Pharmanet

Client:	A small biotechnology company conducting a 25-patient Phase I study of the pharmacokinetic interaction between its investigational drug and a chemotherapy agent. The investigational drug is to prevent chemotherapy-induced nausea and vomiting.

Challenge:	With a relatively small number of potential patients meeting protocol eligibility requirements, the study needs to complete enrollment on time and maintain patient compliance.

Solutions:	Assist sites in developing Study Process Plans that enable them to customize eligibility requirements and meet enrollment targets. Develop a notification tool for early identification of dose-limiting toxicities to ensure that they are not missed during enrollment of the first 6 subjects. Implement a timely, accurate randomization process for treatment-sequence assignment across international time zones. Maintain compliance with extensive PK draws and completion of the medication regimen while on study. Identify at least 2 back-up sites that could be brought on rapidly, if needed.

Outcome:	The study completed on time.