Clinical Development

Clinical Development Plans/Strategy/Budget and timeline estimates

Preparation of clinical section of INDs

Protocol design and preparation - Phases 1, 2, 3, and 4

Governmental regulatory agency clinical/medical representation

Clinical Project Management

Clinical Operations - CRO identification (clinical drug supplies packaging and labeling, clinical trial execution,      medical writing, site auditing), Request for Proposal preparation, analysis and recommendation, contract   

     negotiations, CRO project management;

Clinical Trial Medical Monitoring

Clinical Study Analysis, Interpretation and summarization

NDA/CTD clinical sections preparation, editing

Response to post-NDA regulatory clinical questions/meetings

Assistance in building a competent clinical development department (organizational structure, number of people, type

     and level of people, interviewing and recommending hiring, etc.

Interim/contract head of clinical development/Chief Medical Officer