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Services
Veristat offers an array of services to assist it's clients with
the clinical development process. We start each process and procedure
with the end result in mind. Veristat offers services in the following
technical areas:
Data Management
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Veristat data management services for paper-based
trials include database design, setup, entry, verification and validation.
We provide medical coding using MedDRA, COSTART, WHOART, WHODrug.
Veristat's relationship with leading EDC
providers allows us to offer a streamlined approach to data collection
via the internet.
Biostatistics
and Programming
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Veristat offers a variety of services in Biostatistics and Programming
including:
- Sample Size Calculations
- Randomization Lists
- Statistical Section for Protocols
- Analysis Plan Development
- Statistical Report Writing
- IND Safety Updates
- FDA Representation
- Statistical Programming using SAS®
Medical
Writing
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Veristat medical writing services offered on a study-specific basis
include production of clinical study protocols and amendments, sample
informed consent forms, case report forms, and clinical study reports.
On a program-specific basis, Veristat medical writing services offered
include preparation of pre-IND and IND documents, FDA briefing documents,
and clinical sections of NDAs, including the CTD format.
Veristat medical writing personnel also have experience in the
preparation of abstracts for professional meetings and slide presentations
for FDA Drug Advisory Committee and other regulatory meetings.
Strategic
Consulting
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Veristat has the experience to provide high
level strategic consulting services ranging from study design to
submission strategies.
Project Management
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Veristat project management services focus
on the technical aspects of the clinical development process. We
have assisted clients in the management of data management, analysis,
reporting and regulatory filings.
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