Common Pitfalls When Submitting Clinical Trial Study Data

Good quality clinical trial study data that comes through the FDA could potentially avoid delay in data extraction, review and verification that will help drive your product to ...
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What to Consider Before Conducting a First In Man Trial

Conducting a First In Man (FIM) clinical trial with a novel drug product is a complicated process that requires an abundance of caution. Also known as Phase 0 trials, FIM ...
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Do You Need an IND for Clinical Trials?

Generally speaking, if the intent of a clinical trial is to determine the safety and efficacy of a new drug, or changes to an existing drug, then IND submission is required. ...
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A Simple Guide to Designing an Effective Dose Response Study

For safe and effective use of new drugs, clinicians need to determine the appropriate starting dose and the best way to adjust dosage to the needs of a particular patient.  But ...
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