Electronic Data in Clinical Trials
Cambridge Healthech Institute (CHI) is pleased to announce the production of Electronic Data in Clinical Trials: Collecting and Leveraging Data to Optimize Clinical Trials being held February 7-8, 2012 at the Hilton Miami Downtown in Miami, FL.

The gathering will once again be co-located within the Summit for Clinical Trials Operations Executives (SCOPE), a three-day cluster of events that attracted 400 leaders in clinical operations and research in February 2011. CHI’s Fourth Annual Electronic Data in Clinical Trials will be preceded by a short course on EMR/EHRs: Utilization of Electronic Health Record (EHR) Data for Registration Studies and then followed by a new sister event, Integrating and Leveraging Clinical Trial Operations Data: Portals, Data Warehouses, Site/Study Execution Metrics. Please see the program map below for 2012. Topics to be discussed include:

  • Utilization of Electronic Health Record (EHR) data in clinical research: Overcoming regulatory, policy, technical and organizational challenges
  • Approaching data integration for BioTech, Small/Midsize Pharma and Big Pharma: Integrating systems (EDC, IVRS, CTMS) and clinical operations data
  • Increasing clinical trial efficiency through operational data management: Best practices in integrating safety reporting data and your EDC system
  • Incorporating and integrating the eClinical systems and practices of two organizations: Lessons learned in the latest set of mergers
  • Electronic Data Capture (EDC) adoption: Changes in processes and procedures and training staff (sponsor staff, site, CROs)
  • Available technologies and vendor selection: Selecting the right partner for your strategy
  • Regulatory compliance issues on the use of computerized systems in clinical investigations: Qualification of sites that have EMR/EHR systems for source documents; Regulatory audits at sites using EDC
  • Integration of mobile and web-based technologies to enable the patient-centered clinical trial
  • Leveraging technology to enable adaptive trials: Is EDC an absolute necessity?
  • E-Diaries: Ease of use and compliance in various populations and consistency of data with data previously collected by paper diaries
  • Information security and EDC: Safeguarding the security and reliability of Electronic Clinical Trials (ECT)
  • Practical implementation of CDASH recommendations