Resources for Clinical and Quality Professionals

Check out our resource hub packed with whitepapers and ebooks, datasheets, and much more.

Ebooks

Clinical Operations Software

Clinical Operations Software

Five Steps to Successful Implementation of Clinical Operations SoftwareWe wrote this ebook with Jill Heinz to help clinical site leaders plan the transformation of their business using clinical operations technology. Take a look at what’s inside the guide.Clinical...

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The Definitive Guide to Standard Operating Procedures (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...

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Indepth Guide to 4th Generation eTMFs

Indepth Guide to 4th Generation eTMFs

Managing the Trial Master FileA 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...

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Indepth Guide to Remote Monitoring

Indepth Guide to Remote Monitoring

Remote Monitoring & Quality ManagementA Technology GuideTABLE OF CONTENTS Remote Monitoring Basics What about Remote Quality Management? Remote Monitoring Technology Alternatives User Stories & Remote Monitoring Requirements Technical & System Requirements...

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The State of Remote Monitoring

The State of Remote Monitoring

In this report, we cover the results of our 2020 State of Remote Monitoring and Quality Processes survey and provide insights and guidance into the state of remote monitoring and quality management in clinical trials.Take a look at what’s inside the guide.Remote...

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Datasheets

Agatha Applications

Agatha Applications

Datasheet: Agatha Applications for Clinical & Quality ManagementA lot of time and effort goes into setting up and managing your clinical and quality processes. And a lot on the line if you don’t do it right. At Agatha, we won’t just give you applications to help...

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eTMF Datasheet

eTMF Datasheet

Datasheet: Agatha Clinical (eTMF)Agatha Clinical is an electronic master file (eTMF) application that connects all trial participants and processes in a single, cloud-based application. Leveraging the TMF Reference Model, Agatha Clinical includes standard templates to...

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SOP Datasheet

SOP Datasheet

Datasheet: Agatha SOPAgatha SOP is a cloud-based application that enables you to track employee SOP compliance and training activities. It comes with a standard set of templates and processes which you can configure to support your requirements. The SOP application...

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Remote ISF Datasheet

Remote ISF Datasheet

Datasheet: Agatha Remote ISFSponsors and CROs are required to conduct regular reviews of clinical sites to monitor the execution of a trial and the integrity of the trial data.  Agatha Remote ISF eliminates the need to conduct on-site monitoring visits. You can ensure...

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QMS datasheet

QMS datasheet

Datasheet: Agatha Quality (QMS)Managing the corrective and preventive action (CAPA) process is at the center of the continuous quality improvement process.   Agatha Quality provides you with a complete solution for capturing complaints and deviations, documenting...

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Regulatory Datasheet

Regulatory Datasheet

Datasheet: Agatha RegulatoryTracking and managing regulatory documents is challenging; managing it across offices and countries even more so. Duplicate content and a lack of visibility into regulatory activities increase your risk of non-compliance. Agatha Regulatory...

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