Company's FasTrac™ Chart Review to Accelerate Clinical Trial
Recruitment for Pivotal Phase III Study
Atlanta, GA,
June 24, 2002 -- MDdatacor, inc., a medical informatics company that rapidly identifies patient populations for clinical trials, approved therapeutics and medical devices, today announced it reached agreement with a pharmaceutical company to use MDdatacor's FasTrac™ Chart Review (FasTrac) clinical trial screening and recruitment solution. The pharmaceutical industry contract, signed under non-disclosure, calls for MDdatacor to provide its technology solution to a number of the pharmaceutical company's investigator sites for an ongoing Phase III clinical trial.
FasTrac allows trial sponsors and clinical research organizations to accelerate Phase III and Phase IV trial recruitment by identifying patients within an investigator's clinical practice that meet the protocol's inclusion and exclusion criteria. Rather than taking months to enroll patients through traditional methods, FasTrac enables investigative sites to identify qualified trial candidates in minutes, reducing the time necessary to complete patient enrollment.
"This contract further validates our belief that FasTrac offers trial sponsors and clinical research organizations many advantages over other patient recruitment and screening methods," commented Blake Whitney, MDdatacor chairman, president and chief executive officer. "Ultimately, FasTrac saves the trial sponsor both time and money by greatly compressing the clinical trial patient recruitment process."
FasTrac Offers Technology-Based Trial Recruitment Alternative
FasTrac replaces manual chart audits and other traditional clinical trial recruitment methodologies, such as direct-to-consumer media advertising. MDdatacor partners with specialty physician practices that provide MDdatacor with electronic copies of their patient medical information. Utilizing a patent-pending process, MDdatacor creates a clinical database from this information and mines it using proprietary search technology.
With FasTrac, a trial sponsor or clinical research organization provides MDdatacor with the trial protocol. MDdatacor creates a database search using the protocol's inclusion and exclusion criteria which is then run against patient data from the sponsor's clinical sites. A list of patients who meet the trial criteria is presented back to authorized personnel at each site for follow-up by their research staff.
"We have an active research department and it can be difficult satisfying patient recruitment goals for our many ongoing clinical trials. By utilizing FasTrac, my research staff can reduce our 10,000 active patient charts to the 30 or 40 patients who are eligible to participate in a particular study," commented Paul Seigel, M.D., managing partner at the Miami Cardiology Group. "This service saves us a tremendous amount of time and greatly increases my staff's productivity, enabling us to participate in more trials than we could previously. Our patients also appreciate being notified about ongoing studies, since it may provide them with early access to promising new medical therapies."
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