Accelerate and Improve Clinical, Manufacturing and Business processes
Use Agatha Clinical, Remote Monitoring, SOP, Quality and Regulatory applications to save your time and deliver therapeutic solutions to patients in a smart and cost-efficient manner.
We help you manage the entire process
Traditional clinical trial software focuses on managing documents. Arithmos and its partner Agatha Inc. think bigger – we want to help you to manage the entire processes. With us, you can focus on improving lives. We will help you to manage clinical, quality, and regulatory processes and increase their efficiency.
Arithmos and Agatha help you to improve the following processes:
- Clinical eTMF
- Remote monitoring
- Quality management
- Regulatory management
A cloud-based eTMF management application enforces best practices, document all activities, connect all study participants and all documents are ready for inspection.
Agatha Remote Monitoring & Quality Control for Sites
A complete, ready-to-use, and pre-validated solution for clinical sites that enables remote monitoring and quality management.
A complete, closed-loop system for documenting Deviations, tracking Corrective and Preventive Actions (CAPAs), managing Audits and coordinating Change Control activities.
A cloud-based application for creating and managing standard operating procedures from the drafting to the approval and employee training documents to ensure accurate records and complete compliance.
A complete, centralised location for collecting, coordinating and managing all the information and documentation required for regulatory submissions, involving external partners (eg. CROs), integrable with eCTD submission software.
Business Analysts’ Support
We support you in the implementation process for Agatha applications and during the entire system lifecycle, making new technology disruptive and not destructive.
Our expert business analysts support your team in tailoring all Agatha applications in order to:
- Ensure the perfect fit in your company’s processes
- Optimise its operation
- Implement organisational changes around management of your electronic documents
During customised workshops your business teams guided by our experienced business analysts learn functionality of Agatha applications at first hand.
With us, system implementation becomes a process review experience. We offer you an optimised and easy way to manage your clinical trials with a support of an advanced technology.
Agatha applications are ready to use, pre-validated and available in the cloud. They cost less, are ready for production use in days, and easier to use and adapt to Business Processes.
We provide a validation package to speed-up your validation process.
All the applications are built for the Life Sciences Companies around the highest industry standards and in full compliance with GxP requirements, EU Regulations, and FDA 21 CFR Part 11.
Our team of Business Analysts tailors the Agatha applications to ensure the perfect fit in your company’s processes, optimise your operation and support you in organisational changes around them.
Do I have to install something into my infrastructure to be able to use Agatha?
You do not need to install anything – Agatha applications are provided as cloud-based SaaS.
Is Agatha validated?
Agatha apps are fully pre-validated, ready-to-use applications. According to Computer System Validation best practices, your validation process will be simplified and focused only on the configuration adjustments and on the verification of your process.
Is it possible to have an audit trail report on the activities performed on a document?
Yes, the system traces all changes that you and your team make to the documents. Every action is documented in a complete audit trail, so you are always inspection-ready.
Is it possible to have customised user profiles?
Agatha comes with a set of predefined user profiles. Additionally, you can add new user-profiles and customise them in order to fit your workflow and your needs.
Does Agatha manage electronic signatures compliant to CFR21 part 11?
Yes, Agatha manages electronic signatures in compliance with the FDA CFR21 part 11.
From our resources
Accelerate and improve your Clinical, Manufacturing and Business processes!
Just fill out the form and we will get in touch with you to schedule a live demo of Agatha app that fits your needs the best.