Webinar On Demand: 5 Steps to TMF Inspection ReadinessThe Five Steps to TMF “Inspection Readiness” explores the real meaning of being inspection-ready and demonstrates why that goal is impossible without a more modern plan. Janine Penman, a clinical operations...
Clinical Operations as a distinct corporate function and department has evolved into a standard corporate model at sponsor and CRO companies, with all the trappings: Titles (e.g. Director of ClinOps), standard roles, its own language, a bevy of software...
When the COVID-19 pandemic started, traditional monitoring and quality management of sites became not only expensive and time-consuming but also impossible. Although things have settled somewhat, we have not gone back to normal and we likely never will. However, the...
Remember when we talked about how to know if it's time to bring the TMF (trial master file) in-house? Sponsors often decide to manage the TMF. We thought we'd follow it up with a couple of examples of sponsors who have been there. These examples are from episode one...
With so many eTMF solutions available today, how do you know which one is right for you? Many of these solutions provide similar features and functionality but there are ten requirements of a modern eTMF solution that you need to look for. And we're providing them...
From our work with a number of sponsors, CROs, and site organizations, there are five key things you need to do at the site level to ensure success when transitioning to remote monitoring and Clinical Trial Management.
Webinar On Demand: A Site Assessment Tool for Remote MonitoringAgatha sponsored the Proactive GCP Compliance Conference. Many dropped by our virtual booth for a chat about ClinOps technology, including TMF, Remote Monitoring, Quality, and Regulatory compliance.This...
Webinar On Demand: 5 Tell Tale Signs You are Ready for an eTMFLearn the five indicators that clearly signal your organization is not only ready for an eTMF but needs an eTMF to continue to conduct studies effectively. You will hear how other companies have analyzed...
You're having trouble managing the trial master file for your clinical trial. But how do you know if you need an electronic master file (eTMF) solution to help? It may seem like a simple answer, and maybe it is - if you’re looking at the right things. Here are five...
There is a lot of discussion about taking ownership of the trial master file (TMF). We wanted to understand what was behind this thinking of sponsors bringing the TMF in-house, so we reached out to an industry maven, Janine Penman of JPScientific, to fill us in. Who...