Representative Projects: Clinical and Clinical/Regulatory Operations

Client

Accomplishments

Client Benefits

Global supplier of goods and services to the pharmaceutical industry

Developed the Clinical Investigator Brochure and IND Clinical Plan for a new product 

Designed, placed, and managed three Phase I trials--two in the UK, one in the US

Rapid confirmation of the clinical safety of a new drug delivery technology 

Definitive safety and pharmacokinetic data to support all planned patient trials

Development-stage biopharmaceutical company 

Developed the critical-path efficacy protocol; authored a crucial supporting overview document for FDA consideration 

Led the process of CRO selection and management

Timely protocol implementation, greatly increasing the chances of obtaining definitive efficacy data to meet a crucial financing deadline

”Virtual” biotechnology development company 

Created the Clinical Development Plan, Clinical InvestigatorBrochure, and Phase I protocol for a unique anti-infective biologic agent 

Oversaw site selection and conduct of Phase I trial

Solid conceptual and clinical foundation for a first-in-man study to address regulatory concerns, and to position this product for an innovative efficacy program