Fifth Annual
Electronic Data in Clinical Trials:
Collecting and Leveraging Data to Optimize Clinical Trials
February 5-6, 2013 * Hyatt Regency Miami * Miami, FL
Part of: Summit for Clinical Trials Operations Executives (SCOPE)

Dear Colleague:

We are pleased to announce production of Cambridge Healthtech Institute’s Fifth Annual Electronic Data in Clinical Trials: Collecting and Leveraging Data to Optimize Clinical Trials being held on February 5-6, 2013 at the Hyatt Regency Miami in Miami, Florida.

This 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 2012.  Electronic Data in Clinical Trials will be followed by the Integrating and Leveraging Clinical Trial Operations Data; Patient Recruitment and Retention in Studies and Registries; Clinical Trial Forecasting, Budgeting, and Project Management; and Managing Post-Marketing Studies and Registries conferences.

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

If you are interested in presenting, please submit a speaking proposal for review. Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators and those from academic /hospital centers. Additionally, as per CHI policy, a select number of vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.

The deadline for submission is May 25, 2012.  Click here to submit a proposal.

Marina Filshtinsky, M.D.
Conference Producer
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5496
E: mfilshtinsky@healthtech.com