Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
Strategies and innovations related to how clinical professionals are utilizing technology internal and external to their organizations to advance clinical trials. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
ClinCapture 1.0.3 was designed to provide sponsor companies with an extensive and scalable solution to streamline their clinical trials. The system is being utilized on registry studies with more than 20,000 patients over 20 years. “ClinCapture 1.0.3 features an extended set of functions without start-up costs, license fees or vendor lock-in”, explains Ale Gicqueau, President & CEO at Clinovo.
With this new release, ClinCapture becomes the first open source Electronic Data Capture (EDC) system with an integrated randomization capability. Developed in collaboration with Randomize.net, the randomization function performs its role efficiently and seamlessly while preserving data integrity and patient safety. Critical patient data is encrypted throughout the randomization workflow. Randomization time and results are securely logged in the study audit log to ensure 21 CFR Part 11 compliance. The randomization function makes ClinCapture compatible with any clinical studies, involving block, stratified, single- or double-blinded randomization. The randomization function is currently utilized on clinical studies with up to 1,700 patients.
The new Calendared Events and Dynamic Groups functions were designed to automate error-prone and time-consuming processes to reduce overhead and accelerate the study conduct. The new Dynamic Groups function allows sponsor companies to create multiple treatment arms in ClinCapture. Subjects are automatically associated with events related to their treatment arm. The Calendared Events function allows users to automatically schedule events at the completion of a reference event. The function integrates automatic reminder emails when the calendared event is about to begin, and automated queries for missed events according to a pre-defined timeframe. The Calendared Events and Dynamic Groups functions reduce clinical teams’ overhead and streamline study conduct.
ClinCapture’s eClinical Suite extends ClinCapture’s capabilities and meets the needs of medical device and pharmaceutical companies looking to run early and late phase clinical trials or registry studies.