The Innovative EDC tool with agile methodologies allows users to quickly setup and configure study database, design Case Report Forms with programmed Edit Checks to collect high quality, accurate clinical data and extract submission-ready standardized datasets all through an easy-to-use web-based graphical user interface.
The success of a clinical trial depends largely on well-designed Case Report Forms. The eCRF Management module helps design eCRFs and program real-time validation checks to operate the forms in an efficient way to collect complete, reliable, and accurate data as per the regulatory standards.
A key aspect in clinical data management, the SDV process ensures data quality and conformance to source data. The selective SDV feature focuses on verifying critical study data points instead of 100% SDV for all patients. Thus, saving time, effort, and costs while maintaining the scientific and ethical integrity of the trial.
The Discrepancy Management tool helps investigation sites identify and manage discrepant data to ensure that clean and consistent data is captured in the system. The data export feature of the tool fosters standard and customizable dataset exports in .CSV and .XLS format at any time during the conduct of the study for interim and final comprehensive analysis.
Streamline your coding process using the built-in coding interface with the real-time data available from the electronic data capture system. Precise and consistent coding of verbatim terms to harmonized and standard codes is guaranteed with the integrated coding mechanism using standard medical dictionaries MedDRA and WHO-Drug Global.
Patient safety being the fundamental principle at the core of every clinical trial it is important that the AE/SAEs are timely reported to stakeholders and regulatory bodies and handled appropriately. Automatic notifications triggered via email keeps users informed on AE/SAE reporting actions.