eTMF Expert Services

Expert support to help manage your eTMF

Our Expert Services Team members are contracted, operational experts deployed as needed to assist in managing your eTMF. We help ensure inspection-ready compliance across all your studies.

We are here to help

We can lighten your load by providing outsourced TMF services, so you can focus on what you do best – drug development. We can help with scanning, document upload, QC, TMF management, inspection preparation, and much more.

Reduce your operational burden

Utilize our team of eTMF professionals to extend your bandwidth - for a specific project or on an ongoing basis

Drive efficiency through outsourcing

Eliminate the burden of recruiting, training, and onboarding new resources to operate your eTMF.

Keep systems up to date

Gain complete insight into your eTMF document management processes while promoting best practices.

Promote eTMF health

Measure the percentage of expected documents received and finalized in a study at pre-established milestones.

Ensure inspection readiness

Capitalize on our in-depth knowledge and experience to help ensure inspection-ready compliance across all your studies.

Expect more from your TMF Management

TMF Management and Oversight
Document Scanning
Document Placeholder Creation and Maintenance
Electronic eTMF Document Upload and Filing
eTMF Document Quality Control
Study Lock and/or Archive Readiness
eTMF Configuration Optimization

Expert service that soars above and beyond

We’re there throughout the life of the study to ensure the health of your TMF. Leverage our extensive system knowledge to promote continuous process improvement.

Utilize Our Expertise

Our experienced eTMF specialists promote best practices and provide support to make sure your eTMF is always complete, consistent, and compliant.

Improve Inspection Outcomes

We provide resources to help with continuous eTMF business process improvement to ensure that your systems are always inspection-ready.

Gain Total Insight

Get complete insight into your eTMF document management processes. Our service provides detailed metrics and reports on your documents, offering instant insight into the health of your studies.

Pay For Only What You Need

Modify scope of work as your business needs change and utilize our services only as needed. Whether you want to fully outsource management of your eTMF or just bring in additional resources for more support, we can help deliver results.