As clinical trial sponsors seek to transform their operations, interactions with clinical trial sites and related document processes have increasingly moved into the spotlight as areas where change is needed.
- Traditional site documentation interactions are time and resource intensive. Site monitors physically visit a site, collect documents, and mail paper or scan/email electronic documents to sponsors. This costly process often results in duplicate or triplicate documents and is prone to errors.
- Site TMF documentation is a regulatory compliance issue. The risk of noncompliance is significant and can impact the progress of the trial.
- Many sponsors have chosen to implement document sharing technologies that offer greater transparency into site documents. However, these same sponsors often underestimate the change management aspects of implementing a new technology and process at clinical trial sites.
Collaborative Documentation for Clinical Trials
As with any process transformation, the effort to improve site TMF documentation processes requires a focus on organizational change management.
- New processes must be designed and documented to ensure consistency.
- Site staff must be trained on the new process, collaborative technologies, and all relevant compliance requirements.
- Support and issue escalation procedures must be instituted to ensure adoption of new processes and technologies and continued process integrity over time.
A collaborative approach to trial documentation offers greater transparency into evolving site TMF document collections. It also improves compliance and operational efficiency and decreases costs. Improved communications among sponsors, CROs, and site staff also simplifies the on-and offboarding of sites.
Collaboration and Transperancy
A collaborative approach to trial documentation offers greater transparency into evolving site TMF document collections. It also improves compliance and operational efficiency and decreases costs. Improved communications among sponsors, CROs, and site staff also simplifies the on-and offboarding of sites.
NNIT Solutions
The NNIT team understands the complexity and criticality of clinical trial documentation. Our team offers a full suite of Strategic Advisory Services that include business roadmap development, organizational change management, training design and development, and ongoing application support services.
These services transform clinical trial documentation processes and ensure sustainable processes.
Contact us today to learn more about our experiences helping sponsors, CROs and site teams implement collaborative site documentation operating models.
