A clinical trial’s ability to succeed is mainly dependent on the case report forms that are used. Our eCRF Management module can aid with CRF design in this situation. Additionally, it can be programmed to run real-time validation checks, allowing for the efficient collection of complete, dependable, and correct data in accordance with regulatory standards.
The Source Data Verification (SDV) procedure, which guarantees data quality and compliance to source data, is a crucial component of clinical data management. Instead of 100% SDV for all patients, this selective feature concentrates on confirming important research data points, which saves time, effort, and money while retaining the trial’s scientific and ethical integrity.
To ensure that the system captures accurate and reliable data, our Discrepancy Management tool assists investigation sites in locating and managing data aberrations. The data export function of our application provides standard and configurable dataset exports in.CSV and.XLS formats at any moment, including during the research run, for intermediate and final detailed analysis.
Every clinical trial’s central tenet is patient safety, thus it’s critical that AEs and SAEs are promptly reported to relevant parties and regulatory agencies and addressed appropriately. Users are alerted about AE/SAE reporting activities thanks to our functionality that offers automatic notifications sent through email.
You can streamline your coding process with the aid of our built-in coding interface and the real-time data made available by our EDC system. We can ensure accurate and consistent coding of verbatim terms to harmonised and standard codes thanks to the usage of standard medical dictionaries like MedDRA and WHO-Drug Global in our integrated coding mechanism.