CHALLENGE
The ability to effectively plan, collect and maintain essential clinical trial documentation is challenging and at times, risky. Driven by skyrocketing clinical trial costs, most life sciences companies now rely on contract research organizations (CROs) for the majority of clinical trials. While outsourcing to CROs can reduce costs, these partnerships increase the complexity of trial document management. The additional coordination required to collect and maintain trial documents can expose both the sponsor and the CRO to compliance risk.
SOLUTION
OpenText Electronic Trial Master File (eTMF), part of the OpenText for Life Sciences solution suite, enables life sciences organizations to easily and effectively control and synchronize study artifacts, track progress in clinical trial documentation, and ensure fast, secure access to documentation both during and after the trial. The solution ensures reliable regulatory compliance by enabling compliance with Good Clinical Practices (GCP), 21 CFR Part 11 including electronic signatures capabilities and other compliance capabilities such as dynamic user access controls, print controls, and preconfigured, dynamic watermarking and overlays.
Efficiently and securely operate the extended enterprise across geographies and external organizations with workflows, security models and collaboration capabilities designed for enhanced productivity and the virtualization of the clinical trial process.
The foundation of the solution includes the Documentum® Enterprise Content Management platform, Documentum® D2 for configuration and intuitive user interfaces, implementation and migration services.
