eTMF MANAGEMENT

Removing your burden of Trial Master File (TMF) management

The processes around creating, gathering and managing the files and the thousands of documents related to a clinical trial can be one of the most challenging activities. These records often come from many different sources, making the compilation of the trial master file in a timely manner, a burden. This has motivated many pharma and medical devices companies to move towards electronic TMF (eTMF). It is key to ensure that the staff engaged in the creation and maintenance of the TMF/eTMF are both skilled and experienced, to ensure that your TMF is complete, accurate, and audit and inspection ready at all times.

Our highly skilled TMF experts have, over the years, gathered extensive knowledge of clinical trials documentation management and gained experience with many eTMF platforms. Working collaboratively with our clients’ eTMF we have helped in achieving TMF success.

Simplifying and streamlining the management of your TMF documents in our shared eTMF

The use of eTMF to drive the TMF health is expanding slowly within the pharma and medical devices industry. Yet, eTMF selection and implementation to ensure an orderly transition from paper, with a stable foundation of detailed processes, remains a challenging, lengthy and costly process.

How can we help you?

We can help you plan, collect, and maintain your TMF in our shared, cost effective, e-solution that meets all regulatory requirements for documents management and privacy (e.g. 21 CFR part 11).

We offer our clients the combination of technology, expertise, and ready for use processes.

We invite you to join, access and contribute to your clinical trial eTMF health, anytime, anywhere.

Plan

Collect

Maintain

Increasing your clinical trial content quality by taking an “a-la-carte menu” approach

Our experts will assess your study requirements and processes, and will create a plan customized to meet your specific needs.

TMF plan development

to document the processes and management strategy to ensure an inspection-ready TMF for your clinical trial.

TMF index

to develop a complete TMF “table of contents” within the TMF Reference Model framework, that will establish clear expectations across all stakeholders.

TMF filling/uploading

to handle each document from clinical trial start to end.

TMF QC process;

to ensure document QC in high standards for successful TMF management.

TMF oversight

to continuously monitor the completeness and quality of your TMF as a whole, ensuring continuous inspection readiness.

TMF gap analysis

to identify missing documents, suggest corrective measures with each relevant study team and to ensure filling/uploading of the missing document.

Training and Client’s engagement

for optimal functionality of the eTMF.

TMF remote access to audit and inspection

Given the current attention to the TMF, regulatory agencies can show up at any time to perform a TMF inspection. Our cloud-based, remote-ready technology is configured to allow direct access to auditors and inspectors following a minimal training.

Contact Us

From study start to end, our TMF professionals are driven to ensure that our clients are first-to-market thanks to an accurate, up to date and complete TMF.

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