Designing Clinical Research

Project: Mock clinical trial protocol to compare the safety and efficacy of two chemotherapy drugs in reducing cardio-toxicity in Her2 positive breast cancer patients.

Management of Clinical Research:

Project 1: Mock proposal to launch industry sponsored Phase I clinical trial.

Project 2: Mock proposal to launch industry sponsored global Phase II/III clinical trials.

Project 3: Mock portfolio expansion proposal for an academic Cancer Center.

Regulatory and Compliance Issues:

Project 1: Mock IND for Zyprexa, an antipsychotic medicine marketed by Eli Lilly

Project 2: Mock IDE for Radiesse Injectable Implant, used for correction of lipoatrophy in people with HIV marketed by Merz North America.