MCRA’s unique clinical services
enable international and US-based orthopaedic companies of all sizes
to successfully execute a clinical study. As clinical affairs should
be integrated with regulatory and reimbursement initiatives, MCRA’s
integration is perfectly positioned to optimize quality, cost, and
time.
MCRA uses dedicated and experienced
clinicians to actively manage CRO’s, statisticians, investigators
and IRB’s, leading to faster enrollment and ultimate success.
Furthermore, MCRA’s clinical team is adept at writing whitepapers
and other clinical publications.
MCRA’s clinical expertise,
coupled with our global surgeon relationships, makes MCRA a valuable
musculoskeletal clinical service addition to any company.
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Clinical Study & Regulatory Submission Preparation
- Study Protocol & Budget Development
- Retrospective Clinical Data Compilation
- Literature Searches & Analysis
- Investigator Selection
- Compile IRB Packets, Coordinate IRB
Approvals,Compile Investigator Brochures, & Creation Consistent
Case Report Forms
Clinical Study Management
- Manage Data Entry & Analysis Through
Subcontract to a CRO
- Manage Site Trainings & Monitor
Site Status Reports
- Negotiate IRB Approvals
- Perform Study Statistics Analysis
- Write Final Clinical Study Report for
Submission
Post Clinical Studies
- " Ghostwriting" for Peer-Reviewed
Medical Journals, Whitepapers, PowerPoint Presentations &
Abstracts for US & International Medical Conferences
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Regulatory
- IDE/PMA, IND/BLA, HDE and/or 510(k)
Protocol Development
- Clinical Data & Literature Search
Analysis
Reimbursement
- Integrating Healthcare Economic Data
Within Clinical Study Protocols for Future Coding Purposes
- Sponsor Health Economic Outcome Studies
Intellectual Property
- Redesigns & Improvement of Implants
& Instrumentation
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The true value of MCRA is the integration of 5 business value creators
– orthopedic regulatory, reimbursement, clinical, intellectual
property and quality assurance. MCRA places particular emphasis on
working with companies at all stages of development, whether they
are single-product companies or companies with several thousand technologies.
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CLINICAL
BROCHURES
CLINICAL LEADERSHIP & ACCOMPLISHMENTS
Director, Clinical Affairs:
Aviva Barber
View Full Biography
Director, Clinical Trial Affairs:
Teresa M. Schroeder
View Full Biography
Team Accomplishments
LATEST CLINICAL NEWS
July 2008 - The Gray Sheet
Expectations For Artificial Disc Trials Challenge Market Hopefuls
Read More
11/29/06 - MCRA, LLC Names Teresa
M. Schroeder as Director, Spine Clinical Affairs
Read More
CLINICAL WHITE PAPERS
View Text
View PDF
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Musculoskeletal Clinical Regulatory Advisers, LLC is the leading neuro-musculoskeletal / orthopaedic consulting firm assisting established and emerging companies in the development and commercialization of their technologies. MCRA’s consultants are industry leaders who support Clinical, Regulatory, Quality Assurance, Reimbursement, Intellectual Property, and Healthcare Compliance initiatives. MCRA’s integration of these key value creating initiatives, as well as its focused specialization, creates unparalleled expertise to its clientele. |
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