CLINICAL RESEARCH

BCI operates as a full-service clinical research organization. We support 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, as well as the impact that accurate, quality clinical research results can have on the future of medication and treatment for many therapeutic areas.

CLINICAL TRIAL
MONITORING

BCI can provide clinical trial monitoring for your organization. With a team of fully trained professionals, we can manage your clinical trials from start-up through phase Phase I-IV trials. We also offer complete training and ongoing support for new physicians and study coordinators. Whatever the need, we have the expertise and the resources to support your needs, no matter how varied or complex.

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

LINKS
CONTACT US

mail@bracaneco.com

Ph. 888-568-4271

Local: 469-814-0658

Fax: 972-727-6239

1201 W. 15th St. Suite 330
Plano, TX 75075
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