Choosing an appropriate outsourcing method for clinical trials also means choosing the right technology solutions to enhance operational efficiency and reduce costs. An alternative outsourcing method which is gaining popularity is to centralize clinical trial data with one specialized vendor for all studies related to a single product or compound. Benefits include standardized data formats, improved traceability, greater leverage of work, and most importantly, a significant reduction in costs.
If one study team is assigned to trial design, data management, data analysis and medical communications from the start, common data standards can be applied. However, Sponsors should also analyze technology capabilities before committing to a centralized approach as the right technology, secure data storage and accessible reports are key to success.
The following is a cost benefit analysis for technology solutions in a centralized biometrics scenario:
Centralized Hosting: Applying a centralized biometrics strategy also centralizes data storage using a single database for all clinical data. This means there is only one database to maintain and one repository to back up. Security procedures can easily be put into place and data confidentiality is ensured, and data is easily transferable to the Sponsor via web portal containing metrics and reports.
EDC Solutions: Sponsors can also save on EDC licensing fees and database set up when centralizing storage. Arithmos can offer a variety of EDC solutions from low-cost, web-based solutions to more sophisticated and intuitive systems depending on study budget and Sponsor expectations.
Pharmacovigilance Applications: Likewise with PhV applications, Arithmos provides licensing and setup support. We have an Oracle AERS solution for product safety monitoring and compliance to help manage adverse events and reduce risk. Through an Oracle Business Process Outsourcing (BPO) agreement, CROS NT can optimize safety reporting and data visualization through direct access to safety databases or Oracle Business Intelligence.