Outsourcing services is quite common in clinical development. We outsource everything… Lab analysis of subject samples (central clinical labs) Interpretation of subject medical images (central imaging readers) Data capture at clinical sites (EDC and ePRO) Randomization and management of investigational product (IVRS/IWRS) Trial master files (eTMF) …and the list goes on and on…. [Read More…]
How Do I Apply ALCOA To E-Records?
It’s easier than you think! Let’s Start with a paper record example Explore how to apply ALCOA to electronic records Point out 3 warning signs on the trail to data integrity ALCOA in the paper world ALCOA defines the generally accepted standard for GLP and GCP data quality and data integrity. Let’s use paper CRFs at a clinical investigator’s… [Read More…]
The 4 KISS Principles of Computer Validation
If you’re like most people, you resolved to lose weight this year. Eat less; exercise more; lose weight. Simple, right? Yes, but not easy! Computer system validation is like that – there are 4 simple principles behind it. In fact, they’re so simple, I call them Stupid Simple. If you avoid auditing computer systems, listen up!… [Read More…]
