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Up Coming and On Demand Webinars & Conferences

5 Tell Tale Sign You are Ready for an eTMF

Learn 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 their needs and decided in favor of – or against – an eTMF.

Agatha joined up with CenterWatch for the following webinar which you can now watch on-demand

Every life sciences organization managing a clinical study needs to manage the Trial Master File. But there are lots of ways to collect and track TMF content, from paper to shared drives to complete software systems purpose-built – known as an eTMF system. The question is, how do you know that your organization is ready for an eTMF?

In this webinar, you will learn: 

  • The five signs that clearly signal your organization is ready to move to an eTMF
  • The most important features and functions of an eTMF application
  • The best predictors of success with a new eTMF
  • How an eTMF can save time and money, and how you can calculate those savings * How to build support internally for an eTMF initiative


      A Site Assessment Tool for Remote Monitoring

      Agatha 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.

      Agatha’s Head of Operations-Americas, Ken Lownie, held a session Monday, Dec 14th, 3:15-3:45:  A Site Assessment Tool for Remote Monitoring.

      This session introduces a toolset for measuring the fit and readiness of a study site, which can be incorporated into the overall plan for transitioning to a remote monitoring model. Here is what the session covers:
      • The Six Dimensions of evaluation for a site’s readiness for moving to remote monitoring
      • A “Heat Map” model to focus attention on the most critical areas to address before moving to remote monitoring
      • A Site Scorecard that provides a simple way to evaluate each site
      • A template for a Remote Monitoring Transition Plan that provides a phased project model


          Clinical Quality Oversight Forum

          Session: October 21st at 2pm: The Path to Successful Remote Monitoring

          Watch it on-demand (registration to the conference is required)

          Common Barriers to Successful Adoption of Remote Monitoring and Proactive Strategies to Overcome Them 

            • Understand the burden on sites when transitioning formerly onsite tasks to virtual
            • Discuss technology options and challenges
            • Identify organizational barriers and tactics to overcome them
            • Evaluate potential studies and sites for initial projects and identify success factors

          Clinical Quality Oversight Forum

          Join us at the virtual forum:

          Varying Stakeholders Weigh-In on The Good, Bad and Ugly Experiences of Remote Technology Adoption   

            • Examine the motivations and challenges of remote monitoring from the site, CRO and trial sponsor perspectives
            • Identify the profiles of successful remote monitoring initiatives
            • Review the technology selected and used in successful projects
            • Discuss direct experiences of remote technology achievements and nightmares
            • Leave with takeaways to overcome technology and behavior implementation obstacles


            Bringing ClinOps Technology to the Clinical Site: Stories from the Frontlines


            • Ken Lownie, Head of North American Operations
            • Jill Heinz, Director of Research, Family Care Research/Injury Care Research

            ClinOps software and systems that address source file management, SOP documentation, and trial management have been adopted across sponsors and CROs, but less so at clinical sites. This reflects a justified hesitation to put an additional burden on clinical sites, who are typically short of the staff and budget needed to support new technology.

            But some sites HAVE adopted these kinds of systems and are enjoying the benefits of automation in terms of efficiency and compliance. In this session, we will explore the challenges that face sites and a set of strategies to overcome them. We will attack the topic from two sides, first through the lens of the site and second through the eyes of a software vendor.

            Join us for this session and leave with:

            • An understanding of how ClinOps software fits into the world of the clinical site
            • An example of how one clinical site manager brought in a full range of software solutions successfully
            • A list of the challenges she faced and the strategies she used to overcome them
            • A perspective on the state of the software systems and solutions available today

            Implementing Remote Monitoring: Navigating Technical & Organizational Obstacles

            The 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 come with the COVID-19 crisis. In Agatha’s State of Remote Monitoring survey, 42% of the respondents indicate that a lack of an easy-to-use technical solution is the biggest obstacle to implementing remote monitoring. It’s clear that there is a lot of confusion about the technology alternatives.

            Ken Lownie, Head of Operations, Americas for Agatha, a provider of clinical and quality applications for life sciences, shares key insights from Agatha’s State of Remote Monitoring survey and provides a roadmap to guide your transition to remote monitoring practices and processes.

            You will learn:

            • The imperatives driving remote monitoring as a practice
            • Assessing the readiness of Sites and Monitors
            • Understand the technology alternatives
            • A standard set of application requirements for your selection process
            • Proven practices from those who have made the transition
            • Calculating the costs and savings of remote monitoring

            How to Fast Track Remote Monitoring

            Presented 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 remote monitoring solution and share what we’ve learned from early adopters.

            You’ll leave fully up-to-date on remote monitoring theory and practices, and with a “Quick Start” plan for implementing remote site monitoring for your clinical trials.

            Key things we will cover:

            • The current state of remote monitoring in practice
            • The critical capabilities of any remote monitoring solution
            • The other part of the equation: Remote Quality Management
            • A “Practical Guide for Implementing Remote Monitoring” in your organization

            Agatha is happy to join our partner Arithmos for a webinar that looks at the need for specialized solutions for managing quality documents and clinical trial information. We’ll demo the Agatha Application to show you how each application works together in a secure, compliant environment that you can get up and running quickly. 

            Agatha Applications for Quality Management & Clinical Trials

            You will learn:

            • How to use Agatha for the management of your company’s quality and clinical documentation and processes.
            • How to use a single tool to streamline the collaboration between QA, Regulatory, and Clinical departments.
            • The advantages of a cloud-based application that’s easy to use and fast to deploy.



            • Silva Gabanti, Managing Director, Arithmos
            • Guillaume Gerard, COO, Agatha

            About Arithmos:

            Arithmos, an ISO certified company, provides innovative IT solutions to clients in different business areas: Life Sciences, R&D and Professional Services. Our offer includes IT products, services, and consultancy.

            Past Webinars

            Webinar June 5

            Tri-I Biotech Clinical Information Network Summit

            Date: Friday June 5th, 2020 – 15.00 to 16.30 GMT+8 (Shanghai time)

            Join Agatha COO, Guillaume Gerard in this webinar with partner Tri-I Biotech to learn how to use information technology to improve the quality and efficiency of early clinical research.

            Gerard will join Grant Kuo, Vice President, Tri-I Biotech (Shanghai) Ltd.




            • Grant Kuo, VP, Tri-I Biotech (Shanghai) Ltd.
            • Guillaume Gerard, COO, Agatha

            About Tri-I Biotech:

            Tri-I Biotech is an information solutions provider to the Life Sciences industry and clinical trial institutions in China.

            The best way to know if an Agatha Application meets your needs is to try it out. And good news - we offer a free trial.

            Complete the form, select the application you would like to try and we'll reach out to get you set up as quickly as possible.

            Want a little more information on your trial process? Go here.


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