Clinical Development

Advise on clinical development strategies, target populations, study designs, endpoints etc, to meet indication and regulatory objectives

 Advise/develop novel study design options, especially for early proof-of-concept

 

Construct clinical development strategies and detailed clinical development plans (eg, study populations, study designs and endpoints, number of studies) to achieve regulatory objectives

Critical review and content assistance in FDA/EMEA submission documents including integrated summaries, clinical overview, SPC/package insert, study reports, protocols, investigator’s brochures, etc

Advise on, review and prepare clinical briefing documents for FDA meetings

 

Regulatory Affairs

Develop regulatory objectives and strategies for initiating human research (INDs) and registering products (NDAs).  Identify and advise on strategies for addressing regulatory risks/issues

Prepare regulatory documents: eg, integrated dossier summaries, justifications for regulatory strategy, FDA meeting requests and background documents, orphan drug applications, requests for fast track status

Plan, compile, and submit original INDs, annual IND updates, and IND amendments

Plan, manage and facilitate meetings with FDA

Provide relevant information and guidance regarding precedents, requirements, activities, trends, and changes in the drug regulatory environment.

 

Due Diligence and In-Licensing Assessments

Assess early development opportunities

Perform clinical and regulatory due diligence of potential licensing opportunities

Compile clinical and regulatory due diligence reports

 

Scientific Writing

Common Core Technical Document clinical modules 2 and 5

Clinical Trial Study reports