Insights and guidance around clinical research and quality management
Our goal is to provide you with the information you need to get the job done.
Learn How to Manage SOPs with Agatha
Webinar On Demand Learn How to Manage SOPs with AgathaJoin us as we take you through the key requirements for an SOP application, including the ability to track employee training records. We show you how you can manage your SOP documents with Agatha SOP and how can...
Webinar: Learn How to Manage the TMF with Agatha Clinical eTMF
Webinar On Demand: Learn How to Manage the TMF with Agatha Clinical eTMFJoin us for a deep-dive webinar on what makes for a modern, fourth-generation eTMF. We will walk through the essential capabilities you need to automate the collection, management, and tracking...
TMF Inspection Readiness – Is Your Company Ready? Webinar Summary
What does TMF inspection readiness mean? What is required to get inspection-ready? And what technology can help you be inspection ready at any time? These were the questions answered at our recent webinar with our partner Arithmos. So whether you’d like a refresh or...
Mablink Integrates Its ERP with Agatha
One of the things we like at Agatha is to see how our customers are using our applications in new and unique ways. Yes, we have applications specifically for SOP management, managing the trial master file, and remote monitoring, but some customers also take advantage...
Agatha CEO Talks About Japan’s SaaS Startup Success
Agatha’s CEO, Chiemi Kamakura, joined the Disrupting Japan podcast to talk about Japan’s SaaS startup industry, her company’s success, the role of female founders, and much more. Here’s what they talked about: The real reason Japanese hospitals can’t get away from...
The Transformative Impact of the Humble SOP
Whenever anyone starts a discussion of Standard Operating Procedures (SOPs), I immediately hear the “wah-wah” voice of a parent in a Charlie Brown cartoon. And like Charlie Brown and the gang, I immediately tune out and start thinking about my plans for the weekend....
ClinOps Software – Where Should You Invest Next?
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...
Matching ClinOps Technologies to ClinOps Realities
Webinar On Demand: Matching ClinOps Technologies to ClinOps RealitiesAs a ClinOps leader, you are awash with an alphabet soup of technologies to facilitate Clinical Trials, including eTMF, IDC, AI, eTMF, CTMS, and IVRS. But all technologies are not created equal....
A CTMS-Lite for Small to Mid-Sized ClinOps Teams
There is a clear pattern in every software category: the emergence of a standard set of capabilities that comprise the very definition of the category. For example, at one point (a long, long time ago now), we all came to understand exactly what a spreadsheet...
Improve CRO and Sponsor Collaboration with a Shared eTMF
Traditional thinking says that an electronic trial master file application (eTMF) is simply a repository for storing documents related to a clinical study. But today, that’s only partly correct. A modern eTMF application provides so much more to the clinical...
TMF Management: The Project Plan to Bring the TMF In-House
We’re continuing our discussion on how sponsors can successfully bring management of the trial master file (TMF) in-house. This discussion is part of a seven-part podcast series that Ken Lownie, Agatha’s head of North American Operations did with Janine Penman,...
How CROs and Sponsors Improve TMF Management with a Shared eTMF
Webinar On Demand: How CROs and Sponsors Improve TMF Management with a Shared eTMFJoin Agatha and DZS Clinical Services as they discuss how clinical trial sponsors and CROs can leverage a shared electronic TMF as a hub for collaboration and coordination of the TMF....
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...
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 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
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...
Gustave Roussy Selects Agatha eConsent to Manage the Remote Verification of Informed Consent of Targeted Studies
Boston, MA, USA; Lyon, France; Tokyo, Japan. Agatha Inc. announces that Gustave Roussy, the first oncology center in Europe, has selected Agatha to assist with the remote verification of patient Informed Consent. Pour lire ce communiqué de presse en français, veuillez...
5 Steps to TMF Inspection Readiness
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 Trial Performance Metrics: The Core KPIs
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...
The Future of Remote Monitoring of Clinical Trials
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...
Sponsor Managed TMF: Two Examples of Sponsors Who Brought the TMF In-House
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...
The eTMF Requirements You Need (Infographic)
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...
A Site Assessment Tool for Remote Monitoring
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...
5 Tell Tale Signs You Are Ready for an eTMF
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...
5 Signs You Need eTMF Software
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...
Bringing the TMF In-House A Guide for Sponsors
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...
Adopting Clinical Operations Software? Do These 4 Things
Adopting clinical operations software can be an enormous undertaking, and there are many aspects that a sponsor, CRO, or clinical site will want to address before taking this step. 1. Do Your Research Before Adopting Clinical Operations Software Start with defining...
Bringing ClinOps Technology to the Clinical Site
Webinar On Demand: Bringing ClinOps Technology to the Clinical Site: Stories from the FrontlinesWith: Ken Lownie, Head of North American Operations Jill Heinz, Director of Research, Family Care Research/Injury Care Research ClinOps software and systems that address...
Calculating eTMF Savings and Payback: An ROI Calculator
An Ode to the eTMF. Sonnet 43, Revisited. Oh, eTMF, how do you save me? Let me count the ways. When I extol the virtues of an eTMF application, I am sometimes asked to be more specific and more quantitative. When I say confidently that an electronic Trial...
Podcast Ep1-It Time To Bring Your TMF In-house?
Janine Penman joined us for a 7-episode podcast to discuss the process required for sponsors to bring the TMF in-house.
Bringing the TMF In-house: Episode 2
Janine and Ken discuss the things you need to put in place before you bring the trial master file in-house.
Bringing the TMF In House Episode 3
In episode 3 of our podcast, Ken and Janine discuss budget and staffing requirements.
Bringing the TMF In-house: Ep 4
Janine and Ken talk about the importance of ensuring the project is adopted and successful.
Bringing the TMF In-house: Ep 5
There’s always a technology element to any discussion about bringing management of the TMF in-house, and that’s what this episode is all about.
Bringing the TMF In-house: Ep 6
Ken and Janine talk about the need to integrate clinical sites in the TMF process to ensure a seamless transition of information between sites and sponsor.
Bringing the TMF In-house: Ep 7
In episode 7, Janine and Ken talk about TMF operations and inspection readiness. This is a must-not-miss episode.
Can I Please Have a QMS App for Managing Clinical Quality?
Learn the difference between clinical quality management and manufacturing quality management.
Agatha Announces New Capabilities and New Extended and Premium Editions of Its Suite of Clinical and Quality Applications
Boston, MA, USA; Lyon, France; Tokyo, Japan. June 10, 2021, Agatha Inc. announced new features and capabilities for its clinical, quality, and compliance applications for life sciences companies. A total of 11 new capabilities were announced, focused on...
Agatha Inc Announces New PRISM User Interface
New UI Delivers High Performance and Accelerates Adoption Tokyo, Japan; Lyon, France; Boston, MA, USA. February 25, 2021. Agatha Inc. announces the official release of its new PRISM User Interface for the Agatha Suite of Clinical Operations and Quality...
How to Fast Track Remote Monitoring
Webinar On Demand: How to Fast Track Remote MonitoringPresented by Ken Lownie at MAGI Cloud Conference. This session is a master class in Remote Monitoring and Quality Management and how to put it into production fast. We will cover the critical capabilities of a...