Executive Clinical Research Consultingis a clinical research strategy and clinical product development consulting firm with headquarter in Greater Boston Area and operational office located in Kansas City. We formulate and implement strategies to develop clinical research  plans and innovation, with a customer driven focus. We offer a broad array of services encompassing the entire spectrum of clinical research management that include:


I. Clinical Services:

1. Clinical Research Services

    • Design of clinical development programs including budget estimates,

    • Outsourcing strategies & qualification of providers, due diligence and supervision of  CROs during clinical trial conduct for all phases of the drug development process,

    • Design of clinical trials & observational studies, patient recruitment strategies for all phases of the drug development process,

    • Design, preparation,  and review of  clinical protocols for all development phases, specializing particularly in clinical pharmacology, pharmacokinetic, bioequivalence, special formulations, and unique patient population research,

    •  Clinical monitoring.

2. Special Clinical Services: Early Human Development Services

  • Sets up of Early Development Services (EDS) operation -  (Phase I - IIa),

  • Assistance  and advisement  on designs of Clinical Development Plans, clinical strategies, and operational documents with the overall goal of reducing time and improve quality of the process,

  • Supervision of clinical trials (domestic and international) and evaluation of the results.

3. Clinical Project Management

    • Management of Clinical Trials Design, Monitoring, Reporting,

    • Providing  experienced projects, and products management support for all phases of the drug development process,

    • Execution and monitoring of global clinical projects, leadership of  global teams in clinical development,

    • Management and development of Staff and Resources.

II. Clinical Operation Services

  • Clinical Research Strategic Planning and Gap Analysis,

  • Definition of  Clinical Research and Operations model that fits the best company structure, and culture,

  • Mentoring  Clinical Project Management team,

  • Support of domestic and international clinical research strategies and feasibilities,

  • Training and support of clinical research management groups on successful clinical strategy during domestic, and international research,

  • Advisement on merger and acquisition integration strategies for international CROs and biopharma Clinical Research Departments.

III. Medical and Scientific Services

  • Communication with high level of expertise with key opinion leaders (KOLs) in various treatment areas to obtain meaningful and in-depth surveys results for  Scientific Assessments, and Marketing Presentations,

  • Education and advisement on  "fast track" early drug development strategy, an alternative clinical development approach which reduced time of drug development (up to 6 months) and diminished costs by combining various clinical trials under the umbrella protocols design,

  • Management of strategic scientific and business alliances within the industry,

  • Assistance  in the International Clinical Development especially in the new and emerging markets,

  • Preparation of clinical reports.

  • Strategic consultancy support for the life science venture capital industry. We provide specialized technology and assets assessment based on our deep understanding of the life science financing market.

IV. Regulatory Services

  • Review and assistance in the preparation of IDB, IND, A-NDA, NDA, BLA,

  • Review and assistance in the preparation of all regulatory clinical documents necessary for the conduct of clinical trials,

  • Support in IND submissions and communication with FDA.