Agatha Clinical, Remote Monitoring, SOP, Quality and Regulatory
A new generation of online apps for Life Sciences Businesses
Agatha Applications are…
Agatha applications are ready to use and pre-validated. We eliminate the lengthy and cumbersome on-boarding processes typical of other systems so you save time and reduce costs.
Agatha applications for life sciences are pre-configured, but easy to modify just by changing parameters. That means the system adapts to its users, not the other way around.
Agatha business apps deliver better value. They save time because they are faster to implement save money because they cost less. Better results at lower cost means great value.
An eTMF management app that ensures every essential document is accounted for.
The Trial Master File plays the central role in every clinical trial, documenting processes, and ensuring compliance with protocols. With multiple sites, often across many countries, tracing every item in the TMF is a challenge.
Agatha Clinical is a complete eTMF solution, ensuring that the set of essential documents for every site and study is present and ready for inspection.
Agatha Remote Monitoring
An application for remote monitoring and quality control of clinical trial sites
Sponsors 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. But travel to Sites is expensive, time-consuming, and sometimes impossible.
Agatha Remote Monitoring eliminates the need to conduct on-site monitoring visits. It ensures monitoring activities can continue even when travel is impossible, such as during the COVID-19 emergency, and can eliminate travel costs completely.
An application for managing Standard Operating Procedures (SOP) and related training documents.
Managing SOPs and Employee Records requires a robust system that controls the authoring process, manages versions, executes approval processes, and tracks related training documents.
Agatha SOP is a comprehensive system that tracks every activity, collects every signature, and ensures every process is completed. The result is a complete set of documents and records, ready for audit at any time.
A complete, closed-loop system for managing Corrective and Preventative Actions (CAPA), Audits, documenting Deviations, and coordinating Change Control activities.
Managing the corrective and preventive action process is at the center of the continuous quality improvement process.
Agatha Quality is a complete solution for capturing complaints and deviations, documenting corrective and preventive actions, and managing change control processes. Every action is connected, from the initial issue to the new process, and every step documented, reviewed, and approved.
A complete, centralized location for managing all regulatory documents and information.
Tracking and managing regulatory documents is challenging; managing it across offices and countries makes it even more difficult. Duplicate content and a lack of visibility into regulatory activities increase the risk of non-compliance.
Agatha Regulatory reduces the complexity involved in managing regulatory documents prior to submission, providing a consolidated and authoritative source for regulatory submission content. Agatha also provides a central location to track regulatory applications and health authority correspondence.
But not just any trial - an Agatha trial.
Agatha offers a fully supported free pilot where you can test our applications using your real information and processes.
Just fill in the form
and we’ll get right back to you to get you set up.
If you're not sure, you can learn more about our Pilot process here. If you’re not quite ready to sign up for the pilot, request a demo instead.