Process Improvement

AdClin helps your data processing activities to find pragmatic and optimal solutions that match your company's focus in regards to FDA's expectations.

Adopt the AdClin SEM™, a simple yet powerful Software & Methodology Solution

With years of research and experience to its credit, AdClin has created a productive, secure and user-friendly software environment, including a version control system, and various tools to work faster with SAS®, while improving traceability.

This environment is highly controlled (any change is tracked) and the user can operate with fewer constraints, with the help of specific tools (e.g. SAS® log access is very friendly with links to errors and warnings).

AdClin also helps you build, expand and adapt the environment to your specific needs and constraint (e.g. CDISC® and/or FDA's requirements), and can provide related training.

Strategic/Technical Consulting & Auditing

AdClin helps your data processing activities to find pragmatic and optimal solutions regarding specific issues.

Typical issues:
  • If you are wondering how to bring your databases into compliance with new recommendations (e.g. CDISC® SDTM/ADaM).
  • If you are questioning the compliance of your computer systems with current regulations (e.g. CFR 21 part 11);
  • If you are wondering whether your systems are ready for the increased load that you forecast for your activities;
  • If you diagnosed inefficiencies in your current systems, but hesitate between several solutions (e.g. Implement new software? Upgrade your home-grown system? Deploy a custom system developed to fit your needs?); if in addition you wonder what the consequences in each case will be;
  • If you are not sure that your programming processes and techniques for data analysis are optimal, particularly for pivotal studies;

More generally, if you would like to better your data processing activities, but computer systems appear impeding, obscure or not totally under control…

We help you:
  • By conducting an inventory of your situation;
  • By establishing a clear summary of the options to consider;
  • By allowing you to choose what will best fit your financial, human and technical constraints, as well as your strategical plans.

We will follow through the setups of new commercial and/or open-source software if need be; or we can develop or have developed computer solutions that represent the best match between your current needs and the constraints imposed by existing software tools.

AdClin is a CDISC® registered solution provider.