Agatha for Pharmaceutical Companies
Solving Challenges in the Pharmaceutical Industry
Streamlining Clinical Trial Document Management
Managing hundreds of essential and related documents in clinical trials can be overwhelming. Agatha offers a centralized cloud-based document management system, making it easy to create, store, and manage essential documents. With seamless review and approval workflows, Agatha enhances efficiency and ensures compliance with industry regulations.
Reduce the Burden of New Drug Approval
Agatha simplifies new drug approval by providing a pre-configured CTD (Common Technical Document) structure, covering M1 to M5 document lists and folder organization. All regulatory submission documents can be centrally managed within a secure cloud environment, reducing the complexity and workload associated with regulatory compliance and submission processes.
Streamlining Clinical Trial Progress Management
Managing clinical trial progress efficiently can be challenging. With Agatha’s system, users can create, review, and approve documents seamlessly, ensuring that all stakeholders have access to the latest version in real-time. Unlike traditional file servers, Agatha provides centralized progress tracking, making clinical trial management simpler and more efficient.
Optimize SOP Management
Users can easily register, edit, review, and approve SOPs, ensuring compliance with Part 11 and QMS standards. The system automates SOP expiration tracking and provides real-time visibility into training records, improving efficiency and regulatory compliance.
Reducing the Time and Cost Burden of Regulatory Compliance
Regulatory compliance is an unavoidable challenge in clinical trials and medical research. Agatha streamlines complex compliance processes, reducing the burden on system administrators and minimizing both time and costs.
Simplifying Global Clinical Trial Operations with Multilingual eTMF Support
Agatha provides a multilingual eTMF solution, enabling seamless collaboration with international companies in the US, Europe, and beyond. As eTMF adoption expands globally, Agatha ensures compliance and efficiency in multi-country clinical trial management, streamlining document handling and regulatory alignment.
Our Products for Pharmaceutical Companies
What Agatha Can Do
Centralized Document and Process Management
Agatha enables centralized management of Clinical Operations and Quality Management related documents, streamlining creation, sharing, review, approval, and storage.
Enhancing Security and Efficiency Through Paperless Solutions
Agatha enables organizations to transition to a fully digital and paperless system, reducing workload and costs while strengthening data security. Our cloud-based solution streamlines workflows and ensures compliance with regulatory standards.
A Cloud-Based Document Management System for Global Compliance
Designed for international and domestic operations, Agatha meets global regulatory requirements, including FDA CFR 21 Part 11, GDPR, and EU Annex 11. It provides a secure, efficient platform for managing documents and ensuring compliance.
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