimos approached the company to use its Tempo platform to conduct his research. According to Dr. Asimos, “Clinipace was extremely accommodating from a budget, regulatory, and deadline standpoint. I needed to recruit 1,500 to 2,000 patients, so identifying hospitals with large numbers of eligible patientswas imperative. With Clinipace’s research software platform in use within the NCCSR, finding the right hospitals to participate in the study took minutes, not months. The reporting engine within Tempo made patient recruitment straight-forward and easy to manage.”
Dr. Asimos ultimately lined up 16 North Carolina hospitals to participate in his research. Clinipace offered the perfect solution for managing a geographically dispersed research project that relied on hospital sites to collect information within the emergency department. The software had to be simple for the busy data collection personnel at each site; otherwise the project would have failed. “In this way, Clinipace allowed me to easily manage the project without creating a burden for our hospital sites,” said Dr. Asimos.”
Dr. Asimos explains, “I would have never been able to do a project this ambitious within my budget without Clinipace. For a study of this magnitude, data collection and analysis on paper would have totally undermined the project, not to mention my ability to monitor the progress of the study, patient recruitment, and the status of data collection. As a result of our collaboration I was able to significantly reduce the time it would have taken to identify sites and eligible patients by mining the registry data. In the end, the time needed to complete the research phase was reduced to 7.5 months – a 79% savings in time to database lock. Without the collaboration a similar project would have taken me 3 years. Clinipace also deeply understands the regulatory environment of academic research which helped me tremendously as I prepared and conducted this research.“
Jeff Williams, Chief Executive Officer of Clinipace, added, “We pride ourselves on being creative thinkers and problem solvers, and this project is a perfect example of the flexibility our software platform affords our customers. Dr. Asimos and his team were able to complete the site recruitment and data collection phases of his research much faster than they could have otherwise and without having to worry about infrastructure and software complexity. Our team is fanatical about helping our customers achieve their research objectives and we jumped at the chance to support this investigator-initiated project. Academic-based investigators want to conduct research, not worry about software, and Tempo is ideally suited for this environment.”
Currently, the research phase of the project is complete and the data are being analyzed at the University of North Carolina, Department of Epidemiology within the School of Public Health.
Clinipace is a clinical research software company providing a single, integrated data capture and study management platform for post-approval research and registries conducted by biopharmaceutical and medical device companies, Clinical Research Organizations (CROs) and Academic Medical Centers (AMCs). Our platform, called Tempo, is delivered via a web-based, on-demand architecture that streamlines the clinical research process by eliminating the integration headaches associated with multiple platforms, reducing project efforts and costs from startup to conclusion, and empowering project stakeholders to make informed real-time decisions regarding their research. For more information on Clinipace, please visit: www.clinipace.com
About Carolinas Healthcare System
Carolinas HealthCare System (www.carolinashealthcare.org) is the largest healthcare system in the Carolinas, and the third largest public healthcare system in the nation. Its flagship facility is Carolinas Medical Center (www.carolinasmedicalcenter.org) in Charlotte, an 874-bed hospital which includes a Level I Trauma Center, a research institute and a large number of specialty treatment units. CMC also serves as one of North Carolina’s five Academic Medical Center Teaching Hospitals, providing residency training for over 200 physicians in 15 specialties. CMC is listed as a “Best Hospital” by U.S. News & World Report for urology and orthopedics, and has been designated 10 times as Charlotte’s “Consumer’s Choice Preferred Hospital” by the National Research Corporation. HealthGrades, a leading healthcare ratings company, named CMC-NorthEast “The Best Hospital in North Carolina” for cardiac services.