Our value chain


Clinical studies are exposed to significant risks for the quality of their data as well as for their delays.

Our answer is:

A risk-based quality management methodology, applied throughout the data lifecycle.

  A clinical study information system centered on the needs of investigational sites.

Benefits of a Clinical Data Management based on a “Quality by Design” approach:

A decreased time to market authorisation.

A more robust compliance to Good Clinical Practice.

A decrease of costs.

An increased probability of success.

A facilitated access to, and rapid processing of, a variety of data is key to clinical and translational research.

Real world data.

 Data from clinical studies.

 Biomarker data.

An intelligent clinical data platform supporting these requirements to feed innovation is part of our vision.

Benefits:

Contribute to a better understanding of the disease process.

Contribute to advancing personalized medicine.

A potential decrease in the number of subjects required for studies.


The responsible sharing of data from clinical studies requires to properly establish the balance between the data utility and the protection of personal data, in accordance with the regulations in force.

We offer expert solutions in data and content management, incorporating, by design, the principles of personal data protection.

Benefits:

Enable meta-analyses for health professionals.

Enable a responsible sharing of clinical study data as a support to open innovation projects.

Quality By
Design

Alcoam has adopted a quality approach based on an agile and adaptive methodology, and integrating the principles of Quality by Design. We summarise our method as follows :

• The value added for the end user is at the heart of the design
• Each solution is developed iteratively, and includes a test phase by the end user at each iteration
• We assume that our customers need to constantly adapt to a changing environment, therefore we design each solution in a scalable manner.

We apply these principles to the development of our professional services offering, training courses as well as technological solutions.

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