Issue link: https://www.e-digitaleditions.com/i/1517802
PharmTech.com Quality and Regulatory Sourcebook eBook March 2024 Pharmaceutical Technology ® 37 Regul atoRy SubmiSSionS search, can be jeopardized by poor data quality. En- suring data accuracy and reliability, therefore, is not just a regulatory requirement but a moral imperative for every clinical trial. Strategies for ensuring data quality and fitness With an awareness of common reasons for submis- sion failure and independent review of data and sta- tistical analyses, it is possible to improve chances of first-time submission approval. There are three key ways of doing this: • Study data conformance. Ensuring that FDA submissions meet CDISC and Electronic Com- mon Technical Document standards is critical. Many studies currently fail to meet these cri- teria, leading to f r ustration f rom reg ulator y bodies. A pre-submission review focusing on these standards can identify areas of strength, non-compliance, and necessary changes. • Data quality oversight. With the advent of ICH E6 (R2) addendum, new monitoring techniques such as centralized statistical monitoring are recommended. This approach involves using statistical analytics to identify and manage data integrity issues, thus improving the quality of clinical trial data. • Statistical approaches and inferential con- clusions. Adhering to the principles of ICH E6 (R2) is essential to ensure the integrity and fit- ness of data that significantly inf luence study resu lt s. Conduc t i ng sen sit iv it y a na lyses on data fitness issues helps assess their impact on study conclusions, thereby strengthening the submission package. The future of data integrity As the pharmaceutical industry evolves, so must the practices around data quality and fitness, ensuring that the highest standards are consistently met to maintain patient safety and public health. The com- mitment to data excellence lies in the ability to adapt and uphold these high standards of data integrity to not only streamline the regulator y process, but to also ensure that every submission ref lects the rigor and dedication inherent in drug development. ■ Adare Pharma Solutions ....................................................................................................................................................................................................................38 Ascendia Pharmaceuticals ................................................................................................................................................................................................................ 25 Blue Mountain ....................................................................................................................................................................................................................................23 Colbert Packaging ...............................................................................................................................................................................................................................29 Eurofins Lancaster Laboratories ...................................................................................................................................................................................................... 15 Ligand Pharmaceuticals .....................................................................................................................................................................................................................33 PDA (Parenteral Drug Association) .................................................................................................................................................................................................. 11 Seran BioScience ............................................................................................................................................................................................................................... 19 Simtra BioPharma Solutions .................................................................................................................................................................................. Opposite Cover, 3 Veltek Associates, Inc .......................................................................................................................................................................................................................... 5 Ad Index COMPANY PAGE As the pharmaceutical industry evolves, so must the practices around data quality and fitness.