XTiers Consulting, Inc.
12215 Greenbriar Branch Dr.
Potomac, MD 20854
Tel: 240-476-1784
Fax: 301-983-6307
Email: yzhang@xtiers.com
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Services
Services and deliverables
XTiers provides include, but not limited to, the following:
Clinical Trial:
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Phase 1-4 protocol development and review, especially
for endpoint selection and statistical methodology
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Case Report Form (CRF) development and review
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sample size calculation and power analysis
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randomization schedule
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statistical analysis plan (SAP) and templates
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tables/figures/listings (TFLs) and CRF panel/profile
tabulations ready to be dropped in MS Words documents.
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statistical interpretation, validation, and audit as
well as planned interim or ad hoc analysis.
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ICH-compliant clinical study report (CSR)
Data Management and Database Maintenance:
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SAS-based full data management for small trials (i.e.,
Phase 1 clinical pharmacology studies)
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single-trial database design and standardization (see
Data Process)
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multiple-trial database integration and cross-validation
against individual databases (see
Data Process)
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clinical laboratory data conversion and standardization
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adverse event preferred terminology coding,
within-product standardization (e.g., COSTART to MedDRA), and
within-dictionary upgrade
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product database maintenance, warehousing and mining
Product Pre-Marketing and Marketing Registration:
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Investigator’s Brochure (IB) development
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Investigational New Drug (IND) application clinical
sections
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New Drug Application (NDA) clinical sections (or in the
CTD format) and safety updates
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Integrated summary of clinical safety (ISS) and efficacy
(ISE), bio-equivalence (BE), and stability analysis
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ISS and ISE results cross-validation against individual
CSRs
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NDA SAS dataset and documentation preparation
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NDA Section 11 (or Module 5.3.7 in CTD) preparation
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Responses to FDA reviewers’ questions
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Attend meetings with regulatory authorities on behalf of
clients.
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