The Optiform team had the pleasure of partnering with Zimmer Biomet. The world’s largest orthopedic device manufacturer. In addition to collect data from surgeons that use their devices, Zimmer also pairs with prestigious universities in conducting 50 to 75 active clinical studies each year. Work of this magnitude leads to an outpouring of data that can quickly become convoluted and interrupt the integrity of the study. Zimmer requested Optiform help them find a solution to process their 1000+ case report forms (CRFs).
Medical Devices - Clinical Studies
Data Capture, Content Management
The goal was to find a solution to the large volumes of paper involved in previous clinical studies. By eliminating paper, the direct outcome would replace scanned and faxed clinical outcome forms while minimizing data discrepancies via real-time validations, as well as integrate with their existing content management system. Due to the sheer number of data sources, Zimmer needed to allow clinical research staff to design their own forms, export data, images and audit trails. Furthermore, the process would need to meet 21 CFR Part 11 compliance regulations.
After a series of investigations into the needs of the client, the Optiform team was able to recommend and implement HP LiquidOffice. The solution took advantage of the extensive LiquidOffice API making forms accessible through the existing web portal. In addition, the solution allows forms to be filled out while offline and submitted once back online, then stored for later retrieval through their content management system using a custom connect agent.
The successful setup and testing of 20 eForms on private web portal took less than 3 months. The client was both stunned and thrilled with the results. Their audit system was now in one system instead of several and data became readily available in hours vs. the previous two-week wait. The number of in-house data entries was reduced by 60% for the first year, eliminating human error and decreasing data discrepancies by 60%. Zimmer’s investment in Optiform had lead to a first-year savings of approximately $560,000.
Optiform offers a broad spectrum of data processing solutions beneficial and able to be customized to fit any business need. From standard human resource departments to the information produced through clinical trials, Optiform has a long history of maximizing the efficiency of all its clients. Although the Optiform to sit and hear your needs, personalized support and recommendations pre and post project ensure your long term sanctification with your paper free results. Contact us today to set up a personalized, one-on-one consultation on software recommendations. Already a valued Optiform client? Our customer support is ready to help.