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CLINICAL RESEARCH

Bracane Company supports pharmaceutical, biotech, and medical device companies to execute clinical trials for Phase I-IV. Our services include site qualification, study initiation, clinical monitoring, data and site management, and regulatory compliance. BCI also specializes in audits, study rescue and inspection readiness. Click for more information.

Service Details

CLINICAL RESEARCH CONSULTING

We are knowledgeable of FDA regulations and understand the values that this intellectual capital brings to the industry. We support clients navigate the landscape to regulatory approval.

CLINICAL TRIAL
MONITORING

With a team of fully trained professionals, we can manage your clinical trials from start-up through phase Phase I-IV trials. 

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ADDITIONAL SERVICES

SUBMIT REQUEST FOR PROPOSAL

Project Management

  • Maintain & QC Trial Master file (TMF)

  • Vendor selection & management

  • Project coordination

Data Management

  • Annotated CRF specifications

  • Preparation of Data Management Plan

  • Database development

Grant Writing

  • Grant proposal writing

  • Promotional material writing/white paper

  • Designing labels

  • Report reviews/publication

Study Rescue/Salvage

  • Assessments & QC monitoring

  • Training for sites and staff

  • Experienced SWAT 

Regulatory Inspection Readiness

  • Audit central and site files

  • Conduct gap analysis & provide training

  • Assistance pre-inspection, during and post

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