21CFR-11, HIPAA, AND GDPR COMPLIANT
Services tailored to privacy concerns for each country
Our method maintains complete subject anonymity while detecting even those professionals who alter their presentation.
We provide the entire history of past study participation and a personalized investigation of actionable matches.
CTSdatabase Statement of Mission and Quality
CTSdatabase is implemented at the site level where it is used to detect duplicate subjects during pre-screening, as well as on the study level, where it is performed alongside screening procedures. We also integrate directly with IRT as a single-step check for your subject’s eligibility.
A 29-year-old woman with a history of screening for multiple Bipolar studies in Southern California screened for an MDD study at a site. CTS reported the subject’s past study participation history to the PI. The PI felt that in his clinical opinion the subject does not seem to be a “professional patient.”
That same day the subject presented to another site attempting to screen for an Anxiety study.
Publications and Presentations
The Patient in Your AD Study May be in Another: Duplication and Deception in Clinical Trials of Alzheimer’s Disease
The Journal of Prevention of Alzheimer's Disease, 2019 Discusses the rate of duplication in professional AD subjects, and offers findings on new indications these AD subjects present with at matching sites.
The Journal of Clinical Pharmacology, 2016 Highlights the importance of eliminating inappropriate subjects to ensure successful clinical trials, as well as how nonadherence can increase variance, lower study power, and reduce the magnitude of treatment effects.
Innovations in Clinical Neuroscience, 2013 Demonstrates the efficacy of CTSdatabase as a prescreening measure to reduce the number of duplicate and professional subjects entering clinical trials at CNS sites.
Give Us Your Tired, Your Poor, Your Professional Subjects: The Last Quartile of Phase 3 Enrollment
ASCP - American Society for Clinical Pathology, 2019 Introduces research suggesting that the subjects entered into the latter part of Phase 3 studies are more likely inappropriate (duplicate/professional) than in Phase 2 and Early Phase 3 studies.
American Headache Society, 2019 Explores how safety and efficacy signals in clinical trials may be adversely affected by professional Migraine subjects.