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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
Biostatistics and Programming
Medical Writing
Strategic Consulting
Project Management


Data Management    Back to Top

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    Back to Top

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    Back to Top

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    Back to Top

Veristat has the experience to provide high level strategic consulting services ranging from study design to submission strategies.

Project Management    Back to Top

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.

 

 

 







Veristat Inc., 356 Washington Street, Holliston, MA 01746
Phone: (508) 429-7340 | Fax: (508) 429-5741
Copyright 2006