About

Risk Based Monitoring in Clinical Trials

Wednesday, 8th October 2014 - Copenhagen

Download the brochure of the event

Risk Based Monitoring in Clinical Trials

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

Performing 100% Source Data Verification (SDV) at every investigational site is acknowledged to be time consuming, costly and not the best way to ensure data quality in a clinical trial.

The FDA and EMA issued guidelines suggesting an alternative way to monitor a clinical trial. These regulatory agencies encourage 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 collection and integration of all clinical trial data as well as for the analysis and visualization of any risk based assessments.

The ePharma Day conference is dedicated to highlighting the role of technology in supporting the transition from “common” to 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 when analyzing GCP compliance of Sponsors, CROs and Investigators, as well.

The Chairman for this event will be Soeren Stroeh, CEO of aCROnordic Health Claim Services ApS, and he will share his best practices, results and experience in this field.

Who should attend?

This conference is intended for Clinical Research Professionals with a vested interest in the implementation of a Risk Based Monitoring approach, especially those in the following fields:

• Clinical Research and Development

• Quality Assurance

• Pharmacovigilance

• Clinical Operations

• Statistics and Data Management

• Information Technology

As well as from the following sectors: Pharmaceutical and Biotechnology companies, Clinical Research Organizations, Academic Centres, Hospital Centres, and Clinical Technology companies.

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