Example 1
Evaluation of cardiovascular effects reported in pivotal toxicology studies.
Initial findings in the safety pharmacology studies suggested a CV effect, an independent review of the ECGs from the pivotal toxicology study provided additional reassurance to progress the candidate drug in clinical development
Example 2
Due diligence data review.
In preparation for out-licensing Pharm Tox Consulting were engaged to review the current data package and conduct a gap-analysis on the pharmacology data. Secondly, to prepare a non-clinical development strategy - detailing study outline costs and timelines.