Medidata TSDV

Video transcript: One hundred percent source data verification is not sustainable and it's not being recommended by our regulatory agencies. It is widely known that site monitoring costs make up a significant percentage of the clinical trial budget, of which more than half is spent on source data verification. Site monitors typically spend one day per month visiting every site in a study and nearly half of their time on-site doing SDV. EDC systems remain the primary source of the data to be reviewed, but research is also suggesting that while conducting one hundred percent SDV of this data, less than three percent of all case report form data is changed due to post data capture monitoring and dating cleaning. Imagine if instead of spending half of an on-site visit doing SDV, the CRA was able to shift their focus to higher value activities that ensure patient safety, improve data quality, and add to the success of your trial. ReefTSDV allows you to align your SDV efforts to your critical data and endpoints. You can configure your tier preferences at the visit, form, and even field level data giving you complete control. Monitors are often faced with working in solutions that require them to figure out what patients forms and fields to STV, often via a spreadsheet and some algorithm outside of the EDC. RAVE TSDV is fully unified with RAVE EDC, so through the use of dynamic task lists, monitors can quickly focus on the patients, visits, and forms they're interested in. RAVE TSDV is easy to use, set up, and modify as study data starts coming in from the sites. No matter what level of source data verification your study requires, our solution allows for flexible designs to support your needs. Users also have instant access to change the review plan as the study evolves, ensuring you're focusing your efforts on the highest impact areas. Using a combination of out of the box and custom tiers, you can design the review plan that best meets your study needs. While the solution will automatically assign patients based on triggers you define, you can automate reassignment of patients based on custom rules, but also allowing you full manual override. Brave TSDV makes your team more efficient. It improves the safety of your patient. It focuses efforts in the right areas to ensure you have success with your clinical trial efforts.