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Second Opinion on Phase III CTA 2017-03-14T13:21:53+00:00

Second Opinion on Phase III CTA

Background

The client had purchased an API development project at the stage when positive read-outs from phase II clinical studies existed. During the further development work aiming for phase III the client observed that the “purchased documentation” on the API solid state characterization work, e.g. the polymorph situation, was both complex and unclear.

Approach

Adroit Science went through around 20 scattered reports on solid state screening and characterization written by a series of different service providers related to the solid state characterization area.  We could confirm that the overall presented situation was very complex and involved many loose ends and unexplored question marks. By carefully scrutinizing the existing documentation we could separate out all the, to our opinion, “speculative conclusions” and extract a back-bone of valid knowledge.  We did also propose a detailed plan for how to present an honest and confident material for the phase III CTA at the same time as pin-pointing and working with the complementary studies needed to secure a safe and robust product rendering a successful market approval in the end.

Outcome

Our presentation of the solid state situation in the phase III CTA was approved without further questions from FDA rendering a very happy client.