When a clinical trial is carried out, it generates a huge volume of data and documents. That information is critical to our understanding of what is on trial, for example a drug, and it is essential to enable the trial to be evaluated. Taken together, the information tells the story of the clinical trial.
This documentation is collated in what is called the Trial Master File (TMF). On paper, this file would be unmanageable for complex trials; luckily, the clinical research industry is increasingly digitized, so technology is on our side. Electronic Trial Master Files (eTMFs) are revolutionizing how clinical trial documentation is managed.
Now, with a new partnership between Siron Clinical and eTMF provider Montrium, Siron Clinical are pleased to offer their clients the most cutting-edge eTMF technology so they can benefit from even more efficient and effective trial processes.
eTMF partnership to manage clinical trial data and documentation
Imagine a trial that involves three groups of participants testing a drug or a placebo, and generates 5 million data points, which is not uncommon. In addition to the data itself, other information is required to tell the story of the trial, from its design and protocols to the certification of qualified staff working on it.
If the information associated with a clinical trial is stored and organized well, other organizations and researchers will be able to replicate the trial and evaluate the results properly. But it takes more than a spreadsheet and folders of documents.
As experts in project management, clinical monitoring, quality control and regulatory submissions, Siron Clinical are committed to ensuring success for their customers, and the right eTMF is a critical element of success.
“Montrium were the perfect choice of eTMF partner for us – they are at the forefront of providing electronic solutions to small and medium-sized companies. The benefit for Siron Clinical is that we can continue to improve and increase the effectiveness of our organization, allowing us to provide the right solutions to our customers.”Jan Balemans, CEO at Siron Clinical.
The importance of the eTMF
One of the most important roles of the eTMF is that it can demonstrate whether the trial was conducted according to regulatory standards, which is a requirement when it comes to treatment approval.
Every eTMF usually has two parts – one managed by the sponsor organization and one by the investigator – and these are kept separately for confidentiality. While there is no standardized structure for the documentation contained in the eTMF, more complex trials will usually be structured first globally, then by country and then at the site level.
Whatever structure is chosen, managing the information is challenging. For example, for security reasons and to ensure the ongoing trial is protected, some documentation might need to be removed or sealed at certain times.
Regulatory organizations like the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK have guidelines for the use of eTMFs, helping those who are running trials. There are many aspects to check for any given trial, and this itself can be an administrative burden.
A high-quality eTMF makes the management of the documentation and data around a clinical trial easier and more robust, ensuring it is in line with requirements and easily accessible for the right people at the right times. For Siron Clinical, Montrium’s electronic trial master file solution eTMF Connect is ideal, and the new partnership will ensure that clients’ trials are run according to regulation and in a way that minimizes administrative burden.
eTMF Connect: a solution for success
eTMF Connect was designed using the TMF Reference Model, which provides standardized taxonomy and metadata and uses standard nomenclature to outline a reference definition of the content of the eTMF. Managed by the ED drug Information Association (DIA) Document and Records Management Community, it provides a basis for eTMF solutions that meet industry requirements and are standardized.
According to Montrium, “eTMF Connect combines comprehensive clinical eTMF functionality, advanced collaboration features, and complete scalability to create a dynamic, intuitive and powerful eTMF solution that provides unparalleled customer benefits and value.”
“We’re excited about the opportunity to work with innovative companies such as Siron Clinical to modernize trial documentation and provide better services to their customers.”Oliver Pearce, Director of Commercialization for Montrium.