Clinical Trial Management Systems (CTMS) are crucial in managing clinical trials. They help to manage all the aspects of a clinical trial, such as scheduling visits, managing the trial budget, tracking study participants, and monitoring the trial’s progress. With each new release, CTMS providers strive to improve the functionality of their systems in order to better serve their customers.
In celebration of Trial Interactive’s remarkable 15-year anniversary, we are thrilled to announce our collaboration with LMK Clinical Research Consulting. Together, we will provide you with invaluable insights from seasoned industry experts designed to assist you in fostering a culture of inspection readiness and cultivating TMF Champions within your organization.
Last month, in the middle of the NCAA basketball tournament “March Madness,” TransPerfect’s Trial Interactive Life Sciences team attended the Fierce US TMF Summit, the first fully face-to-face US event since 2020. And, once again, I was able to catch up with Too Many Friends and colleagues.
An electronic Trial Master File (eTMF) audit trail is information that tracks the creation, modification, and/or deletion of data, including actions at a record or system level from an eTMF system.
Audit trails enable the reconstruction of the history of events occurring in an eTMF—essentially the “who did what, when, and why” within the system.
Why is it required?
It turns out that TMF not only stands for Trial Master File but also Too Much Fun and Too Many Friends! I was fortunate to attend the Fierce EU TMF Summit in person for the first time since 2019, and I was able to catch up with so many friends and industry colleagues.
Representatives from TransPerfect Life Sciences and LMK Clinical Research Consulting recently participated in the Fierce Trial Master File Summit from May 2 to May 4 in New Orleans, Louisiana. While in past conferences, the focus of discussion has been eTMF technology, this most recent conference marked an unexpected paradigm shift toward people- and process-related TMF solutions.
Successful trial master file (TMF) management requires constant and careful attention to each process, procedure, and guideline.
In October, we hosted the first-ever C3 Summit – a virtual event featuring a series of industry expert-led webinars focused on remote trial management and TMF insights. In this blog post, we share a recap of the session Looking Ahead to 2021 - Planning for Uncertainty.
This includes a discussion about what sponsors and CROs anticipate for clinical trials in 2021 after a paradigm shifting year for clinical research
The clinical trial regulatory inspection—among the most pivotal steps in reaching approval—is going through an evolution. Regulatory authorities across the globe are updating their requirements to keep up with new eClinical technology, the increasing complexities of clinical trials, and a new, unexpected variable: COVID-19.
