Standards



Data standards
Follow CDISC standards, SDTM and ADaM
Adopt client standards if requested
Reveiw raw data specs and structure with CDASH (CRFs, CRF annotations)

 


TLG standards
Follow ICH and CTD standards for content, format and layout

Adopt client internal standard layout
Follow client standards and per SAP

 


Medical Writing Standards
Follow ICH and CTD standard format
Adopt client specific standards

 

 

SOPs

Client’s SOPs and Guidelines are often followed although we have internal SOPs and Guidelines for all the activities as well

Client’s requirements are incorporated into the processes and procedures for each project. We will work with the client to define the best approach based on the existing working practices of both parties

 

Validation Processes

1. Define three levels of validation:

  • re-programming: DDS (SDTM, ADaM), key TLGs
  • selected numbers: secondary TLGs
  • independent review: listing package

2. Generating TLGs and team review:

    At least three times: draft, blinded, locked

 

3. Documentation - Final output release form:

    Compile, check and sign the list of all SAS programs and corresponding outputs for archive by the developer and validation programmer.