Pediatric Clinical Drug Development (1)

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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.

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• 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.

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• 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
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• 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
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• 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
  QA sessions via chat
• Get certification of attendance.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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• 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_at_onlinecompliancepanel.com
8

• Get Connected With Us

www.onlinecompliancepanel.com
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com