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:
An approach to risk prevention unifying “quality by design” and “risk adapted monitoring”
A clinical study information system built on, and driven by, critical to quality factors
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 support you in the operational, legal and technical management of your compliance with the regulations and laws applicable to personal data protection and health data.
We are committed to contributing to the maturation of the DPO’s job in healthcare and clinical research, as well as to the development of instruments facilitating the use of data while guaranteeing a high level of protection for participants in research projects.
Benefits:
Enable a responsible sharing of clinical study data as a support to open innovation projects
Facilitate the appropriation of their rights by patients, and consequently increase their confidence in the responsible use of their data by the sponsors of clinical research
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.