Agatha Archives

10 Agatha eTMF Questions We’re Asked During a Demo/Trial

10 Agatha eTMF Questions We’re Asked During a Demo/Trial

We get the opportunity to show our applications to customers and prospects regularly. As a result, we’ve started to see some common eTMF questions that everyone asks. So we thought we’d pull the top ten together and share them with you. You get a glimpse into Agatha’s...

Gustave Roussy Customer Story

Gustave Roussy Customer Story

Gustave Roussy + AgathaHow Gustave Roussy Verifies Informed Consents Remotely with Agatha when including patients in a clinical study Gustave Roussy is a global expertise center fully focusing on the care of patients diagnosed with cancer. The institute treats all...

Indepth Guide to SOPs

Indepth Guide to SOPs

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...

Implementing Remote Monitoring

Implementing Remote Monitoring

Webinar On Demand: Implementing Remote Monitoring: Navigating Technical & Organizational ObstaclesThe topic of remote monitoring and virtual trials is not new. But there is a new urgency to putting theory into practice in the face of the travel restrictions that...

The Future of Clinical Trial Remote Monitoring

The Future of Clinical Trial Remote Monitoring

The Fall Magi Conference is over, but there are still plenty of things to learn from the event. To help with that, here is a summary of the session Ken Lownie, our Head of North American Operations, did with Dr. Penelope Manasco, CEO of MANA RBM, about the future of...

5 Steps to TMF Inspection Readiness

5 Steps to TMF Inspection Readiness

The days of scrambling to get ready for an audit are gone. The FDA requires every clinical trial sponsor to be inspection-ready at any time. There’s no longer an option to find missing items, remediate duplicates or correct errors - but how can you ensure your team is...

Indepth Guide to 4th Generation eTMFs

Indepth Guide to 4th Generation eTMFs

Managing the Trial Master FileAn eTMF Technology GuideTABLE OF CONTENTS Introduction Who Needs an eTMF, Anyway? The Regulatory Requirement for an eTMF The Critical Role of an eTMF Three Generations of eTMF Systems The Need for a New Generation of eTMF Ten Defining...

Enlivex Customer Story

Enlivex Customer Story

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...