A pilot study is a requisite initial step in exploring a novel intervention or an innovative application of an intervention. Pilot results can inform feasibility and identify modifications needed in the design of a larger, ensuing hypothesis testing study.

ALEA Clinical Services provides training’s and courses for several elements of ALEA. For example the course can be about study set up in the Study Definition, Infopath, creating a study data base, eCRF development, monitoring data management, drug supply management and predictive drugs supply management.

All these training’s are provided by developers of ALEA Clinical. By the end of a course, the participant receives a certificate.

The Drug Supply Management supports both simple and complex drug distribution schemes. It includes per site resupply trigger levels and sizes, per site initial shipment sizes, upload of concealment lists, generating concealment lists, predictive resupply through pDSM algorythms with deltaS deltaT site accrual prediction. The IVRS service supports over 15 languages allowing end users to dial into a voice response system to complete dialogs using the touchpad of a standard telephone. Any dialog completed is treated as a form similar to the web interface. As a result, data collected trough the IVRS system is directly fed into the core database.

ALEA Clinical has several processes which contains documented manuals how the validation of the study and software is set up. This validation of the system is to ensure accuracy. reliability and consistent intended performance. The process of documenting is also to meets a set of defined system requirements from the client.