Nuts and Bolts of Early Clinical Research
You’ve answered some basic science questions about a drug’s safety and are ready to move to the clinic… There is a lot to consider including study design, cost/incentives, speed, quality, the participant pool, communication/language, partners, your market, standard of medical care, data integrity and more!
To answer these questions, we’ve tapped into an expert in study designs, trial protocols, data analysis and reporting in early clinical research to help you prepare before you take the next steps.
Mike DiSpirito, MSc
Director, Clinical Pharmacology & Pharmacometrics, Celerion
Mike leads a team of 30 scientists developing study designs and trial protocols in early clinical research, creating statistical analysis plans, conducting pharmacokinetic and pharmacodynamic analyses, interpreting and discussing study results, and generating clinical study reports. He advises various biotech and pharmaceutical companies on a wide range of clinical pharmacology topics.
JLABS @ TMC
2450 Holcombe Blvd., Houston, TX 77021