To further demonstrate the benefits of a centralized data outsourcing model, CROS NT discusses a cost-benefit analysis of choosing one vendor for all clinical data services. The benefits of a centralized approach include standardized data formats, improved traceability, greater leverage of work from one study to the next and significant cost reduction.
The benefits of this alternative outsourcing strategy can be seen in early phase drug development. Presenting a complete data package with full data, programs and TFLs and reports can speed up the due diligence process.
What do Sponsors face when data is not centralized?
|Problems Sponsors Face When Data Is Not Centralized||Solution: Benefits of Centralized Data|
|Lack of traceability of information||Less risk|
|Difficult cross product analysis – unexplained conclusions when numerous companies handle data||All data in one place: greater efficiency, consistent communications and reporting using common assesssment methods|
|Slow resolution of regulatory queries||Improved response to regulatory obligations|
|Unfamiliar with Sponsor requirements||Increased Value of Intellectual Property|
|Dispersed clinical data across a program of studies||Reduced Costs|
Centralizing clinical data services – including biostatistics, data management and medical writing – saves time by creating a global library of databases, shorter learning curves between CRO and Sponsor and easy access to study metrics. Quality is greatly improved through standardization, familiarity with customer processes, formats and templates and communication.
|Setting up global libraries, programming macros, validation checks||Pay one time fee for a CRO to set up these services|
|Regulatory Submissions and Reporting||Standardization reduces time, improves quality|
|Licensing fees||Volume discounts for EDC licensing fees and centralized hosting|
|Training and HelpDesk||Training time reduced, HelpDesk costs minimized when all sites adopt the same ePRO/EDC technology|
|Resource Utilization||Hourly/Daily charges per resource, FTEs billed monthly at lower rates|
CROS NT can provide a centralized clinical data solution for biostatistics and programming, data management, medical writing and accompanying technologies. We offer value by maximizing the reuse from previous studies, standardizing data formats, providing a consistent team – all with the objective of enhancing quality and saving up to 40% on cost.