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SERVICES

Regulatory Strategies & FDA submissions

Clinical Trials: Design & Supervision

Funding Strategies & Applications

Marketing and Basic Science

Morphometric & Imaging Solutions

Histopathlogy Lab

Biostatistics

PROJECTS & PUBLICATIONS

Services

Because we are introducing innovative technology, each project requires a customized approach. Please review the services provided by BMC, Inc., below. Then, Contact us for a free personalized consultation.

REGULATORY STRATEGIES AND FDA SUBMISSIONS

There are a myriad of pathways through the FDA approval process. We can help chart a practical and efficient course through the complex and often confusing FDA maze.

CLINICAL TRIALS DESIGN AND SUPERVISION

BMC, Inc. can assist with any or all aspects of conducting medical device clinical trials

Poll FDA for safety and efficacy issues
Design of clinical trials
Performance site and physician-investigator selection and training
Institutional Review Board documentation
IDE applications to FDA
Written protocol, data collection forms and other documentation
Monitor clinical trials
Data collection, statistical analyses and interpretation
PMA and 510(k) applications to FDA.

FUNDING STRATEGIES AND APPLICATIONS

BMC, Inc. can provide access to Bay Area Venture Capital.
BMC, Inc. can assist with the preparation of NIH SBIR/STTR applications and help you find University partners for STTR projects.
Proposal preparation for the funding agency of your choice.

MARKETING AND BASIC SCIENCE

Understanding the mechanism of action of your device can provide a significant market advantage. BMC, Inc. will design basic science studies to compliment your marketing objectives. Well-designed controlled studies can also improve your product's, safety, clinical efficacy and ergonomics.

If the mechanism of action is unknown, we will research your device and suggest a working model and testable scientific hypotheses. Because of our academic affiliations with over 20 Universities and Medical Centers, BMC, Inc. can identify and plug-in to related ongoing research programs for cost-effective basic science studies. Also provided are manuscript preparation and submission to peer-reviewed journals, and presentations at scientific/medical conferences.

MORPHOMETRIC / IMAGING SOLUTIONS

Histological reconstructions
Tissue morphometrics
Analysis of radiographic densities
Light, fluorescence and electron microscopy
IR imaging
Endoscopy
Medical illustrations and diagrams

HISTOPATHOLOGY LAB

BMC, Inc. offers a full service histopathology laboratory. Our Laboratory prepares histological tissue specimens for pathological microscopic examination. Hospitals, clinical laboratories and biotechnical research facilities are provided with quick, reliable and professional service. All of our technicians have over 20 years experience in histology. We carry a large stock of immunohistochemical stains along with an extensive assortment of standard histological stains.

We accept everything from GLP (Good Laboratory Practice) work to routine preparation and H&E staining.

On-site tissue harvest, documentation, photography
Tissue blocked, sectioned, stained and mounted on microscope slides
Histologic and pathologic interpretation
Microscopic (light, fluorescence, EM) photography

BIOSTATISTICS

Based upon experience with several successful clinical trials, we have determined that collaboration with an experienced statistician during the early planning stages, rather than at the end of the trials, allows their expertise to influence the decision-making processes, promotes cost-effectiveness and adds an important measure of quality control.

AT THE PLANNING STAGE. In the beginning of any successful clinical trial, the statistician's input is key:

Design, analysis and interpretation of animal or pilot studies
Sample size estimation for clinical trials
Identification of appropriate measurement techniques
Selection of appropriate study design
Design of data entry forms
Initiate a dialog with the FDA statistician.

DURING THE STUDY. The statistician's expertise is needed during the study as a control measure in many areas:

Assure and monitor accurate data collection
Establish data base - oversee data entry and quality assurance
Provide interim results
Evaluate the effects of any changes in protocol.

AT THE END. The statistician's obligation is to perform appropriate statistical analyses and provide:

A concise report with objectives, hypotheses, descriptions of methods and variables
Discussion of results with clearly presented tables, charts and graphs
Explanations and conclusions, in a format comprehensible to both laymen and scientists
Written clinical reports for FDA submissions
Interaction with the FDA statistician during the review process.

BMC FACTOID: "Meaningless statistics were up 3.4% last month.