When it comes to clinical data outsourcing, Sponsors rely on several factors to select and qualify vendors. The most prevelant outsourcing method remains the use of full service CROs, but there is a growing trend to outsource based on CRO specialization including biometrics services and technology offerings. The centralized clinical data approach keeps all clinical data with one specialized vendor for all studies related to a single product or compound. Using this strategy, companies can save up to 40% on biostatistics and data management costs for follow-on studies.
But, what about technology?
Cloud-Based eClinical Technology
Technology services, including EDC and ePRO solutions, pharmacovigilance applications, centralized storage and data visualization can become part of your outsourced bundled package. Using the same ePRO/EDC/IWRS reduces setup, training and HelpDesk costs and allows for easy data integration.
The drug and device development industry is already familiar with cloud computing technologies for clinical research. Studies have estimated that cloud computing solutions can lead to a 30% increase in speed to trial for clinical work. If the market continues to adopt ePRO/EDC technologies, paper studies and subject diaries could cease to exist in 10 years.
Computer systems can cost a company up to $2 million USD plus the additional costs of installation and maintenance. Cloud solutions eliminate the need for hardware and software installation and allows clinical applications to be accessed through a web browser with personal log-in information. With no IT infrastructure to install, Cloud users can usually pay by study, or sometimes even by functionality used. This can result in huge cost savings.
eClinical solutions make it easy to collect and transfer data into one database for quick and accurate analysis. In terms of data management, the study team can resolve identify and resolve discrepancies faster ensuring automated checks.
With cloud-based eClinical applications, key performance indicators and the creation of clear Service Level Agreements with CROs are more achievable:
- Sponsors can negotiate expectations for clinical data entry into the eClinical application
- Move away from time-based unit of measurements to activity-based measurements
- Standard & ad-hoc reporting
- Real-time study management and access to data from any device
eClinical Applications for Risk-Based Monitoring
Clinical Monitoring activity can be greatly assisted through “Centralized Statistical Monitoring” in which statisticians use an algorithm tool to define risk areas and relevant thresholds. Off-site monitoring can be supported by data from EDC systems, CTMS, IWRS, safety databases and other study documentation.
Cloud-based data visualization and business intelligence tools allow for data retrieval, report development from different data sources and report delivery. For example, with RBM, duplicate records can be identified and subjects can be matched by birthday and/or initials to see if they are enrolled in the study more than once. Business Intelligence tools can also pull data from the data warehouse to perform risk assessments.
CROS NT Data Visualization
CROS NT provides clinical data visualization and business intelligence solutions to help Sponsors make sense of their clinical data. We provide Sponsors with web portal access to their clinical data including tabular and graphical reports from a single database or across multiple databases.