Auditing
Sometimes it just makes sense to talk to people who have “been there and done that.” In pharmacovigilance, that’s Sentrx.
We know more than a little about audits ourselves because our services are regularly scrutinized and frequently subjected to audits examining our validation methods and compliance performance. This has given us a unique insight into structuring audit services. You’ll find our auditors knowledgeable, well prepared, professional, fast and easy to work with, and an asset to your operations.
A Sentrx audit can help you identify inefficient processes, discover gaps in training or development, and determine safety system technology improvements. We can look at single case processing or aggregate reporting systems, examine safety structure and strategy, and help with partnership agreements or provide diligence assistance. We’ll provide a comprehensive, well-written assessment of our findings, a recommended action plan built around areas of greatest risk or vulnerability, and specific and realistic suggestions for change. Our suggestions are based on more than 15 years of processing cases and supporting the full scope of PV for clients of all sizes and types. We provide a stimulating combination of regulatory insight along with a thoughtful assessment of your safety strategy, infrastructure, personnel, operations, and processes. We also include a thorough review of your drug safety systems and technologies.
Our auditing expertise flows from the experienced staff of our quality standards group, which brings you a proven audit history of direct involvement in over 200 audits during the past five years. We have experience in all types of audits, including vendor, sponsor, and regulator for the MHRA, EMEA, and FDA. When needed, we bolster our audit team with a proven group of auditors familiar with Sentrx’s quality standards.
A comprehensive and objective look at your entire process can make a tremendous difference in your operational efficiency. When you’re ready to take the step, talk to the experts. Talk to Sentrx.
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Doreen Lechner, PhD EVP Pharmacovigilance Client Services |
