Electronic data capture for clinical studies - eCRF Ready

Data quality, speed and ease of data collection, ability to monitor, trace and audit trail with improved regulatory compliance are key for the digital transformation of the data collection process in clinical studies. CoLAB TRIALS has in-house expertise on developing eletronic Case Report Forms (eCRF), enabling higher data quality and a more efficient and standardized process of collecting scientific and clinical evidence. This service is directed to EIC Transition and EIC Accelerator, innovators that will perform clinical studies and clinical trials with health products/services/methods, ex: Medical Devices (including SaMD and IVD), New Approach Methodologies (NAMs including Biomarkers), and Medicinal products (including Pharmaceuticals and Advanced Therapy Medicinal Products). This service will be designed to meet the specific needs of health innovators. The goal of the service is to deliver a user-friendly tool for the collection of appropriate and robust scientific and clinical evidence during clinical studies, aligned with the ethical guidelines and regulatory requirements (Good Clinical Practices, CTR, MDR, IVDR, GDPR). The service of electronic data capture includes: eCRF development, data collection workflow and parametrization, user roles definition, development of rules specific to the clinical study/trial, data maintenance, audit trail. In the end of the service, EIC beneficiaries and innovators will be able to access a user-friendly and GDPR compliant tool for tailored data collection during the conduct of their clinical studies/trials.