R&D Infrastructure

The client is an early stage startup, developing a solution for a unmet medical need;

• The initial gap analysis identified poor data management practices, that could impact a smooth transition to pre-development activities.
• A documentation infrastructure was set in place, following best practices for future QMS compliance.
• An agile documentation traceability was designed to prepare the project to navigate through the required development activities.
• Training of team members performed.

This client would have benefit tremendously from the OpenRegulatory tool, Formwork, but preferred other routes.