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CLINICAL DEVELOPMENT:
• Prepare Clinical Development Plan
• Clinical trial study design
• Biostatistics
• Protocol design and preparation
• CRF design
• IB preparation
• RFP preparation and study site selection
• Custom Database Development
• Medical writing, preparation of grant applications
PHARMACOLOGY/TOXICOLOGY:
Arujet can provide an array of nonclinical
pharmacology-toxicology consulting services that span the entire
biologic/drug development process, from discovery through marketing
application and approval. At the early stages of biologic/drug
development, Arujet Pharmaceuticals will review the product information,
conduct a gap analysis, evaluate completed studies and after considering
the product class, proposed indication and mechanism of action can
provide an appropriate nonclinical plan for development through marketing
application.
PRODUCT DEVELOPMENT PLANNING:
Product Planning is critical to the success
of the new product and the sponsor company. A well-conceived and
comprehensive product plan provides a detailed assessment of your product
and the most effective pathway to market or licensure.
REGULATORY SUPPORT:
Arujet Pharmaceuticals can provide assistance in
reviewing and evaluating data and responding to questions during pre-IND,
IND, and BLA regulatory interactions.
CUSTOM DATABASE SYSTEM DEVELOPMENT:
We specialize in system
development, custom programming, and client-server database design and
implementation.
Arujet Pharmaceuticals can design, configure,
install, manage, operate and support in-house databases and database
management systems providing a wide range of business functions.
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Bina Tejura, MD
Bina Tejura, MD has 10 years of industry experience in the development and post-marketing support of drugs, biologics, and diagnostics.
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