Protocol Review Process Redesign
Overview
A top Fortune 500 health care company was looking to improve its protocol review cycle process. The current process utilized a manual system involving 14 separate paper forms. Process statistics and reporting, where available, were handled manually via data collection in a spreadsheet. There were several duplication and transcription errors due to the highly manual and multi-form based process. Additionally, information was not easily retrievable as it was contained in many different locations on hard copy forms.
Target
Review the current protocol review process and provide for a more streamlined, compliant methodology as well as an improved reporting approach.
Solution Delivery
eta one solutions began this project by following its standard process improvement methodology. This methodology involves 5 phases: Formalize, Measure, Analyze, Optimize and Sustain. Through this methodology our client was able to visualize the current state of data flow, understand recommended process improvements and gain efficiencies through a future state goal. The project included the implementation of a configured, off-the-shelf workflow software which required formal Quality Assurance testing to validate functionality. This particular project required eta one resources to utilize the client’s new and evolving internal, stage-gate project delivery methodology (based upon Crystal methodology). Our team trained on this internal methodology and through the course of the project was able to work with the Project Management Office (PMO) to make recommendations (based upon our diverse and extensive project management background) to further improve their initiatives.
Results
eta one provided its client with a tested, novel process and solution that improved protocol cycle time by 35% and reduced data collection and reporting time by 99%. In addition, the new solution reduced resource needs by 33%. Further benefits included:
Data Transparency & Centralization
Instant On-Demand Reporting
Fully Searchable Database
Offline Review
Automated Reminders
Asynchronous, Parallel Review
Universal Accessibility through Online Access
Improvement of Data Accuracy & Submission Rework through:
Rules-based Workflows
Data Submission Rules
Required Fields
Automated Data Checks
Single Source Data Capture (Removal of all Duplicate Data Sources)
Improved Navigation and Customer Experience
Simplified Data Collection Forms
Linked Data Sources
Restricted Drop-down Lists
Additional Efforts: Systems Rollout & Training
In addition to the above process improvement and systems implementation effort, eta one partnered with this client’s Education Department for the system release and rollout. This included the creation of multiple, role-based training web demonstrations, approximately 20 instructor-led, face-to-face training sessions worldwide, and 10 videoconference-based trainings. Additionally several work instructions, job aids and procedural documents were created and provided throughout the project. Overall, approximately 2,500 employees were trained worldwide.
