Omnica Biotech

CNS Pharmacology and Clinical Trials

about

Omnica Biotech

Omnica Biotech is a trusted partner in CNS research and development. Business, science and regulators pursue different goals and speak different languages. Many brilliant ideas get lost in translation. We know how to find common ground and focus on meaningful output driving idea to market approval.

We provide scientific advisory and R&D consulting in all stages of drug or medical product development – from lead selection to pre-clinical and clinical trials, from scientific due diligence to regulatory submissions.

Omnica also serves all shareholders in neuropsychiatric markets through engagement of thought leaders and development of educational materials. Scope of our educational services includes development of: CME-CPD-CEU modules for doctors and pharmacists, informational, educational materials for round tables course, materials for colleges, universities and other educational institutions  development of product-specific knowledge training programs, patient education materials, etc.

omnica

Expertise

Neuroscience/Pharmacology

Neuropsychiatric disorders

Translational research

Clinical trials

Psychedelic medicine

Mental health

Wellness and longevity

Precision medicine

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Services

Scientific advisory

  • Scientific due diligence
  • IP assessment and development pathway advisory
  • CNS pharmacology expert opinion
  • Connecting and liaising with opinion leaders, research centers, CROs

Translational Research and Drug Development services

  • Design, development and management of preclinical programs
  • Pre-IND and IND-enabling studies: identification, vetting and management of CROs
  • Pre-clinical data analysis and reports

Clinical trials: Project Management and Operations

  • Indication selection based on pre-clinical signal and market environment
  • Clinical trial protocol design and drafting
  • Investigator/CRO/site identification, vetting and relations
  • Regulatory submissions
  • Clinical project management
  • Clinical monitoring
  • Inspection preparation and readiness
  • Trial master file management

Medical Affairs, Education

  • Thought leaders engagement
  • Design and delivery of CME/CPD/CEU modules
  • Course development for educational programs
  • Medical science content development/review
  • Whitepapers and manuscript drafting

Highlights and Insights

Studies on cannabis use in pregnancy

Studies on cannabis use in pregnancy

Use of cannabis in pregnancy is a controversial issue. Find out more from this Forbes article by Sara Brittany Somerset with contributions from our...

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