Anticipating the requests of the guardians in post-MAA: our digital solutions for real-world studies.

Our experience in clinical trials and early access has allowed us to develop digital tools to anticipate the guardians' requests during real-world studies for the evaluation of drugs and medical devices (MD). In particular, in order to:

• structure real-world data in compliance with regulations

• verify effectiveness data

• understand and anticipate toxicities

• know the characteristics of the populations actually treated

• promote the proper use of the drug or MD

• master the organization of care related to the impact of the drug or MD

Our solutions bring significant added value to the guardians' requests by collecting real-world data to document the use of the drug and feed the evaluations requested by the HAS in the commercialization process. Safety through close patient monitoring and data comprehensiveness for the industry are the two major challenges that we ensure thanks to our expertise and territorial network.