The Clinical Trial Industry at large is adjusting its operational procedures in response to the physical site access disruptions associated with the COVID pandemic. This emergent situation has compelled the industry to move away from its traditional onsite monitoring regimen and adopt an alternative remote monitoring approach.
Most of the clinical research sites maintain source documents and essential site master file (SMF) documents either on paper or on hard to access digital storage tools. This process hinders the work of CRAs who are now barred from visiting the clinical site and forced to work remotely. Because of the stringent regulations that bound the sharing of source documents and clinical trial regulatory files, utilization of generic non purpose- built file share systems, cloud- based folders, fax, or email platforms can introduce significant compliance risks. A well designed and secure remote source data verification (rSDV) application supports the immediate need for clinical sites and clinical research associates (CRAs) to continue working together while onsite visits have mostly become remote.
Why choose Octalsoft rSDV application?
To mitigate this risk of regulatory non-compliance while enabling remote collaboration, Octalsoft has introduced a 21 CFR Part 11, EU Annex 11, GDPR, and HIPAA compliant remote source data verification (rSDV) application. The Octalsoft rSDV module allows sponsors and CROs to maintain regulatory oversight of clinical sites by enabling remote access to study documents over a secure portal. It allows the users to remotely manage and track the workflow and downstream processes for source and study document review and verification.
Octalsoft has always been on the forefront to identify and implement the best solution for our customers’ projects to meet the regulatory, quality, and efficiency expectations. In current times when Risk Based Monitoring (RBM) and remote SDV are evolving into a standard model, our rSDV module is one such attempt at revolutionizing site monitoring by reducing the need for on-site SDV through secure file sharing and virtual collaboration.
