Selection, Care, and Feeding of the Investigator Site
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Instructor Profile:
Stephen Schwartz – CIC 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. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Description: Investigators who are committed to the sponsor's program objectives and to the protocol are more likely to produce a successful study site. Clinical Research Coordinator (CRC), who share this sponsor relationship are more likely to produce compliant, quality data within the expected study period. Sponsors want investigators and CRC that are personally committed to their programs. Investigator and CRC cooperation and communication provide sponsors with oversight on the performance of the study, independent of CRO or CRA reports. This enables prevention, early detection, and timely positive resolution of the inevitable challenges incurred in the conduct of a clinical trial. The sponsor does not want a PI to be practically invisible. The use of a CRO CRA does not necessarily disable this site/sponsor relationship. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Why Should you Attend? Attend this webinar to learn about: How to use the pre study qualification site visit, the initiation site visit, and the study contract to set expectations of site performance. Which sponsor regulatory sponsor obligations can be delegated to the CRO; and the effect of inappropriate CRO delegation at the study site. What works and what does not for a communication plan; did you include the PI and CRC? How to use the CRO as a tool, not a sponsor substitute. Sponsor functions that promote site compliance, cooperation, sponsor oversight of CRO activities at the site. Early termination - how to make it an acceptable option for the investigator. The critical function of the site/sponsor relationship in determining appositive regulatory inspectional outcome.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Objectives of the Presentation: This webinar will present examples of successful and failed investigational site performance relevant to the quality (or lack thereof) of the sponsor relationship to the sites. Sponsor procedures that enable and disable site/sponsor relationships (and may compromise site performance) will be discussed.
Who can Benefit?
Project managers CRA Investigators CRC
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Live Session - How it works?
Username and Password will be sent to you 24 hours prior to the webinar Presentation handouts in pdf format will be mailed to you Login to the session using the username and password provided to you Get answer to your queries through interactive Q&A sessions via chat Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Recorded Session - How it works?
A link will be provided to you upon purchase of the recorded session Please click on the link to access the session Presentation handouts in pdf format will be mailed to you Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com