eTMF Management Solutions

TriMForge®: eTMF Full-Suite Support

An holistic approach to takle your eTMF management pain points and ensure regulation compliance for your clinical studies.


eTMF: A Key Driver for Modernised and Optimised Clinical Trials

eTMF plays a crucial role in modernising and optimising clinical trial operations, facilitating efficient document management, ensuring regulatory compliance, and ultimately contributing to the timely and successful execution of clinical trials.

Main Challenges and Pain Points TriMForge aims to tackle:

Vendor Selection and Management

Choosing the right eTMF solution is critical. Organizations need to evaluate vendors based on factors such as system functionality, scalability, regulatory compliance, support services, and cost. Additionally, ongoing vendor management is crucial to allow smooth implementation, validation and maintenance processes.

Integration with Existing Systems / Processes

The eTMF exists within an ecosystem of tools and processes that manage trial aspects that serve as the sources of data or documents required for the TMF.

An efficient and compliant eTMF must operate in harmony with a variety of systems/processes to contain the necessary information.

User Training and Adoption

Transitioning from paper-based TMF to an eTMF requires adequate training for users to become proficient with the new system. Resistance to change and unfamiliarity with the software can lead to slow adoption rates and errors in document management.


Data Quality and Consistency

Maintaining data quality and consistency within the eTMF is essential for regulatory compliance and the integrity of clinical trial data.

Challenges may arise in ensuring that documents are accurately classified, indexed, and version-controlled within the system.

Regulatory Compliance

Ensuring that the eTMF system complies with regulatory authorities’ regulations as well as international standards.

Study oversight facilitation to allow inspection readiness.



Security and Data Privacy

Protecting sensitive clinical trial data from unauthorized access, breaches, or cyber-attacks is paramount. Implementing robust security measures, such as encryption, access controls, and regular security audits, is essential to safeguarding the integrity and confidentiality of trial data stored in the eTMF.

From the ‘craftmanship’ of Arithmos’ Technology and R&D Life Science Experts, we’ve developed an innovative solution to support your management of TMF and eTMF activities: TriMForge®


At Arithmos, we are a Veeva Preferred Services Partner for the Development Cloud (Business Process/Strategy and Post Implementation Support). Our team of Veeva certified consultants supports Life Science companies on their R&D journey.

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