Adam de Neergaard discusses solving the challenges of manual processes and Excel Sheets

Implementing CDISC Standards

Since the adoption of the CDISC standards began 20 years ago, Pharma companies have been struggling to implement clinical standards across the organization. Due to the lack of standard systems, the industry has, over the years, implemented manual processes, custom developed solutions and multiple Excel sheets to be in compliance with the increasing regulatory requirements.

This article specifically focuses on how we solve the challenges of managing, controlling and sharing your Sponsor and CDISC Controlled Terminologies. If you have experienced your organization spending too much time manually maintaining multiple Excel sheets or custom legacy systems, I hope this article and our recorded webinar (details of how to access the webinar are at the end) can inspire you to take the next steps.

Industry challenges and the A3 Terminology MDR

Working with sponsor companies over the years and, specifically, the recent engagement with the Sanofi standards group, we learned that sponsor companies in general are facing similar challenges:

Challenging CDISC and Industry Issues

General Industry Challenges Using Excel

Challenging CDISC results in

Those challenges lead to these important issues

In collaboration with Sanofi, we developed our 2nd generation A3 Terminology MDR to meet the industry requirements for automation, leading to increased consistency, efficiency and quality.

Besides the general benefits of having a validated SaaS solution (i.e. higher security, scalability, audit trail, version management, workflow etc), in our recent webinar we demonstrated some of the key features that addresses the industry challenges and collectively improves your standards management process (if you want to see the webinar, details are at the end of the article):

  • Manage your Controlled Terminologies in a central platform, that is always be up to date with the latest CDISC version
  • Search, compare and view changes across all of your CDISC and Sponsor Terminologies
  • Impact assessment and automatic upgrade of code lists
  • Different user roles enabling you to share your standards with stakeholders without compromising data security
  • Standard APIs for better insight and use of standards

You may have systems and processes in place that require your terminology to be in either Excel or other formats. With that in mind, the system is able to export to your required format at the press of a button.

Solving CDISC Challenges

High Level Process Diagram

How fast can you get going?

We acknowledge that the task of updating internal documentation and processes when changing existing systems within the Life Sciences industry can be overwhelming. To ease the implementation, we have developed a quick and easy package that will have you up and running in 5 working days.

In addition, we have learned that a successful implementation is about both People and Technology. People are the most important asset you have and ensuring they are quickly able to adapt to new ways of working is vital. So we offer support to get your organization started by running change management workshops and training sessions. In addition, we can QC and import your current terminologies. To minimize impact on your current downstream processes, we can export your data as well.

A3 Terminology MDR challenging CDISC

The A3 Terminology Standard Implementation Package and optional services

 

What next?

If you want to learn more and see the system in action, get in contact with me, Adam de Neergaard (adn @ s-cubed.dk) and I can arrange a demonstration. If you want to watch the webinar, again just drop me an email and I will ensure you get all the details you need to login to the recording. And don’t forget, we will be at the CDISC Interchange next week. Join us on the stand and find out more!