A new generation of applications for clinical and quality professionals
Agatha Clinical, Remote ISF, SOP, Quality, and Regulatory
Committed to your success
A 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 manage your documents and processes, we’ll be right there alongside you as you work through what you need to do and how to configure the applications to support your processes.
Check out the applications you can use to manage your processes.
Agatha Clinical (eTMF)
Ensure 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 and regulations. 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 ISF Application
Remotely monitor and control the quality of your 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.
Agatha Remote ISF eliminates the need to conduct on-site monitoring visits. You can ensure monitoring activities continue when travel is impossible (like COVID-19) or you want to lower travel costs.
Manage 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. You get a complete set of documents and records, ready for audit at any time.
Agatha Quality Management
Manage CAPAs and Audits, document deviations, and coordinate change control activities.
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 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.
Centralize and manage all your regulatory documents and information.
Tracking 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 reduces the complexity involved in managing regulatory documents prior to submission, providing you with a consolidated and authoritative source for regulatory submission content.
Why choose an Agatha Application?
Maybe you’re wondering why you should use Agatha’s applications. It’s a great question and we want to give you some important reasons to consider us.
Save time and reduce costs
Eliminate the lengthy and cumbersome onboarding processes typical of other clinical and quality systems. Agatha is ready to use and pre-validated.
An App that Adapts to You
Agatha applications for life sciences are pre-configured but easy to modify just by changing parameters. We’ll even help you do it.
You don’t need to spend weeks or months getting set up. Agatha delivers value out of the gate and adapts as you work through your processes.
Configure, don't customize
Easily adjust Agatha applications to your specific requirements without re-validation using parameter configuration.
Our applications are designed around regulatory requirements. We know the regulations so you can ensure compliance.
Get the Application Edition That Works for You
Agatha applications come in three editions, each with additional functionality.
- Pre-validated functionality for core ClinOps processes
- Check-in, Check-out, and Version Control
- Electronic Signatures and Complete Audit Trails
- Flexible review and approval workflows
- Full compliance with 21 CFR Part 11 and related Regulations
- All Standard Features, Plus
- Advanced reporting with Metrics and Dashboards
- Live Co-annotation for simultaneous review of documents
- Custom forms capability
- Advanced, role-based access management
- Everything in Extended
- “In Application” Microsoft Word and Excel editing – No Word required
- Live collaborative authoring and editing
- Extended template sets for SOPs, Informed Consent, and more
- Integration toolkit with Rest API support
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.