Pharmaceutical. Biotech. Medical Device.

Software for Clinical Operations and Quality Management

Small and early-stage companies look to Agatha to manage their clinical, quality, and regulatory processes.

No complicated installations. No complex user training. No big invoice. Just easy to use, cost-effective, and highly efficient applications.

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A SharePoint or Dropbox folder is not enough to manage your clinical trial documentation.

But you also don’t want an expensive, difficult-to implement enterprise solution. 

With Agatha applications, you do more than manage documents, you manage the entire process for:

    • Trial Master File (TMF)
    • Standard Operating Procedures
    • Quality Management
    • Regulatory Management 

Applications for Clinical Operations and Quality Management

Agatha Clinical etmf

Agatha Clinical (eTMF)

Ensure every essential document is accounted for with a complete eTMF solution. You can be certain that the set of essential documents you need for every site and study is present and ready for inspection.

Agatha Remote ISF

Agatha Remote ISF Application 

Eliminate 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. 

“The decision to move to an electronic TMF and move its management in-house was the right decision for us. With Agatha’s help, we were able to configure an eTMF application that supports our needs today and can adapt with us as our processes evolve.” 
Archita Sharma

Clinical Research Associate, InCarda Therapeutics

Agatha Quality

Agatha SOP

Track every activity, collect every signature, and ensure every process is completed. You get a complete set of documents and records, ready for audit at any time.

Agatha Quality

Agatha Quality Management

You get 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 is documented, reviewed, and approved.



Agatha Regulatory

Agatha Regulatory

Track and manage regulatory documents across offices and countries. Eliminate duplicate content and improve your visibility into regulatory activities. Decrease your risk of non-compliance with a consolidated and authoritative source for regulatory submission content. 

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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