Clinimetrics offers a comprehensive range of consulting services to assist
our clients in developing the full potential of their products, whether in
pharmaceuticals, biotechnology or medical devices. Our senior management
staff and corporate affiliates are uniquely qualified to provide a broad
range of assistance in the design and implementation of product development
programs. We are available to work with you to define the clinical
development and regulatory strategy, whether your product is a new chemical
or biological entity, a medical device, or a DSHEA nutritional supplement.
We offer several options for services and consultation in areas such as:
Protocol development/Clinical Program Consultation
Using existing regulatory development guidelines, therapeutic specialists,
clinical advisors and intelligence reports on similar studies, Clinimetrics’
staff and affiliate MD's, Regulatory Specialists and Statisticians will
provide optimal study design and clinical implementation parameters to
ensure your study results in targeted label claim objectives. Our goal is to
achieve early results with minimal cost and yet ensure quality statistical
and clinical standards in your development project. Similarly, our Medical,
Regulatory, Statistical and Project Management staff and affiliates will
design and propose a development strategy for your product that will ensure
the proper dose selection, safety quantification and proof of efficacy in an
efficiently designed program to provide you with valuable data in minimum
time and cost.
Biostatistical Consultation
Our Statisticians have experience in the design and analysis of highly
complex clinical trials. They are available to work with our clients in the
study design stages, in interim analysis situations if needed and in the
final statistical analysis and reporting stages of successfully completed
studies.
Regulatory Strategy
Our Regulatory Affairs team is composed of individuals with
extensive pharmaceutical and device development experience,
covering a wide range of therapeutic areas and types of
submissions. We offer customized, regulatory solutions
throughout every phase of product development, review and
commercialization. We are available for sponsor representation
with FDA or other regulatory agencies around the world.
Product Portfolio and Management Services
A strategic team will evaluate your patent position, perform ROI analyses
and develop the integration of CMC and non-clinical services, to draft a
lifetime strategic development plan. This plan doubles as both your roadmap
for development as well as an investment tool.
These high end product development services are a hallmark of the quality work we perform at Clinimetrics.
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