Registrat-MAPI

New legislation in the US, Europe and other countries has made demonstration of drug safety a key priority for drug approval and continued marketing. To thrive in this new era, the pharmaceutical industry needs to incorporate new strategies and tactics.

Pharmaceutical companies will need to change their drug development efforts to plan for higher thresholds of approval related to the relative benefits and risks of pharmaceuticals. This involves the development of a more comprehensive process of assessing potential risks in relation to likely benefits, alternative therapies and the disease being treated to drive the development of the product profile.

This process also makes it easier to anticipate and develop post-marketing surveillance and risk minimisation activities that may be needed in the post-marketing period. Both of these activities are increasingly required by regulatory authorities throughout the world to ensure that the benefit to risk profile remains positive for patients using the medication.

These changes to both the drug development and commercialization approach will help companies to improve management of product risks and ensure commercial success.

The Importance of Direct Patient Management Programs

Direct patient management programs reduce patient attrition rates and are vital to the success of a long-term Late Phase research study.

The requirements for late phase evaluation of product are becoming more and more evident with the launch of new innovative drugs. The pharmaceutical industry is organizing internal teams devoted to this evolving research and science by gathering all the expertise needed, including Medical Affairs, Epidemiology, Pharmacovigilance, Marketing, etc...

As a unique global Late Phase CRO, REGISTRAT-MAPI is specifically qualified to collaborate with these teams, globally and locally, with a worldwide presence. This science is becoming incredibly sophisticated and requires specific expertise. This is exactly what we have successfully achieved within REGISTRAT MAPI, with now more than 20 years of experience in both Europe and US. We are pleased to participate with our clients and partners to successfully navigate Late Phase evaluation.