EXPERT MARKET GUIDANCE for RARE DISEASE

BBCR Assists Researchers in Finding Homes for Orphan Drugs or Treatments for Rare Diseases

CLINICAL & REGULATORY STRATEGY for PRECISION MEDICINE

BBCR Can Meet Your Needs in the Ever-Changing Regulatory Environment

RWE for NATURAL HISTORY

RWE can be used to build Rare Diseases Natural History to support regulatory decisions

Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process.

Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements.

STREAMLINED CLINICAL DEVELOPMENT STRATEGIES

Strategic Clinical Innovation Organization

Our Strategic Clinical Innovation Organization (“SCIO”) method enables our clients to save time, create cost efficiencies, and reduce risk on the path to achieving optimal product market positioning.

Who We Serve

Small & Medium Sized Biotech Companies

  • currently moving from pre-clinical studies toward clinical trials
  • in need of interim Chief Medical Officer
  • in need of regulatory strategy consultancy
  • in need of preparing a pre-IND meeting with the FDA

 

Venture Capitalists/Investors

  • looking for a due diligence consultant in product regulatory strategy, safety, efficacy
  • seeking an investment opportunity in the biotech industry

Research, Pharma, or Biotech Companies

  • Rare Disease/Orphan Indication
  • Device/Diagnostics
  • Immuno-oncology
  • CNS
  • Biosimilars
  • Repurposing Drugs

THE PATH TO APPROVAL

Strategic Clinical Innovation Organization / SCIOnoun

def. 1. The strategic pathway for cost efficiency and risk management in clinical trials from pre-clinical to market. 2. The creation of a product-specific clinical/regulatory strategy as part of the IND or IDE and before tactical clinical activities start.

[Latin SCIO – to know, – to understand, – know how to]

The SCIO concept is the value proposition solution for cost-effectiveness and risk management in clinical development.

 

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“Integrity, excellence, and high appreciation of project’s needs as well as strategic solutions that are innovative and sustainable.”

– Jaime Uribe, Biotechnology Director – Probiomed

Let's Work Together

 

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