Stephen Schwartz - CIC
Founder, Solaris Research Corporation
Founder of Commonwealth Clinical Research Services (later as Solaris Research Corporation), a full service CRO from 1989 to 2009. He has a degree in microbiology/infectious disease. Steve worked in clinical project development for Pharma for 16 years and for 20 years as a CRO with experience in devices, biologicals, diagnostics, and therapeutics in most of the areas of clinical research for all study phases, as well as pre-clinical activities.

Steve has extensive field experience as a CRA and as a CQA auditor, He has expertise in Clinical Operations, including the functions of clinical monitoring, program management, product development, CQA, and inspectional operations. He has recently retired from Pharma where he was Sr Manager, Global Clinical Operations. His current activities as a consultant include CQA inspections and training, Gap Analysis Audits, and Clinical Project Oversight.

Steve has served on an IRB and has served as PI on several phase four studies. He has published a monthly international clinical trial conduct newsletter (2000-2008) and has been a frequent presenter of webinars, and seminars over a broad range of topics for FDA News and Thompson Publishing and Bioforum. GCP, Regulatory, and CQA training of academia, government (US and Canada), and pharma staff have been a large part of his activities since 1994.

His many years of experience and expertise and his interactive presentations enable participant interaction and exchange of information/options.
Upcoming Webinar
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Recorded Webinar
Surviving an FDA Sponsors Inspection - Training for success
FDA investigators (auditors and inspectors) are thoroughly trained in interview methods that will yield clues to GCP non-compliance, the sources of the non-compliance, the documentation of the non-compliance, and the sponsor’s intent (presence of misconduct or fraud) in the conduct of the non-compliance.
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Fundamentals of the new FDA inspectional record requirements for EDC and EDE clinical trials
This webinar deals with basics of new FDA inspectional record requirements for EDC/EDE clinical trials. Case history of multiple site trial that uses EDC to be presented. For electronic record function procedures, changes might be possible to remain in compliance with the compliance inspectional standards.
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How sponsors generate GCP noncompliance at their investigator sites
This course will demonstrate that many of the 21 most common FDA observations of noncompliance at investigator sites relate, not only to the investigator, but directly to sponsor clinical research and clinical operations procedures. Multiple case history examples will be discussed. Many of these observations of noncompliance could have been prevented or remediated by appropriate sponsor procedures if they had been applied to the investigator's conduct of the clinical trial.
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To file or not to file an NDA Application: When GCP Noncompliance Compromises your Pivotal Trial
Risk management is the operative system in the pharmaceutical product development process. GCP Non Compliance at the investigator site remains the sponsor’s primary liability for the rejection of the regulatory application. Fifty percent of all FDA study related investigational site inspections incur some level of GCP noncompliance observations.
Recorded Session Get life time access for one participant with download option!

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