Clinical Trial File Access Management
Streamline documentation for eTMF and eISF
A cost-effective solution for NHS organisations to manage clinical trial documentation
As clinical trials grow increasingly complex and costly, every efficiency counts. Extra steps and inefficient processes can delay life-changing or life-saving interventions, and overlooked compliance requirements can jeopardise a study.
Hyland offers a solution to efficiently capture, manage, track and report on clinical trial documentation throughout its lifecycle. Developed with The Royal Marsden NHS Foundation Trust, this powerful solution is built upon best practices and compliance frameworks, and allows you to leverage the NHS existing investment in Hyland.
Features of clinical trial file access managementHyland offers support for eTMF and eISF, best practice workflows, easy adaptability to study types, audit trails and the e-signing capabilities you need to manage clinical trial files efficiently and maintain compliance.
Unlike many clinical trial management options, Hyland makes Electronic Trial Master File (eTMF) and Investigator Site File (eISF) formats available for use within each study — and no separate username and password process required for the eTMF/ISF system, further streamlining the process.
Supports eTMF and eISF
Pre-configured workflows based on best practices for research settings let you get up and running quickly without extensive configuration.
Best practice workflows
The ability to adapt DIA Reference Model to different study types avoids unneeded work by excluding non-applicable folders (for example, pharmacy folder for non-CTIMPs). User-specific personal folders ensure centralised storage of relevant certifications per study.
Adapt to different study types
Gain full clinical trial audit trails and streamline compliance monitoring with automated date and time stamping for all actions by all users.
Comprehensive audit trails
Generate and record training with e-signature logs as well as delegate study tasks at sponsor and site levels with e-signature logs. Meets MHRA and HRA e-signature process requirements.
Quality-checking signoff processes ensure accuracy of upload, correct filing of content and certified copies of scanned documents.
Expedite clinical trials, increase efficiency and decrease compliance risks with Hyland on a platform proven for the NHS.
Benefits of clinical trial file access management
Get started in as little as 30 minutes. An intuitive graphical interface gets you up and running quickly without extensive training.
Get started fast
Protect files by controlling access based on roles, teams, specific users and passwords and control access to individual folders. Grant temporary study access to auditors, monitors, and inspectors. Pre-defined, standardised roles help get you started.
Flexible, secure control
Quickly identify missing documents and signatures. Eliminate unnecessary work by flagging content that is unneeded for specific studies. Ensure centralised storage of study certifications.
NHS organisations can leverage their existing investment in the Hyland content services platform and gain a powerful, cost-effective solution that streamlines data access while protecting it. Clinical trials content and data is stored within your Hyland platform and managed by your enterprise, decreasing compliance risks.
Cost-efficiency, easier procurements
The Royal Marsden NHS Foundation Trust informed and guided the design with best practices to align with the World Health Organisation (WHO) Good Clinical Practice (GCP) principles outlined in the EMA Guideline on content, management and archiving of the clinical trial master file.
Built-in best practices
Any NHS organisation with even small amounts of research can use this. Where some pharma solutions would be cost-prohibitive, this is an affordable option.
Jane Lawrence, Director of Research Operations,
The Royal Marsden NHS Foundation Trust