Match and Master Data to Predict Successful Site Performance
Selecting the right investigators and sites to run your trial has a direct impact on enrolment, patient retention, data integrity, study timelines and cost.
Pharmaceutical companies and CROs have access to a variety of data sources containing information about investigators and sites, but these data are often spread across multiple internal and external systems, each with its own set of identifiers. The lack of a common identifier generates inefficiencies throughout the clinical trial process such as sub-optimal site selection, need for repeat collection of administrative data, and inability to track payments across studies for investigators and facilities. In addition, the lack of a single common identifier was a significant barrier to facilitating cross-company collaborations as there was no mechanism for data sharing across pharmaceutical company and CRO clinical trial management systems.
DrugDev’s Solution integrates all of your investigator and site information to deliver a single, unified source that can be leveraged in master data management as well as in support of study planning, site identification, and site qualification. To enable pharmaceutical companies and CROs to make more evidence-based planning and site selection decisions, the DrugDev Solution features an intuitive interface with robust search capabilities.
The DrugDev Golden Number – Transforming Clinical Trials
DrugDev has developed, and continues to refine, a universal identifier for persons and facilities called the DrugDev Golden Number to solve the issue of integration across data sources. Using a combination of automated algorithms and manual curation, the DrugDev matching process improves over time as the system learns more variations for a single person or facility.
Recognizing the power of the DrugDev Golden Number, collaborations such as the Investigator Databank and TransCelerate’s Shared Investigator Platform and Investigator Registry have partnered with DrugDev to support data sharing and mastering.
Although the DrugDev Golden Number began as a method for facilitating data sharing in collaborations, the utility of this unique identifier was quickly embraced within pharmaceutical companies and CROs to drive…
- Operational efficiencies – Make better decisions based on integration of all available site and study data, with more accurate contact information and auto-population of documents (e.g. surveys, CTAs)
- Data mastering efforts – Create a single source of the truth with de-duplicated and cleaner records, and CTMS/data integration in the case of M&A or legacy systems
- Collaboration – Enable data sharing between sponsors (e.g. TransCelerate, Investigator Databank), between sponsors and CROs (e.g. integration of site target and do not contact lists), and between industry and sites via profiles (e.g. researchers provide information once, for use by many)
- Integrated reporting – Track cross-vendor activity and metrics, generate a consolidated view of current and historical study activity with investigators and sites, and manage financial/aggregate spend data for investigators and sites (e.g. to comply with the Sunshine Act)
Return on Investment (ROI)
To help you evaluate the return on investment from using DrugDev’s Solution and Golden Number, a customizable ROI calculator model was created. Please contact us if you would like to create a custom analysis of ROI for your company.
To date, 4 value drivers have been assigned dollar savings by nearly all companies using the model:
- Reducing the number of non-performing sites
- Decreasing the number of rescue sites needed
- Decreasing IT time/costs for mastering
- Increasing investigator engagement (which in turn can decrease study timelines during start-up)
Acceptance of the DrugDev Golden Number as the Industry Standard
With pharmaceutical companies, CROs, collaborations, authentication providers, and third party data providers already using the DrugDev Golden Number, the industry is well on its way to realizing a single identifier for use in clinical research as well as in broader company data mastering and reporting activities. Looking towards the future, we believe that the Golden Number has utility to the FDA and other health authorities in offering a more comprehensive lens into the global investigator community, including enhancing the information available for monitoring study conduct, which in turn offers the ability to greatly improve patient safety.