Risk Based Monitoring in Clinical Trials

Thursday, 26th June 2014 - Frankfurt, InterCity Hotel Frankfurt Airport

Download the brochure of the event

Risk Based Monitoring in Clinical Trials

A new approach for managing risk-bearing activities throughout the design, conduct, evaluation and reporting of clinical trials.

Conduction of the 100% of Source Data Verification (SDV) at every investigational site or the implementation of the current common practices in trial monitoring are not the way to assure the quality of data in a clinical trial and are acknowledged to be time and costs consuming.

FDA and EMA issued guidelines suggesting an alternative way of monitoring a clinical trial and encouraging the use of electronic systems and strategies to identify and prevent risk factors for the quality of data, patient safety and trial integrity.

Several technology based solutions have been implemented for the data collection and integration of all clinical trial data and for the analysis and visualization of the risk based assessment. The ePharmaDay conference is dedicated to highlight the role of the technology to support the transition from the “common” to the Risk Based Monitoring by presenting:

• The importance of developing an overall risk assessment process

• The importance of providing the study team with better tools to have an holistic and dynamic oversight, focusing on the identified risk factors

• What will be the critical items the inspectors and Auditors will consider to guarantee the GCP compliance of Sponsors, CROs and Investigators, as well.

The Scientific Board, Heike Schön, Managing Director, LUMIS International, and Simone Ahrens, Data Operations Asset Lead, Parexel International GmbH, will share best practices, results and experiences in this field.

Who should attend?

The conference is addressed to all the Clinical Research Professionals with a deep interest in the implementation of a Risk Based Monitoring approach, belonging to the following departments:

  • Clinical Research and Development
  • Quality Assurance
  • Pharmacovigilance
  • Clinical Operations
  • Statistics and Data Management
  • Information Technology

from Pharmaceutical and Biotechnology companies, Clinical Research Organizations, Academic Centres, Hospital Centres, and Clinical Technology companies.

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