Managing Clinical Investigator Site Inspections: Key Strategies for Success
By Nuno Pires (Director, GxP Strategy) and Ernesto Vera Sanchez, MD, MPH, PhD (VP, Department Head, GxP Strategy) In our previous blog, “Inspection-Readiness: What You Need to Know to Prepare for a GCP Inspection”, we explored the broader concept of inspection-readiness, emphasizing the importance of adhering to Good Clinical Practice (GCP) guidelines to ensure overall compliance […]
Inspection Readiness: What is it, why it matters, and what you need to know to be prepared
Organizations must have inspection readiness since inspections can be unannounced or come at any time. Good Clinical Practice (GCP) inspectors use different approaches depending on the regulatory authorities for which they represent; however, all of them will verify the compliance status on GCP and other applicable regulations during the inspection. Planning ahead to anticipate all processes are compliant means an organization […]
Inspection-Readiness: What You Need to Know to Prepare for a GCP Inspection
By Ernesto Vera Sanchez, MD, MPH, PhD (VP, Department Head, GxP Strategy) The International Conference on Harmonization/Good Clinical Practice E6 (ICH GCP) lays out clear expectations for both the sponsor and investigators for compliant trial conduct. These guidelines cover compliance with GCP and with the applicable regulatory requirements to ensure that procedures related to clinical trials […]
Strategizing for Your Submission: Planning Ahead for Your NDA or BLA
Pharmaceutical marketing applications, whether a new drug application (NDA) or biologic licensing application (BLA), are massive undertakings. They can contain tens to hundreds of thousands of pages of documents. Therefore it behooves a sponsor to plan such an application well in advance. Often planning for the application is postponed until the pivotal Phase 3 clinical […]
Getting your ducks in a row: Successful Management of Large eCTD Submissions
Original Air Date: Wednesday, November 6, 2019 Time: 10 am (EST) | 7 am (PST) | 3 pm (CET) Once gap-analysis of your marketing or investigational new drug application has been completed, Cato Research recommends that planning for the submission of the eCTD application begin. While many companies treat the actual compilation and submission of […]