Conduct audits of clinical trial facilities and/or clinical trial activities (including site study files) to ensure investigators and their staff observe Good Clinical Practices as well as the Declaration of Helsinki and industry driven good documentation practices. Provide consulting services to assist with answering FDA-483 citations, as well as evaluating or setting up internal quality systems. We can assess your facilities and help you prepare to conduct your first clinical trial. We provide 100% clinical quality assurance support to sponsors, CROs and clinical investigators!
To ensure you are ready for a regulatory agency inspection, the following is our focus:
Auditor's expertise includes Analytical and Clinical Laboratory audits. A review of test methods, validation, reagent and reference standard maintenance, documentation and other laboratory quality systems are a major focus.
WQATS staff has conducted GCP, GLP, and cGMP audits in 23 countries worldwide including the United States, Russia, UK, Bulgaria, Poland, The Netherlands, Spain, Israel, Turkey, Canada, and many more. We help companies avoid lengthy delays and millions of dollars lost due to non-compliance issues.
Compliance is dependent on education and experience. Employees must know applicable GxP Regulations and ICH Guidelines to ensure compliant procedures and processes are implemented and maintained.
WQATS have written numerous articles and presented at several professional organizations. Additionally, experience includes developing training programs, writing standard operating procedures to ensure training is properly completed
SOPs are like business plans. They allow companies to be consistent with their practices and learn quickly what works or doesn’t work; yet many companies are short on procedures that describe their daily activities. Most companies hit the ground running, focusing 90% of their attention on manufacturing and testing or conducting clinical trials.
Written procedures are good business sense and required by some regulations. If you’re operating without them, you may already be out of compliance! We will gladly help you achieve this regulatory requirement at an affordable price.
WQATS offers a comprehensive online Good Clinical Practices (GCP) and Good Clinical Laboratory Practices (GCLP) test to help you prepare for your certifications. The test consists of more than 200 randomly selected questions and is designed to simulate the actual exam given for your certification. Questions are taken from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidance documents, European Union directives and Canada and US FDA Food and Drug regulations. For a minimum cost, you can make sure you are absolutely ready before taking your exam to become a certified clinical investigator (CCI), certified clinical research associate (CCRA), certified clinical research professional (CCRP) or certified clinical research coordinator (CCRC). Best of all, you can take it as often as you like for three months.
Each practice tests comes with a Certificate of Completion that can be used for annual GCP/GCLP training.
WQATS can supply the information required for you to make sound business decisions and deliver your product to market on time! If you require internal or external auditing services that are reliable, thorough, timely and cost effective; if you want services that provide quality you can count on…. let WQATS give you a helping hand.