Real World Evidence
The failure to identify data integrity issues presents a substantial business risk. Data integrity gaps can result in withholding approval of a pending application and extend to all marketed products, eliminating market access and restricting revenue. Increased information sharing among other regulatory authorities could further compound the impact.
Here you can access the latest articles and resources developed by PAREXEL Strategic Compliance experts, including an overview webinar on key data integrity issues in the pharmaceutical industry.
Further curated content on key issues in strategic compliance will be added over the coming weeks - please check back for further materials.
Data Integrity Issues in the Pharmaceutical Industry
On-demand webinar presented by David Chesney, Vice President and Practice Lead, PAREXEL Consulting
Data Integrity Déjà Vu
Article by James P. Stumpf, Principal Consultant, PAREXEL Consulting & Mark A. Lynch, VP Management, PAREXEL Consulting
An outline of how to prepare for inspections on data integrity, with an overview of recent data integrity initiatives and examples of violations.
Data Integrity Déjà Vu? Click here to find out more.
Regulatory Handbook - Data Integrity: FDA and Global Regulatory Guidance
By Dr. Siegfried Schmitt, Principal Consultant , PAREXEL Consulting
An outline of applicable FDA and global regulations, guidance and reports on data integrity.
Strategic Compliance Factsheet
Learn how PAREXEL regards compliance and quality management as a critical business issue, and how a coordinated, expert approach to both activities can bring return substantial ROI.
Click here to download the factsheet.