PRO Claims

With the FDA draft PRO Guidance and EMEA reflection paper having outlined new standards for using PRO endpoints in clinical research, it is essential that any team has experience and regulatory insight to optimize clinical trial programs.  At Mapi Values, our outstanding Endpoint Review team boasts many years of experience and can make a tangible difference particularly in the early phases of a product life.
 
By planning a strong strategy starting with the end in mind, raising any issues and proposing solutions early in the process, we prepare and prompt our clients to have essential discussions with regulatory agencies that will increase the possibility of an ultimately successful PRO submission. 

In response to the first and most common FDA hurdle, “the concept is the claim”, Mapi Values has created a centre of excellence for qualitative research. Our objective is to undertake state-of-the-art qualitative research to substantiate the underlying concepts of labeling or advertising claims.  Our ability to put forward well-researched and documented PRO measures that satisfy the FDA’s requirements is without peer in the marketplace.  Our continuous involvement with the FDA has provided us with a unique understanding of the value of a well thought-out and targeted endpoint model followed by a detailed conceptual framework.

We also ensure the alignment of the concepts measured with the proposed label within the context of the trial population, design, analysis and interpretation of the results. Based on our experience with PRO submissions to the FDA, we have developed and currently use an internal list of quality checkpoints to guide early decisions and identify gaps before submissions.

Our experience of working with the FDA and EMEA is critical to the success of our offering. With a former FDA figurehead now working within our highly talented team, we know that the services we offer our clients, along with the ongoing training we provide to our PRO team, puts us in an enviable position of strength.