Moorpark, CA – 10 March 2018 – Jamie Colgin, President of Colgin Consulting, Inc. and Principal Consultant, Validant, will be a featured expert panelist for the Food and Drug Law Institute’s (FDLI) live webinar entitled “Data Integrity: FDA Enforcement and Risk-Reduction Considerations.” The webinar takes place on Tuesday 13 March 2018 from 2:00 to 3:30… [Read More…]
When is a CRO not a CRO?
(And why does that make enforcement hard?) What do the following companies have in common? Electronic data capture (EDC) software providers Central image / electrocardiogram (ECG) / spirometry readers Central clinical labs Electronic patient reported outcome (ePRO) software providers They’re not Clinical Research Organizations. That’s right. They’re not CROs. When you finish this, you’ll be… [Read More…]
Why Do UAT On Service Provider Systems?
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…]
New FDA Q&A on Data Integrity
On 5 August, FDA published a new set of 7 questions and answers. 3 questions cover data integrity and e-signatures. While the Q&A target GMP, there are lessons to be learned for all of us: Maintain the electronic records created by instrument systems used for your GLP and GCP studies – paper printouts are not… [Read More…]
