Quality Check your CDISC Data Submission Folder Before It Is Too Late!
This paper provides an overview of a SAS®-based tool to perform a final quality check on your CDISC data submission package which are not typically covered by either an existing CDISC datasets compliance tools or by commercially available eCTD publishing software. To download this white…
Importance of Niche Provider for Successful NDA Submission: Rescue Case Study
This paper outlines significant gaps identified in the deliverables provided by an outsourced full-service CRO, services offered to the Sponsor and lessons learnt through a case study on how the quality expectations and submission timelines were met. To download this white paper, please submit the…
Consider Define.xml Generation during Development of CDISC Dataset Mapping Specifications
This paper not only presents an approach to create the define.xml during SDTM specification and dataset development phase but also provides insights on how to use Pinnacle21 validator as a tool during the SDTM development lifecycle. To download this white paper, please submit the form…
Lead Programmer Needs Help: Dedicated Programming Project Manager to the Rescue!
This paper describes the distinct roles of a Lead Programmer and a Programming Project Manager, and the importance of having both for successful management of the study deliverables and the resources. To download this white paper, please submit the form below and we will e-mail…
Building Efficiency and Quality in SDTM Development Cycle
This paper helps the programmer to understand the compliance requirements upfront and implement those during SDTM mapping specifications development. To download the this white paper, please submit the form below and we will e-mail you the link.