Overview
Clinical trials consulting addresses the regulatory, ethical, and scientific standards governing the design, conduct, and reporting of clinical research. MDT Expert Consulting provides access to clinical trial specialists, IRB experts, biostatisticians, and former FDA clinical review personnel who evaluate whether trials were conducted in accordance with Good Clinical Practice guidelines, informed consent requirements, and applicable regulatory standards in disputes involving research misconduct, protocol deviations, and data integrity.
Pre-Litigation Support
Before litigation, clinical trials experts help counsel assess whether the research conduct at issue deviated from applicable standards in ways that give rise to legal liability. They review protocols, informed consent documents, case report forms, and regulatory submissions to evaluate the integrity of the trial and the adequacy of protections afforded to research participants.
Litigation Support
In litigation, clinical trials experts assist in evaluating the statistical validity of trial results, identifying protocol deviations that may have affected outcome data, and assessing whether adverse events were properly reported and characterized. They help counsel frame discovery around trial master files, sponsor correspondence, and IRB records.
Arbitration Support
Clinical trials experts in arbitration address disputes involving research agreements, data licensing arrangements, and regulatory compliance obligations between sponsors, CROs, and research institutions.