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.
Document Tracking and Version Control:
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.
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.
Site Communication:
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.
Additional Document Management Services
eTMF Solutions:
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.
Training and Support:
Offer training programs for site staff and trial teams on best practices for document management and regulatory compliance.
"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."
Position
First & Last Name
"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."
Position
First & Last Name
"The wonderful people at Proxima have been dogged champions for our success. Aside from being deeply experienced in our particular field and keenly knowledgeable on developing trends they take our success as personally as we do. That, as much as anything, has been the difference."
COO & Co-Founder
Geoffrey Lucks
Proxima was instrumental to our success in getting breakthrough device designation for our product! The team was very knowledgeable and responsive and set us up for success. They made the FDA process easy to go through and prepared us for future interactions with FDA.
Co-Founder
Jade Doucet-Martineau
Proxima has been an important piece of Memgen's regulatory and clinical achievements for multiple years now, playing a vital role in our IND approval, clinical launch, and trial management of our first-in-human study of our lead cancer immunotherapy biologic. Proxima and its growing team have continually shown their experience, broad skill sets, adaptability to our company's needs and objectives, and value in an industry with a myriad of CROs to choose from.
CSO
Mark Cantwell
“Proxima has been such a wonderful help every step of the way. Everyone is truly great to work with.”
Junior Project Engineer
Karen Wells
We joined forces with Proxima's Quality Consultants to ready ourselves for upcoming audits of both our QMS and our parent company's QMS. Their approachable, expert team delivered essential support and insightful guidance, never shying away from directing us confidently towards the right path. We are proud to share our spotless ISO 13485 recertification audit, a testament to Proxima's steadfast commitment and fearless leadership!
Regulatory & QA Manager
Michael Selva
“As a busy surgeon developing a Class III implantable device I needed help with regulatory strategy and execution. I wanted someone that was as passionate about the device as I was and that could hit the ground running. Because PROXIMA supports emerging companies through Med Tech Innovator they were a perfect fit. Isabella also helped us manage other vendor relationships and kept things moving forward. I been very happy working with PROXIMA”
Founder
Marc Bessler, M.D.
"Proxima has been attentive to a variety of our regulatory related needs. From coordinating studies with aggressive timelines to assisting with sales aid approvals, they have always delivered. As we launched our first in class/disease product, we needed a high touch clinical research and regulatory partner, and Proxima has provided that for us."
Founder & CEO
Robert Whitehead
Developing medical technology for children has unique challenges. The Southwest National Pediatric Device Innovation Consortium (SWPDC) is a consortium supported by an FDA grant to assist innovators with their pediatric device development as well as address their regulatory challenges. Proxima has been a strong partner for us in helping guide innovators quickly through their regulatory and clinical journey.
Physician
Chester J. Koh, MD
We have had the pleasure of working with the Proxima team for over a year on overall regulatory strategy and support for FDA interactions. The entire Proxima team are unbelievably knowledgeable in this space with excellent communication skills, highly strategic thinking, and amazing customer service. We at Prenosis highly recommend them as a one stop shop for anything regulatory or clinical trial related, all offered at a very attractive price point.
CEO and Co-Founder
Bobby Reddy Jr.
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 expert

FREQUENTLY ASKED QUESTIONS

What should be documented in the software requirements specification?
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Glossary

21 CFR 820
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