Processes and Procedures:



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.  

 

 

Timelines

We follow Client's timelines for all the deliverables. Our internal defined timelines are listed below:

 

From

To

Time

Protocol/CRFs

Draft SAP

4 - 6 wks

SAP, Data

Draft TLGs

8 - 16 wks

DB Close

Key TLGs

3 days

DB Close

Complete TLGs

2 wks