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eTMF

Unlocking the Power of Electronic Trial Master File (eTMF)

Efficient management and organization of clinical trial documentation are essential for compliance and the success of any study. Backed by 25 years of legacy as a trusted CRO, Lambda Therapeutic Research addresses this need with an advanced Electronic Trial Master File (eTMF) platform. 

Built on cutting-edge technology, our eTMF streamlines the collection, storage, and management of critical documents and data throughout your trial’s lifecycle. Supported by a skilled and experienced team, we ensure seamless operations and a clear overview of your study. 

Lambda’s robust eTMF solution accelerates dossier compilation by over 60%, meeting diverse global regulatory standards efficiently and effectively. Our eTMF platform aligns with the FDA’s Guidance for Industry: Computerized Systems Used in Clinical Trials, ensuring robust data integrity, security, and compliance throughout the trial lifecycle.

The Lambda eTMF Advantage

Where technology meets compliance, and efficiency drives success in clinical development.

Stay Compliant and Efficient

  • Maintains detailed audit trails for transparency.
  • Meets rigorous regulatory requirements, audits, and inspections
  • Provides centralized management of clinical trial documentation.
  • Facilitates seamless exchange of clinical trial materials among stakeholders.
  • Streamlines TMF document workflows, quality control checks, and finalizations.

Key Benefits:

  • Reduced regulatory risk.
  • Flexible rights management.
  • User-friendly web-based application.
  • Part 11 compliant (21 CFR Part 11 and Annex 11).
  • Cost savings from increased filing efficiency and reduced paper.

Expertise

With over two decades of clinical research experience, it is meticulously designed to address the specific needs of the pharmaceutical and biotech industries.

Scalability

Our adaptable system accommodates trials of all sizes, from early Phase I studies to expansive Phase IV trials, ensuring seamless document management throughout.

Support & Training

We offer extensive support and training to empower your team, ensuring they can fully utilize the capabilities of our system for maximum efficiency and compliance.

To learn more about our technology, digital tools, and platforms, please click here.

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Connect with our experts to leverage our proven track record of clinical research excellence.

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