Executive strategy reports
Using electronic data capture to improve the outcome of clinical trials
By Colin Spink
Summary Executive overview Business benefits A strategic approach to EDC Conclusion
A strategic approach to EDC 1| 2 | 3 | 4
A Strategic Approach to EDC
Pharmaceutical companies must take a strategic approach to the deployment of EDC to achieve significant, long-term business advantage. This must embrace both a new culture and corporate processes so they can exploit EDC to attain commercial benefit.
A strategic implementation of EDC ensures that it is both implemented in tandem with other corporate objectives and that senior sponsors play a role in instigating the necessary process and organizational change. It also ensures that the EDC technology is integrated into the corporate IT infrastructure to enable rapid access to clinical trials information throughout the company, which drives new business processes. The strategy should also encompass not only today’s technology, but envision how future developments will potentially impact the clinical trial process. Considerations for the future include:
Managing by exception will enable CRAs or DMs to focus only on the areas flagged as problems by the software.
Direct data entry should remove reliance on paper-based records and eliminate the need for Source Data Verification (SDV). There are regulatory issues associated with direct data entry: source data must be kept and archived at site and it must be possible to differentiate the data that has been entered directly and that which has not. Some companies are encouraging direct entry of data — indeed, a recent survey undertaken by Silico Research on behalf of IBM and others revealed that 22 percent of participants were entering data directly into the EDC system.
Pharmaceutical companies must take a strategic approach to the deployment of EDC in order to achieve significant, long-term business advantage.
The use of wireless devices, by physicians or patients themselves, is becoming more prevalent and will have implications for usage patterns.
EDC software also needs to link into Customer Relationship Management (CRM) solutions to ensure the sales force knows when visiting doctors, whether they are participating in trials, so they can leverage the existing commercial relationship.
Implementing the strategy
Once a strategy has been agreed there are four key areas that need to be addressed to ensure a successful wide-scale EDC deployment: Technology, Logistics, Process Change and Organizational Change.
Key success factors include ensuring a high level sponsor and addressing each of these areas in unison, not sequentially. EDC pilots are useful in facilitating user acceptance and enabling processes to be trialled. Companies can choose a limited, low-key pilot study to minimize risk although high profile pilot studies will raise awareness of the technology and ultimately bring greater rewards. Additionally, it is important to collect metrics to demonstrate the benefits of EDC. Ideally these should be collected for both traditional paper-based processes and EDC implementations to measure improvements.
Regulatory compliance — such as Food & Drug Administration (FDA) compliance is essential and will influence each of the four key areas. Under the FDA compliance requirements, implementation of EDC has to meet 21CFR part 11. Both software and Information Technology (IT) infrastructure need to satisfy specific requirements of 21CFR part 11 and all processes should be documented to ensure they can be audited by the FDA.