Flexible Study Build Model Meets Changing Business Needs

"We didn’t go shopping, we knew we wanted to use Medidata and it was a matter of working to find the right study build model to fit our business needs.”
Patrick Zbyszewski, Director of Clinical Data Management, Onconova Therapeutics

5

Fewer days spent entering data

2

Weeks to build your study

25%

Faster eCRF data entry

The Challenge

Onconova faced difficulty screening patients due to unpredictable eligibility criteria for the rare indication qualifications of their studies.  Their old process for patient screening involved manual efforts, communicating with clinical sites through emails and non-documented telephone conversations to determine if candidates were eligible. Given their enrollment challenges, Onconova could not afford to lose qualified patients due to manual process errors and lack of quality control.

In 2010, Onconova first started using electronic data capture (EDC) to be on the cutting edge of clinical technology. Soon after contracting with another vendor, they began conversations with Medidata to move forward on the Medidata Platform once their contracted studies were complete.

The Solution

Onconova initially selected Rave EDC and Rave Coder. Over time, Onconova added more solutions than anticipated, including Rave RTSM and Edge Targeted SDV, which restructured their targeted monitoring plan and leveraged the full suite of Medidata reporting tools.

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:

  1. Being able to outsource the database build
  2. Working with Medidata implementation services to build studies
  3. 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.