In clinical research, maintaining accurate, complete and accessible documentation is essential to ensuring precision, compliance and effective oversight throughout a study. As clinical trials continue to become more complex, the need for efficient document management systems has become even more important.
What is an eTMF?
The Trial Master File (TMF) is the collection of essential documents that allows the conduct of a clinical trial to be reconstructed and evaluated. Historically, these records were maintained in paper format. Today, many organisations use an electronic TMF, which provides a secure digital environment for managing study documentation throughout the trial lifecycle.
An eTMF supports the organisation, storage, review and tracking of trial documentation in a centralised system. It also helps ensure that records are maintained in line with applicable regulatory requirements, including ICH-GCP guidelines.
Why Pharmalys implemented an eTMF
For Pharmalys, the implementation of an electronic Trial Master File (eTMF) was a key step in improving the way clinical trial documentation is managed across projects and teams. The decision to implement an eTMF was driven by the need to strengthen document oversight, improve transparency and consistency across studies, and support more efficient collaboration between teams and external partners.
The implementation has provided several operational benefits, including:
- Improved compliance: Documents are maintained in a structured and consistent manner to support regulatory expectations and inspection readiness.
- Operational efficiency: Automated workflows and standardised processes help reduce administrative burden and improve day-to-day document management activities.
- Increased collaboration: Global teams and partners can access and contribute to documentation in real time, regardless of location.
- Improved oversight: Dashboards and reporting tools provide increased visibility of TMF completeness, quality and overall status.
- Audit readiness: Well organised documentation supports faster preparation for audits and regulatory inspections.
The implementation process
The implementation of the eTMF required close collaboration across departments, careful planning and the establishment of clear processes to support long term use of the system.
- Vendor selection
The process started with a detailed assessment of organisational and operational requirements, as well as applicable regulatory expectations. Several eTMF vendors presented demonstrations of their systems, allowing Pharmalys teams to evaluate functionalities such us: usability, scalability, compliance capabilities and vendor support.
Selecting the right technology partner was an important part of the process. The chosen solution needed to support current operational requirements while also providing flexibility for future growth and development.
2. Process design and standardisation
Alongside the system selection, Pharmalys conducted a review of existing SOPs and document management practices to identify areas requiring standardisation or process improvement.
Document filing structures, naming conventions and quality control processes were standardised to promote consistency across studies and teams. Additional procedures were implemented where required to support the new eTMF environment and ensure clear responsibilities across functions.
3. User acceptance testing
User Acceptance Testing (UAT) was a key phase of the implementation process and played an important role in confirming that the system met both business and regulatory requirements before go-live.
This phase involved strong collaboration between Clinical Operations, Quality Assurance, and IT teams at Pharmalys. Comprehensive test scripts were developed and executed to assess core functionalities, including document upload, indexing, workflow management, access controls, quality controls and reporting capabilities.
Real-life study scenarios were used to validate end-to-end processes and confirm that the system performed effectively in a practical operational setting.
Any issues identified during testing were carefully documented, investigated and resolved in collaboration with the vendor prior to deployment. This process helped ensure that the system aligned with operational needs and that users were adequately prepared for implementation.
4. Go-live
The go-live phase marked the transition from system preparation to full operational use. This stage was carefully planned to minimise disruption to ongoing activities and ensure a controlled implementation across teams.
Close coordination between Pharmalys teams and the vendor supported a smooth transition to the new system and allowed users to begin working within the eTMF environment with the appropriate support in place.
5. Change management and user adoption
Successful implementation of an eTMF depends not only on the system itself, but also on how effectively it is adopted by users across the organisation.
To support this transition, Pharmalys established a structured training programme to provide users with the knowledge and confidence required to work effectively within the system. This included practical training sessions, user guidance materials and ongoing support during the implementation period.
Clear communication and defined processes were also important in helping teams adapt to updated ways of working and ensuring consistent use of the eTMF across projects.
Team acknowledgement
Pharmalys would like to acknowledge the significant contribution of Aissatou, Clinical Trials Technologies Team Lead, and her team throughout the eTMF implementation process.
The commitment, coordination and continuous involvement of Aissatou and her team was instrumental in the successful delivery of the system across the organisation. From system evaluation and testing through to deployment and user support, the team played a central role in ensuring a smooth and effective implementation.
Pharmalys would also like to recognise the valuable collaboration and support provided by the Clinical Operations, Quality Assurance, IT and other cross-functional teams involved throughout the project. The successful implementation of the eTMF was the result of a collective effort across departments, with teams working closely together to support process alignment, system validation and operational readiness.
The successful adoption of the eTMF would not have been possible without the hard work, expertise and dedication of everyone involved.
You can learn more about our technology platforms at Pharmalys here
The next steps
The implementation of the eTMF has established a stronger foundation for document management and oversight within Pharmalys’ clinical trial operations.
As studies continue to evolve in complexity and scale, digital systems such as eTMF will remain important in supporting efficient collaboration, maintaining compliance and improving operational consistency across global projects.
Pharmalys will continue to assess opportunities to strengthen processes, improve system utilisation and support teams in maintaining high quality TMF management practices.
By establishing a more structured, consistent and efficient approach to TMF management, Pharmalys continues to strengthen the quality and integrity of its clinical research activities while supporting regulatory compliance and inspection readiness across studies.
To learn more about Pharmalys’ eTMF solutions, download the eTMF Solutions brochure
