CliniOps leaders: Here is the question I want to focus on today. What is the next most important clinops software application you need to incorporate into your business? It is an important question because the right investment might allow you to overcome a critical...
The Definitive Guide to Standard Operating Procedures (SOPs)A Technology GuideTABLE OF CONTENTS What is an SOP? SOP Benefits Elements of an SOP Document Guidelines for Well-Written SOPs Training Employees on SOPs Tech Requirements for SOP Software Compliance...
Enlivex Therapeutics Adopts Agatha to Manage eTMFEnlivex adopted Agatha Clinical (eTMF) to help improve the management of its trial master file. Enlivex is a clinical-stage company focused on specialized cell immunotherapy, we intend to develop and commercialize an...
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...
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...
Jill Heinz, Director of Clinical Research, shares her insights on clinical sites and the value of clinical operations technology.
I have had nine - count them nine - meetings with Clinical Operations leaders at small, early-stage biotechs in the last week. After hearing what life is like when trying to usher an organization's first pipeline products through the clinical trial process, a...