As the use of technology continues to increase within clinical trials, it is important for CROs to be able to offer technological solutions to their clients while also leveraging technology in their everyday work to become more cost-effective. Montrium has been working closely with CRO clients to develop tools which allow them to add value to their existing services. Notably, we have developed multi-sponsor environments for the management of the eTMF and regulatory documents. CROs can collaborate externally with sites, sponsors and other stakeholders to centrally create, collate and manage eTMF and regulatory records. These records are available to sponsors at all times, helping them better understand and manage their clinical programs or regulatory submissions. Inspection readiness is also key and we have built tools which facilitate the navigation of records during audits and inspections, helping both the CROs and sponsors to always be in compliance.
Finally, we are able to provide a fully integrated online quality management system which improves compliance with SOPs and training and allows CROs to proactively manage quality while minimizing the cost of quality and adding true value to clinical quality management.