Resources for Clinical and Quality Professionals
Check out our resource hub packed with whitepapers and ebooks, datasheets, and much more.
Ebooks
SOP RFP Template
SOP RFP Template Your Guide to Creating an SOP Application Request for Proposals Storing SOPs in a file share or a Dropbox and managing how your employees view and are trained on them in a spreadsheet can be complex and hard to control. An application that helps you...
Beyond Storage: How CROs and Sponsors Work Together
Beyond Storage: How CROs and Sponsors Work Together to Manage eTMF OversightWe partnered with DZS Clinical Services to discuss how clinical trial sponsors and contract research organizations (CROs) can work together using an electronic TMF as a hub for collaboration...
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...
The Definitive Guide to Standard Operating Procedures (SOPs)
Download this guide to get an overview of standard operating procedures (SOPs), why they are essential, and how you can create and use them in your organization. We also provide a list of the key requirements for a solution to manage your SOPs.
The Essential Guide to 4th Generation eTMF
Download our guide to learn about the evolution of eTMF systems and how this new 4th generation eTMF provides a complete, easy-to-use, low-cost, application for managing your TMF.
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...
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...
5 Keys to Successful Remote Monitoring
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.
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...
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...
Datasheets
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...
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...
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...
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...
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...
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...