eCRF

Integra IT’s eCRF and Data Management Services, powered by the Viedoc EDC platform, present a robust and scalable solution for clinical trial data collection and management that is particularly well-suited for mid-sized Contract Research Organizations (CROs) and sponsors operating in emerging markets. This cloud-based system is designed to streamline the entire lifecycle of clinical data—from designing electronic Case Report Forms (eCRFs) to ensuring high data quality, facilitating seamless collaboration, and accelerating study timelines. One of the platform’s notable strengths is its adherence to international standards such as CDASH and SDTM, which enhances data consistency and regulatory compliance. The user-friendly interface allows study teams to build and manage eCRFs efficiently, reducing the learning curve and operational overhead. The integration of automated query validation and real-time monitoring tools enables proactive data quality management by quickly identifying and resolving discrepancies. This, combined with comprehensive audit trails, strengthens data integrity and ensures transparency for regulatory inspections. Moreover, the system supports standardized medical coding for adverse events using recognized dictionaries like MedDRA and WHO-DD, further contributing to data standardization and facilitating regulatory submissions.