ICH E6(R2) Benchmark Survey: Essential Elements of Compliant CRO Oversight

Clinical Trials, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • October 27, 2016

This webinar will showcase the results of Comprehend’s 2016 ClinOps ICH E6(R2) survey and its impact on the CRO/Sponsor relationship.

In Comprehend’s previous 2016 survey of 300 global ClinOps leaders, 81% noted that meeting their milestones was their number one priority. Yet, only 22% respondents were confident that their CRO will achieve milestones on time and 92% stated it was due to the inability to investigate in real time.

In Comprehend’s subsequent survey, they benchmarked the essential elements of a compliant ICH E6 (R2) CRO Oversight program. The speakers will present results from questions such as:

  • What are your plans for training and implementation of ICH E6(R2)?
  • What are key elements of your CRO Quality Agreements and Oversight Plans?
  • Which technologies ensure real time investigations with your CROs?
  • What Quality Risk Management initiatives are you funding?

The 2016 ClinOps ICH E6 (R2) survey put the spotlight on CRO Oversight and the need for real time investigation, decision-making and collaboration. ICH E6 (R2) is meant to encourage more efficient approaches to clinical trial design, conduct, oversight, recording and reporting. It also updates standards regarding electronic records and essential documents. The new guidance specifically highlights the need for Sponsors to ensure CROs are accountable for all responsibilities transferred to them. Comprehend’s 2016 ClinOps ICH E6 (R2) survey will give you insight into your peers’ preparedness and how they are closing the gap.

Keywords:

Speakers

Bruno Gagnon, B Pharm, MSc, Clinical Intelligence Expert

As a 25-year industry veteran, Bruno was formerly the VP Clinical Operations for BioMarin. Bruno now spends most of his time as an Executive Consultant leading Clinical Operations in emerging life sciences companies. He is also on Faculty at San Francisco State University in the Clinical Trial Design and Management Certificate Program.

Matt McKinney, Clinical Intelligence Expert, Comprehend Systems

Matt McKinney is currently a Sr. Sales Engineer with Comprehend Systems. Prior to Comprehend Matt spent seven years with Medidata Solutions as a Sr. Business Consultant. Matt has deep eClinical Industry experience and has a passion to help bring safe and effective treatments to market to serve the patients who need them the most.

Who Should Attend?

Clinical Operations and Data Management Professionals

  • Clinical Trial/Clinical Study Management
  • Clinical Data/Informatics/IT
  • Clinical Outsourcing

Clinical Research, Technology and Business Professionals

  • Biometrics/Biostatistics
  • Business Technology/Applications/Solutions
  • Business Analyst
  • CTO
  • Project Management

Medical and Scientific Professionals

  • Chief Medical Officer
  • Chief Science Officer
  • Compliance
  • Drug Safety/Pharmacovigilance
  • Quality Assurance
  • Regulatory Affairs

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Comprehend

Comprehend offers a suite of Clinical Intelligence applications that enables ClinOps Execs, Data Managers and Medical Monitors to significantly improve the speed, safety and quality of a portfolio of clinical trials. Across studies, sites, systems and CROs, Comprehend’s Clinical Intelligence Suite is particularly effective for centralized monitoring, risk monitoring, CRO oversight and collaboration, and medical monitoring initiatives. Comprehend gives life sciences companies a new source of competitiveness and the confidence to deliver high quality trial submissions at a new speed. Comprehend: the speed to quality results.

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