Risk-based Monitoring: Using Centralized Data Surveillance to Evolve Data Review and Site Engagement

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Pharmaceutical, Drug Safety,
  • Thursday, March 20, 2014

Holistic clinical trial insights are improving efficiency in clinical development through timely, integrated data. Armed with critical, actionable insights, medics, clinical project managers, research associates and investigators can identify and take action on potential issues faster than previously possible – but changes are required in how we integrate processes across these roles.

Technology is enabling the evolution of risk-based monitoring by integrating study start-up, clinical monitoring, project management, data management and analytics to optimize and improve clinical trial execution by leveraging risk assessment, ongoing data surveillance, and dynamic monitoring, providing:

  • Integrated data for holistic trial insights
  • Improved data quality and patient safety
  • Identification and mitigation of risks
  • Lower costs for more development opportunities

Register today to listen to industry experts highlight key learnings and changes to how clinical development is being performed. By attending this webinar, you will:

  • Understand changing roles and processes with data management, project management, site management, data review, medical review
  • Learn how technology is enabling shifts in executing clinical trials
  • Gain insights into how Investigator Sites are benefitting from these changes

Speaking from years of experience, Martin Giblin and Teresa Lamantia will share insights they have gained through years of deploying risk-based monitoring principals and procedures from a variety of therapeutic studies on a global scale.

Speakers

Martin Giblin, Vice President, Clinical Data Management, QuintilesTeresa Lamantia, Vice President, Strategic Operations, Quintiles

Martin began his career in the IT industry before moving to management consultancy for 10 years. He has worked across multiple industries including financial services, utilities, manufacturing, media and healthcare. Having worked at Quintiles 10 years in data management, technology and clinical operations, his particular interest is in the application of technology to the trial execution process. He currently heads Quintiles CDOS (Centralised Data and Operational Surveillance) group, a core component of Quintiles RBM offering. Martin has a BA and BAI in Engineering from Trinity College in Dublin and an MBA from UCD, Dublin.

Teresa Lamantia, Vice President, Strategic Operations, Quintiles
Teresa is responsible for setting the global strategy for clinical services and for driving operational improvement and innovative business model development at Quintiles. She is the global lead for Quintiles Risk-based Monitoring Strategy and has provided numerous consultations to customers and helped lead the build of RBM strategies for several key accounts. Prior to this role she was the head of North America and Latin America Global Functional Resourcing. She joined Quintiles in 2002 and earned a BSN from Vanderbilt University and an MSN from the University of Cincinnati.

Message Presenter

Teresa Lamantia, Vice President, Strategic Operations, Quintiles

Teresa is responsible for setting the global strategy for clinical services and for driving operational improvement and innovative business model development at Quintiles. She is the global lead for Quintiles Risk-based Monitoring Strategy and has provided numerous consultations to customers and helped lead the build of RBM strategies for several key accounts. Prior to this role she was the head of North America and Latin America Global Functional Resourcing. She joined Quintiles in 2002 and earned a BSN from Vanderbilt University and an MSN from the University of Cincinnati.

Message Presenter

Who Should Attend?

EVPs, VPs, Directors, Heads, Managers, Principal Scientists of:

  • Clinical R&D
  • Clinical Operations (Clinical Project Leads, Clinical Program Managers, Therapeutic Heads, Clinical Data Managers, Pharmacovigilance Scientist)
  • Regulatory Affairs
  • Medical Affairs
  • Outsourcing Management

Xtalks Partner

Quintiles

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, and consulting solutions worldwide. The Quintiles network of more than 27,000 engaged professionals in 59 countries works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visit www.quintiles.com.

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