The Medidata model was an attractive solution for Onconova because of the value they experienced through flexibility and control over the study build process. They were able to employ a variety of different models including:
- Being able to outsource the database build
- Working with Medidata implementation services to build studies
- Configuring their own enablement after becoming knowledge transferred enabled
Depending on available resources and costs associated with various activities, Onconova was able to adapt their study build for the best model to fit their business needs at that time. From the beginning, it was important for Onconova to have ownership of their URL, which enabled them the versatility to outsource data management to different CRO partners for day-to-day management while maintaining the ability to run reports and collect data in one place and in-house.
Another reason they chose Medidata was that of the experience and familiarity of sites who knew and loved Rave EDC. “A lot of sites were happy to hear we were going over to Medidata,” said Zbyszewski. Onconova faced difficulty finding highly qualified sites for these hard to enroll indications, yet standardizing on Rave improved site relationships and recruitment.
The Results: Fast & Flexible Designed Trials
Onconova improved their operational performance by leveraging custom functionality within Rave EDC. Their new process for screening patients created an electronic screening communication between sites and medical monitors around patient eligibility. The new tool includes email notifications and an audit trail of the entire eligibility discussion, which alleviates manual errors from the old process and instead focuses on patient recruitment and retention.
Adoption of Medidata has given Onconova control and flexibility to pair their study builds with resource availability. This model has reduced costs on contracting third-party builders when it made business sense to build in-house and vice versa. Having ownership over their URL enabled Onconova to leverage the Global Library of resources and forms from the previous study builds. Standardizing their study build operations in one central location has promoted reusability and consistency across internal and external teams, and has reduced redundancies and effort when starting new projects.
Onconova has also changed their approach to risk-based monitoring since adopting Medidata. As a result of Edge Targeted SDV, they are now able to make better decisions leveraging reporting tools, experiencing reduced costs in monitor travel and the number of monitoring visits. Most importantly, Onconova has seen the impact of increased data quality as a result of implementing an ongoing data review process. They now have an ongoing review of consolidated data in place, which has replaced a point-to-point review process of the past.