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P1 Source Upload is a remote monitoring solution that allows for the upload of unredacted source documents into a HIPAA compliant, cloud-based environment. It is unique because “certified copies of source” are uploaded and tagged with a single mouse click. Other solutions require 7-10 individual data elements to be manually tagged to each uploaded document. This increases site burden and because that task isn't automated, the data will need to be reconciled or re-monitored later by a CRA. P1 Source Upload’s auto-tagging feature avoids this expensive extra step and avoids delaying DBL too.
It’s currently being used by 2 top 5 CROs, directly by multiple small-medium sized biotechs, and at over 1,000 global sites (across +20 countries).
11:30 AM (IST)
Dr. Hugh Levaux is Founder and CEO of Protocol First. The company creates innovative software solutions for clinical research, with a particular focus on complex study designs in data intensive clinical trials. For more information, visit www.protocolfirst.com
Dr. Levaux brings to Protocol First over 20 years of dedicated experience in clinical trial design and operations, as well as web-based technologies—notably, Senior Vice President at United BioSource Corporation (UBC), Vice President of Product Strategy at Medidata Solutions; CEO of Ninaza, a web-based EDC provider; and Senior Vice President at Quintiles Transnational. Dr. Levaux has developed and commercialized multiple eClinical technologies in EDC, IVR/RTSM, ePRO/eCOA and trial-related technologies.