If you’re a clinical trial sponsor or pharmaceutical company, you know the importance of an efficient, error-free eTMF process.
The problem is, an electronic trial master file necessarily begins with a massive amount of data and trial study documents, coming from multiple sources in a number of different formats, both electronic and on paper. How can you keep all that study documentation organized and compliant with regulations like ICH GCP and FDA 21 CFR Part 11? How do you dramatically reduce manual data entry and free up your knowledge workers to be exactly that – knowledgable?
We can help.
Pioneered by life sciences industry veterans and developed by BerkOne’s team of enterprise content management experts, the new eTMF DocCollect solution makes it easy for pharma companies to intake, verify and make audit-ready study documentation. Configurable to your exact needs and specifications, eTMF DocCollect streamlines the handoff between CROs, study sites and individual doctors and sponsors. They submit documentation via their existing workflows, and you use it according to yours. eTMF DocCollect sits in between, normalizing documentation and injecting it directly into Veeva Vault, MasterControl, SureClinical or your eTMF system of choice.
Why eTMF DocCollect?
BerkOne’s eTMF document intake solution allows you to efficiently and accurately intake study documents from any source, in any format. Paper documents are imaged on-site or in our state-of-the-art Pennsylvania imaging facility, and automatically readied for injection into your trial master file system. Our industry-leading virtual rescan (VRS) capabilities deliver consistently high-quality document images regardless of the condition of the original documents, and data can be automatically extracted using optical character recognition (OCR). Digital documents are standardized and grouped, giving structure to unstructured data. If necessary information is missing, the CRO or site can be notified automatically.
As a result, your knowledge workers spend less time organizing documents, checking for data completeness and keying information by hand. Instead, they’re free to prepare your FDA/EMA submission, with full confidence that study documentation is validated, compliant and audit-ready.
With eTMF DocCollect, you get:
- Consistently accurate, complete study documentation faster than ever before
- Full audit trails and accountability
- At-a-glance status updates and document locations
- Full integration with Veeva Vault and other leading eTMF systems
- BerkOne’s years of content management and life sciences experience
Are you ready to simplify the study documentation intake process? Fill out the form on this page to contact BerkOne and learn more about eTMF DocCollect, the next generation of clinical trial document collection solutions.