32% of FDA submissions have critical data conformance issues. Clearing up these issues delays market approval for vital drugs. We help you understand your studies holistically, ensuring that you’re inspection- and audit-ready.
We have partnered with Veeva Vault, the market’s leading eTMF software, and implement its capacities with our best-in-class processes, procedures and implementation experience. With Excelya’s industry-leading, dedicated eTMF team, you know that your studies are backed by the best.
To be submission-ready, your Trial Master File needs to be complete, consistent and accurate. We create a TMF plan, upload and review your documents to ensure that they are inspection ready, and then archive them using Veeva’s eTMF software to make sure your documents are readily available when you need them.
We can take care of every step of the process, or just one. Choose the offer that works best for you:
What is eTMF?
The acronym stands for ‘electronic trial master file‘. eTMF is a digital version of the the trial master file (TMF), where essential documents and data is collected and stored over the lifespan of a clinical trial – something which must be done for regulatory compliance reasons.
Historically a predominantly paper-based process, the digitization of the trial master file is infinitely beneficial to CROs, sponsors and regulatory boards alike.
Estimated to double in global popularity over the next three years, eTMF will become an integral part of the clinical trial process of tomorrow.
Instead of the vulnerable paper-based data collection methods of the past, efficient clinical trials of today embrace technology, using it to eliminate some of the challenges that old methods created. eTMF consists of using both software and hardware to facilitate the management of regulated clinical trial content.
There are two main benefits to managing your TMF electronically: efficiency and safety. By using a secure cloud-based platform, it will be easy for study team members to unify documents into one place. This makes it easier for sponsors to access study data at the click of a button, to avoid instances of human error, to make decisions quickly and to accelerate the trial process.
Having your trial data kept safe in a password-protected environment will ensure a higher level of patient safety. Excelya’s eTMF management goes hand in hand with scrutinous digital safety and protection. Data encryption diminishes many of the data safety vulnerabilities of the previous paper system, and eTMF system users can only gain access to data which is directly relevant to their work. Passwords to the eTMF are regularly changed and other safety precautions such as operational system checks can be implemented easily.
The auditing process is also much more efficient, with digital files being much easier for regulatory to access and assess. This reduces business risk dramatically.
Digital/cloud-based TMFs are also mostly free from the environmental risks and vulnerabilities that paper and physical documents are susceptible to, such as fire/elemental damage, theft and negligence.
FULL-TIME eTMF TEAM
Uniquely specialized team whose focus is solely on delivering eTMF projects
13 YEARS OF EXPERIENCE ON AVERAGE
A high level of task-related expertise, with up to 30 years of experience
EXCEPTIONALLY QUALIFIED TEAM MEMBERS
Our eTMF experts have a Master/PhD level education and receive regular training
HIGHLY KNOWLEDGEABLE STAFF
Experience in clinical studies across therapeutic areas and phases
Regardless of the service you choose, we ensure success by providing the following advantages:
The Excelya eTMF team are highly knowledgeable about data management and processing, with members with decades of experience in the CRO industry. They are passionate and enthusiastic about the innovations that eTMF will bring to clinical trials, and the knock on effect that it will have on patients’ lives.
Effective Statistics departments play a key role in successful clinical trials as they allow sponsors to confidently determine accurate and actionable conclusions from the data collected during the study. The core responsibility of the Statistics team is to support decision-makers with their determinations, by providing deliverables that are free of errors and biases. Their role spans across the trial design process, data monitoring, analyses, closing phase and reporting.