Full Service

Study Definition module

The Study Definition module is a web browser application which allows setup of studies according to study specifications including the forms and questions requiring completion; drug resupply settings; number of (drug dispensing) visits; the notifications to be sent informing participants of study progress; set the access rights for users; create reports and manage the participation of sites in trials. ALEA supports two types of of forms. ALEA’s own standard forms are mainly used for randomisation and DSM trials. For the design of more complex Case Report Forms, Microsoft InfoPath forms templates can be uploaded.

Data Management module

The online Data Management module is a web browser application that supports online completion of eCRF for healthcare trials. It requires initial login with a username and password, and subsequently provides a navigation menu for all trials to which the account has been granted access and the selected investigators for which the account has been granted permissions to access eCRFs. This access may allow the user to complete all eCRF’s or may restrict the user access to viewing all or parts of the eCRF’s.

Flexible Insourcing

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Full service pilot studies

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.

Training and certification

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.

DSM algorithms implementations

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.

Custom system validation

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.

Subscription Service

Unlimited IRT study design access

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DTAP deployment environments

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Baseline office hours support

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