Services

Clinical Development:

• Development of Target Product Profile (collaboration with commercial team)

• Clinical-regulatory strategy for Development Programs; collaboration with other functional leads (statistics, clinical operations, regulatory, commercial, clinical pharmacology, pre-clinical toxicology, medical writing)

• Phases I, II, III, IIIb, and IV studies:

  • Study Planning and Design, including extensive literature review

  • Synopsis/protocol development & design, with options and analysis of options;

    • Analysis of primary and key secondary endpoints (for inclusion in package label), study entry criteria,

  • Study execution: primary medical safety monitor, data monitoring, expedited reporting of SAEs (in collaboration with regulatory and drug safety)

• Preparation of Regulatory Documents (clinical sections): IND applications, Study Protocols, Investigator Brochures (IBs), Clinical Study Reports (CSRs), FDA/EMA meeting briefing packages, New Drug Application (NDAs/MAAs) preparation and response to clinical questions; Risk Evaluation Mitigation Strategies (REMS) preparation, Statistical Analysis Plans (SAPs) (editor only),

• Clinical lead in face to face meetings with regulators

• Study start-up activities: CRO selection, site selection, CRO and site training, investigator meetings (clinical lead & protocol training)

• Analysis of study clinical data for purposes of next steps clinical-regulatory strategy

• Publication planning and development

• Clinical data presentations at scientific meetings

• Medical Affairs:

  • Medical review and adjudication of promotional materials

  • Publications planning, writing, and editing (abstracts, posters, oral presentations, manuscripts)

  • Medical Information: development and editing of standard response letters (SRLs) in collaboration with MI department

  • Clinical data live presentations at scientific meetings (abstract publications), advisory boards, managed care providers/payers

  • Sales force training modules development

  • Sales force training

  • Development of managed markets dossier

  • Selection and approval of Investigator Initiated Trials (IITs)

  • Oversee, train, and manage activities of Medical Science Liaisons (MSLs)
    

• Business Development:

  • Clinical review and evaluation of potential in-licensing opportunities

  • Due diligence visits to potential in-licensing companies

  • Clinical data summary reports and presentations to senior management

  • Out-licensing presentations to prospective interested customers