Careful planning is the key
The current trend is towards web-based data capture solutions. Many of these are expensive and inflexible. We have our own in-house solution which is cost-effective and readily adaptable whilst retaining requirements for FDA CFR part 11 compliance. We can provide instant access to a suite of reports, or build something specific for your needs and the ability to conduct ‘monitoring from your desk’ to optimize the use of your precious clinical resources.
What happens if you want a combination of an eCRF and a “paper-based” Not a problem! We will work with you to develop the data capture process. Once the data fields are defined, it doesn’t matter if the process will be paper based, web-based or a combination of both. We will work with you to develop a CRF; this tool could be used for paper based data collection (and consequently becomes a key tool in the specification of the data entry screens) or for electronic data collection via the web. The same well-constructed, well laid out and well-conceived CRF can be a pivotal document for either system, and therefore can be used in both systems and allows maximum flexibility! In our experience, this is a service lacking in some of the “top-end” eCRF solutions, but we can readily encompass a hybrid solution in a cost effective manner; because we think clinically and practically, like you do, but we also bring a wealth of experience in data management.