Clarity Science is a mid-market Contract Research Organization (CRO) and a leader in conducting rigorous, late-phase research across diverse therapeutic specialties. They are expanding by taking on more trials and adding more sites to their network—today they lead trials across 240 international sites with 150 principal investigators across fifteen areas of research.
The Clarity Challenge
During 2015, Clarity was managing trial documents via email, fax, shared drives, and Excel. During this period one study saw a 15% month-over-month increase in misplaced study documents, revealing that homebuilt systems were coming up short. Clarity added additional staff to mange the document collection and tracking tasks, but the team met diminishing returns— staff communication and organization began to bottleneck. The operations team continued to discover missing or misplaced documents at key checkpoints.
The eBinders Approach
In 2015 Clarity partnered with Florence to fix the factors responsible for misplaced documents. Florence took the following steps:
- Problem Identification: In the face of disparate document channels (fax, email, shared drives), the absence of a shared platform to house and track access for all parties was determined to be the key issue.
- Solution Development: The eBinder Suite was configured to unify these disparate document collection channels by automatically compiling regulatory and source documents from fax and email. Barcodes were employed to automatically file inbound documents. The tool as then configured to provide real-time reporting—letting project managers monitor site output and track compliance.
- Deployment: Training and SOP services were deployed to align the clinical operations team with the new 21 CFR Part 11 compliant electronic document management infrastructure. The new workflow was tested and deployed to 120 sites.
Clarity’s sites began using the eBinder Suite with barcode reader, fax, and email connectors in early 2016. Over the following 3 months, Clarity reported the volume of lost documents had declined by 75%. Following the three-month deployment, Clarity decided to integrate eBinders into its clinical trial management system in order to make it a permanent part of its operations suite.