Agatha
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.
In the landscape of clinical trial software, typical solutions often entail intricate installations, extensive user training, and substantial invoices.
However, in partnership with Agatha Inc., Arithmos presents a distinct approach.
Agatha solution is streamlined—no cumbersome installations, no intricate user training, and certainly no hefty invoices. Instead, we offer user-friendly, cost-conscious, and exceptionally effective applications.
Experience the simplicity and efficiency of our platform as we redefine your operational standards.
Through our partnership, Arithmos and Agatha are committed to enhancing the following processes:
- Clinical eTMF
- Remote monitoring
- Quality management
SOP - Regulatory management
We help you manage the entire process
In the landscape of clinical trial software, typical solutions often entail intricate installations, extensive user training, and substantial invoices.
However, in partnership with Agatha Inc., Arithmos presents a distinct approach.
Agatha solution is streamlined—no cumbersome installations, no intricate user training, and certainly no hefty invoices. Instead, we offer user-friendly, cost-conscious, and exceptionally effective applications.
Experience the simplicity and efficiency of our platform as we redefine your operational standards.
Through our partnership, Arithmos and Agatha are committed to enhancing the following processes:
- Clinical eTMF
- Remote monitoring
- Quality management
SOP - Regulatory management
Agatha Applications
Agatha Clinical
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.
Agatha Quality
A complete, closed-loop system for documenting Deviations, tracking Corrective and Preventive Actions (CAPAs), managing Audits and coordinating Change Control activities.
Agatha SOP
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.
Agatha Regulatory
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.
We provide comprehensive support throughout the implementation process of Agatha applications and during the entire system lifecycle, ensuring new technology is disruptive rather than destructive.
Our team of expert business analysts collaborate closely with you to tailor all Agatha applications, ensuring they seamlessly integrate into your company’s processes.
We optimise their operation and guide you through organisational changes necessary for effective electronic document management.
Through customised workshops led by our experienced business analysts, your teams gain hands-on experience with Agatha applications, empowering them to maximize their functionality.
Agatha: Our Business Analysts’ Support
We provide comprehensive support throughout the implementation process of Agatha applications and during the entire system lifecycle, ensuring new technology is disruptive rather than destructive.
Our team of expert business analysts collaborate closely with you to tailor all Agatha applications, ensuring they seamlessly integrate into your company’s processes.
We optimise their operation and guide you through organisational changes necessary for effective electronic document management.
Through customised workshops led by our experienced business analysts, your teams gain hands-on experience with Agatha applications, empowering them to maximize their functionality.
With us, system implementation transforms into a process review experience. We offer an optimised and straightforward approach to manage your R&D processes, supported by advanced technology.
Agatha: Benefits
Enhanced Cost-effectiveness
Agatha applications are ready to use, pre-validated and available in the cloud, cutting costs and speeding up deployment.
Plus, our validation package ensures a swift setup with minimal disruption.
Comprehensive Compliance
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.
Seamless
Integration
Our team of Business Analysts tailors the Agatha applications to ensure the perfect fit seamlessly into your processes, optimizing operations and providing reliable support through any changes. Transition smoothly and boost efficiency with Agatha.
FAQ’S
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.
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.
