E-Documentation Study

Problem

Document processes inconsistent from one clinical and business unit to another.

Solution

To bring uniformity to all clinical trials study files, A10 created and implemented a project plan, developed new processes, trains users, develop and write SOPs, archive files and upload to new Electronic Data Capture (EDC) tool. A10 managed the documentation transformation process. This required the auditing of over 20,000 inactive study files, uploading to new system and the meticulous review of current studies. Remediation of files was performed to correct deficiencies. New processes and SOP’s were developed and training commenced with end users. External audit of vendors were conducted to ensure compliance. Change management was instilled through the organization. Resources supplied: Project Manager, Project Coordinator, CRAs, Regulatory Affairs Specialists and Software Support Specialist.