Burt Consultancy, LLC. talburtmd.com, Clinical Research & Drug Development Consultation Services

Burt Consultancy LLC (talburtmd.com) is a clinical research and drug development consultation service. We provide expert consultation on: 1. Early-phase clinical development. Matching developmental scenarios with Exploratory IND (Phase-0, microdosing) and proof-of-concept (POC) clinical trials. Logistic planning, regulatory consultations, study design, interim assessment, and strategic interpretation of results. 2. Drug development. Strategic assessment of developmental priorities and contingency plans. Integration of ‘omics’ approaches and novel technologies with marketing and regulatory realities. Assembly of respective subject-matter experts. 3. Neuroscience therapeutics development. Design and conduct of drug and device trials across all phases of clinical development. Antidepressants, mood-stabilizers, antipsychotics, neurodegenerative agents, Transcranial Magnetic Stimulation (TMS) and Vagus Nerve Stimulation (VNS). 4. Clinical research administration. Integration of clinical research units within parent organization, national and international regulatory frameworks. Preparation of operational standards. Certification. Preparation for monitoring, inspection, and audit visits. 5. Global clinical research. Hardware and administrative infrastructure. Bridging regulatory and cultural divides. Assembly of customized teams of experts to match project requirements. Access to local clinical research, regulatory, and legal experts in Europe, Asia, North America and South America. 6. Clinical research education. Establishing clinical research education programs with skills assessment, training, and monitoring. Development of public awareness initiatives. Individual mentoring and program oversight.