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In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinicaltrials is increasing. The company partners with small and large biopharma and medical device and diagnostic companies to optimize early clinical development through excellence in study design and execution.
Leaving Out Pertinent Chemistry, Manufacturing, and Controls (CMC) Details. Using nonclinical data or manufacturing information that doesn’t adequately support the clinical protocol hurts the IND application. Ensure your study has evidence to support the robustness of the assay used in evaluating the clinicaltrial.
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