eTMF Expert Services

Ensuring Ongoing Compliance and Inspection Readiness

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

eTMF Expert Services Help Support:

1. Document Placeholder Creation and Maintenance

2. Electronic eTMF Document Upload and Filing

3. eTMF Document Quality Control

4. Study Lock and/or Archive Readiness

5. eTMF Configuration Optimization

Utilize Our Expertise

 

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

 

Gain Total Insight

 

Get complete insight into your eTMF document management processes.  Our service provides detailed metrics and reports on your documents offering insight at all times.

 

Improve Inspection Outcomes

 

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

 

Pay Only For 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 a special progress such as an acquisition, we can help deliver results.

 

We train, manage and monitor TMF operational resources so you don’t have to, reducing your operational burden.

Total Transparency

 

We collaborate with you, serving as your subject matter experts.  We make sure you are constantly informed and aware, keeping you up to date by regularly providing comprehensive reports and delivering detailed metrics.

 

True Partnership

 

We’ve got your back throughout the life of the study to ensure the health of your TMF.  Our passion for adding value and continuous improvement translates to ongoing client success.

 

Request more information on how our eTMF Expert Services can help.

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