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Up Coming and On Demand Webinars & Conferences
Learn How to Manage the TMF with Agatha Clinical eTMF
June 1, 2022 1 pm ET
During the session, you will see Agatha’s eTMF application in use as we start a study, add documents and files and work through review and approval processes. And we will go further, showing you how Agatha’s applications can connect trial sites into the TMF process, enabling remote monitoring and simplifying the collection of TMF content.
Learn How to Manage SOPs with Agatha
June 16th, 2022 1 pm ET
Join us on June 16th at 1 pm ET where we will take you through the key requirements for an SOP application, including the ability to track employee training records. We’ll show you how you can manage your SOP documents with Agatha SOP and how can track employee SOP compliance and training activities.
You will learn how to:
- Create and document policies using your own set of templates.
- Manage and monitor processes for creation, review, and approval of SOPs.
- Trigger periodic reviews at pre-set intervals to ensure up-to-date training activities and comprehensive documentation.
- Track employee SOP compliance and training activities using documents, videos, and quizzes.
- Use controlled print for paper copies.
- Maintain a record of previous versions with full auditing.
Matching ClinOps Technologies to ClinOps Realities
(The ClinOps Technology Adoption Curve)
How CROs and Sponsors Improve TMF Management with a Shared eTMF
Join Agatha and DZS Clinical Services on February 17th, at 1 pm ET (10 am PT), when they will discuss how clinical trial sponsors and CROs can leverage a shared electronic TMF as a hub for collaboration and coordination of the TMF. Watch the replay.
The Trial Master File (TMF) is the repository for all essential documents supporting a clinical trial. But its role is going beyond a simple storage container for files, as CROs and Sponsors work together to manage not only the collection of TMF documents but also the review and inspection processes, both internally and externally.
During the webinar, Agatha’s Head of North American Operations, Ken Lownie, and Kari Brown, Director of Clinical Operations, DZS Clinical Services, will discuss:
- The role of the TMF and how it is evolving
- Why CROs and Sponsors need to work together to manage the TMF successfully
- How the right eTMF enforces process coordination and collaboration
- The key features of a modern eTMF application
- How to build a shared responsibility model for the TMF
5 Steps to TMF Inspection Readiness
The 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 consultant with JPScientific Inc., and Ken Lownie, Head of North American Operations for Agatha, will explore what it means to be inspection-ready and take you through what you need to do to ensure your TMF content and data is ready whenever the auditors come. Questions answered:
- What does the FDA requirement to be “Inspection Ready” mean?
- How does an eTMF solution ensure Inspection Readiness?
- What are the five key capabilities an eTMF must have to ensure Inspection readiness?
- What does it take to implement an eTMF application?
- How do you make the case for bringing in an eTMF application?
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.
- 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
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
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.
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.
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