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.
Project Management
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Maintain & QC Trial Master file (TMF)
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Vendor selection & management
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Project coordination
Data Management
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Annotated CRF specifications
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Preparation of Data Management Plan
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Database development
Grant Writing
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Grant proposal writing
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Promotional material writing/white paper
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Designing labels
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Report reviews/publication
Study Rescue/Salvage
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Assessments & QC monitoring
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Training for sites and staff
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Experienced SWAT
Regulatory Inspection Readiness
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Audit central and site files
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Conduct gap analysis & provide training
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Assistance pre-inspection, during and post