Clinical Trial File Access Management
This solution, developed with The Royal Marsden NHS Foundation Trust, helps organizations efficiently manage clinical trials.
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 jeopardize a study.
Hyland offers a solution to efficiently capture, manage, track and report on documentation throughout the life cycle of a clinical trial or study — with best practices and compliance frameworks built in. Developed with The Royal Marsden NHS Foundation Trust, the solution offers NHS organizations in the UK and Ireland a powerful, cost-effective way to manage clinical trial files and leverage their existing investment in Hyland.
Clinical Trial File Access Management features
Hyland’s solution offers support for electronic trial master file (eTMF) and electronic investigator site file (eISF) formats. You’ll also get best practice workflows, easy adaptability to study types, audit trails and the e-signing capabilities you need to efficiently manage clinical trial files and maintain compliance.
Supports eTMF and eISF
Unlike many clinical trial management options, Hyland makes eTMF and eISF formats available for use within each study. A separate username and password isn’t required for the eTMF/eISF system, further streamlining the process.
Best practice workflows
Preconfigured workflows based on best practices for research settings let you get up and running quickly without extensive configuration.
Adapt to different study types
- The ability to adapt the DIA Reference Model to different study types avoids unneeded work by excluding non-applicable folders (for example, a pharmacy folder for non-CTIMPs)
- User-specific personal folders ensure centralized storage of relevant certifications per study
Comprehensive audit trails
Gain full clinical trial audit trails and streamline compliance monitoring with automated date and time stamping for all actions — by all users.
E-signatures make things easier
- Generate and record training with e-signature logs and delegate study tasks at sponsor and site levels with e-signature logs
- Meets MHRA and HRA e-signature process requirements
Quality-check processes
Signoff processes ensure the accuracy of uploads, correct filing of content and certified copies of scanned documents.
Any NHS organization 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
Clinical Trial File Access Management benefits
Users can expedite clinical trials, increase efficiency and decrease compliance risks on an NHS-proven platform.
Get started fast
You can get up and running in as little as 30 minutes. An intuitive graphical interface can get you started without extensive training.
Flexible, secure control
- 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
- Predefined, standardized roles will help you get started
Efficient and thorough
- Quickly identify missing documents and signatures
- Eliminate unnecessary work by flagging content that is unneeded for specific studies
- Ensure centralized storage of study certifications
Cost-efficient and easy to access
NHS organizations can leverage their existing investment in Hyland intelligent content platforms and gain a powerful, cost-effective solution that streamlines and protects data access. Clinical trials content and data is stored within your Hyland platform and managed by your enterprise, decreasing compliance risks.
Built-in best practices
The Royal Marsden NHS Foundation Trust informed and guided the design with best practices that align with the World Health Organization’s Good Clinical Practice principles, as outlined in the EMA guideline on content, management and archiving of the clinical trial master file.
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