The Document Management
Cloud Service for
Life-Sciences and Healthcare

Agatha Cloud Service?


Clinical ETMF

  • TMF Ref. Model out of the box (multilingual, one reference).
  • Centralized artifacts and metadata management.
  • Patent pending for structured content authoring and Artificial Intelligence.
  • What’s missing management.
  • Quality control.
  • Management of advanced workflows (FDA1572).
  • Dedicated workspace for each trial.
  • IP Green Light


  • DIA EDM out of the box (multilingual, one reference).
  • Online parallel review, annotations and approval.
  • Compliant PDF rendition.
  • Compliant eSignature.
  • Document group (virtual documents).
  • Document exchange with partners.
  • eCTD submission viewer including hyperlinks management.


  • Effective SOP view.
  • Periodic review / Change control management.
  • Management of SOP translations and forms.
  • Auditors view.
  • Employee acknowledgement record management.


Get in touch


GCP Compliance

Agatha is fully equipped with all the functions necessary to manage GCP documents.


Users receive training using video clips, and record it when they start using Agatha.

This reduces administrative burden on training management.

Business Oriented Support

Ever been exasperated by Support members who don't understand your question? Agatha's Support Team fully understand business operations in medical an pharmaceutical industries, and answers your questions clearly.

Regulatory Compliance

Leave the complicated matter of compliance to the experts at Agatha. We provide you with a validated system that is compliant with GxP regulations and FDA 21 CFR Part 11. You will be up and running in PROD in a few days.

Cloud Service

Reducing operational cost and burden by going Cloud is a given these days. Agatha offers a highly secure, highly reliant, high performance, compliant, highly value-added cloud service that is optimized for business operations in the life science industry.

Low Price

User-friendly systems that are full of useful features are useless, if they are expensive. Agatha team delivers high-quality, low-cost service, leveraging the cutting-edge technology, know-how and expertise.

About Agatha

Our mission is to contribute to the healthier lives of people all over the world by providing best-of-bread and cost effective quality and content management solutions to clinical research organizations, hospitals and pharmaceutical companies.

Originally targeting the Japanese market (where Agatha position itself as the #1 provider for Cloud solution for Lifesciences), Agatha is providing its solutions globally (in full compliance with global regulations such as the US FDA's 21 CFR Part 11).

Agatha’s management philosophy is to achieve outstanding Technology and Operational Excellence through teamwork. In addition, we employ and nurture human resources with limited opportunities for work such as women and metropolitan areas.

Want to experience a one in a life time experience, working in a fast growing company, on best of breed technologies, in an exciting international environment? Contact us!

Chiemi Kamakura


100% of our customers are successful with Agatha. References welcomed.

As a record manager, I am using Agatha on a daily basis to QC check the ETMF and to update the list of artifacts. I love the ease-of-use and responsiveness of Agatha. Also love how easy it is to manage the reference model consistently accross trials.

Regulatory Expert CRO

I am using Agatha to manage SOPs, work instructions and forms for my site. It is very easy to manage documents periodic review, and distribution of documents for acknowledgement. The auditor view is also very easy to use.

Production Site Quality Manager Mid-Size Pharmaceutical

Some of our clients...

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