US Clinical Trial Document Management (TMF & ISF) Services
Accelerate your clinical trial with smart TMF and ISF management.
Effective document management is essential for the success and compliance of your clinical trials.
Our comprehensive document management services for Trial Master Files (TMF) and Investigator Site Files (ISF) ensure your study documentation is accurate, complete, and compliant with regulatory requirements.
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Intelligent Trial Document SOlutions for the Digital Age
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Regulatory Compliance
Our document management services meet FDA, ICH-GCP, and other global regulatory standards, ensuring your trial documentation is always audit-ready.
Efficient organization
We provide systematic organization and management of all essential documents, reducing errors and ensuring quick retrieval.
Secure Storage
Our secure document storage solutions protect the confidentiality and integrity of your clinical trial data.
Expert SupporT
Our experienced team offers guidance and support throughout the document management process, from initial setup to ongoing maintenance and archiving.
Clincial Trial Services
Our Clinical Trial Document Management Services
Trial Master File (TMF) Management
TMF Setup and Maintenance:
Establish and maintain a complete TMF for your clinical trial, ensuring all required documents are included and organized.
Establish and maintain a complete TMF for your clinical trial, ensuring all required documents are included and organized.
Document Tracking and Version Control:
Implement robust tracking and version control systems to manage document updates and ensure the latest versions are always available.
Implement robust tracking and version control systems to manage document updates and ensure the latest versions are always available.
Quality Assurance Checks:
Conduct regular quality assurance checks to verify the accuracy and completeness of TMF documents.
Conduct regular quality assurance checks to verify the accuracy and completeness of TMF documents.
Investigator Site File (ISF) Management
ISF Setup and Maintenance:
Establish and maintain ISFs for all participating sites, ensuring all site-specific documents are included and up-to-date.
Establish and maintain ISFs for all participating sites, ensuring all site-specific documents are included and up-to-date.
Site Communication:
Facilitate effective communication with sites to ensure timely submission and updating of essential documents.
Facilitate effective communication with sites to ensure timely submission and updating of essential documents.
Audit Preparation:
Prepare ISFs for regulatory audits, ensuring all required documents are present and properly filed.
Prepare ISFs for regulatory audits, ensuring all required documents are present and properly filed.
Additional Document Management Services
eTMF Solutions:
Implement electronic TMF (eTMF) systems to streamline document management processes and enhance accessibility.
Implement electronic TMF (eTMF) systems to streamline document management processes and enhance accessibility.
Document Archiving:
Provide secure long-term archiving solutions for clinical trial documents, ensuring compliance with regulatory retention requirements.
Provide secure long-term archiving solutions for clinical trial documents, ensuring compliance with regulatory retention requirements.
Training and Support:
Offer training programs for site staff and trial teams on best practices for document management and regulatory compliance.
Offer training programs for site staff and trial teams on best practices for document management and regulatory compliance.
Empower your clinical research with next-level document management.
Our experts are here to get your clinical trial to success.
Speak with a trial document expertFREQUENTLY ASKED QUESTIONS
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