Agatha for Contract Research Organizations

CROs play a critical role in supporting pharmaceutical, biotech, and medical device companies in conducting clinical trials efficiently and in compliance with regulatory requirements. Managing multiple studies, sponsors, and stakeholders while ensuring regulatory compliance can be complex. That’s why Agatha provides a robust suite of applications designed to streamline Clinical Operations and Quality Management, enabling CROs to optimize study execution, collaboration, and compliance.

Solving Challenges for CRO

Centralizing Management of Multi-Sponsor Clinical Trials

CROs manage multiple clinical trials for different sponsors, each with its own regulatory and documentation requirements. Agatha’s cloud-based platform centralizes all trial-related documents, ensuring efficient organization, seamless collaboration, and easy access for sponsors, sites, and regulatory authorities.

Ensuring Compliance Across Multiple Regulatory Environments

CROs operate in a global regulatory landscape where compliance with FDA, EMA, PMDA, and other authorities is essential. Agatha simplifies regulatory compliance by providing a pre-configured, audit-ready document structure that supports adherence to ICH-GCP, Part 11, and other global standards.

Enhancing Sponsor and Site Collaboration

Effective communication between CROs, sponsors, and trial sites is crucial for study success. Agatha facilitates seamless collaboration with secure, role-based access to study documents, real-time updates, and automated workflows, ensuring smooth document exchange and compliance tracking.

Optimizing eTMF and Site Document Management

Managing essential trial documentation across multiple sites can be challenging. Agatha’s eTMF (electronic Trial Master File) and Investigator Site File solutions standardize document workflows, providing real-time visibility into trial progress, reducing compliance risks, and ensuring inspection readiness at all times.

Automating SOP and Training Compliance

CROs must ensure that their teams comply with evolving SOPs and training requirements. Agatha streamlines SOP management by automating document updates, approvals, and training records, ensuring that all personnel remain compliant with regulatory and sponsor-specific requirements.

Supporting Global Clinical Operations with Multilingual Capabilities

CROs often manage trials across multiple regions and languages. Agatha’s multilingual eTMF solution supports international collaboration, ensuring smooth document management and regulatory compliance across different regulatory jurisdictions.

Our Products for CRO

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.

Learn more about Agatha

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