Centralizing clinical data is an outsourcing model implemented by CROS NT for its potential to increase quality, while at the same time, reduce overall costs. The benefits include standardized data formats, improved traceability, greater leverage of work from one study to the next, and most importantly, a significant reduction in costs. Centralizing clinical data can take the form of fixed price contracts per study or hourly/daily charges per resource to allow the flexibility usually only possible with in-house employees.
There is an added value for biotech companies whose business model is to seek a pharma partner or sell the product license on completing proof of concept or Phase II – being able to present all the clinical data related to the product in one place, fully traceable and portable, makes the sale more attractive and speeds up the due diligence process.
Here are 5 reasons biotechs should consider this outsourcing method:
1. One relationship between Clinical Data team and Sponsor
If one study team is assigned to trial design, data management, data analysis and medical communications from the start, common data standards are applied throughout the drug development process and there is continuity among team members.
2. Better integration of studies across all phases with common assessment methods
If the same clinical data project manager, lead statistician and data manager are involved from Phase I, they are able to ensure that the study protocol and Statistical Analysis Plan and Clinical Study Report are all fully in line with the study objectives.
3. Uniform traceability of data
All data is stored in a central data warehouse and/or archive which avoids having to keep track of multiple repositories.
4. One set of Standard Operating Procedures (SOPs) for your clinical data
The CRO can also act as a Quality Control Center for incoming deliverables from high volume providers. This can also including fixing incoming datasets to produce CDISC compliant documentation.
5. Centralization of study metrics and study reports
A CRO with accompanying technology solutions will provide clinical data visualization solutions in order to make sense of clinical data and analyze reports in real-time. Real-time data results allow decision-makers to identify and fix underperforming sites and make crucial decisions on study progress.
CROS NT and Centralizing Clinical Data
CROS NT can provide a cost-effective and efficient centralized clinical data package by providing data management, statistical analysis and programming and medical writing services. CROS NT can create a global library of databases which allows the re-use of previous programming work where CRF pages are the same or similar. Volume discounts can be obtained through bundling. We also have the proper technology in place including secure data storage and accessible reports.