Jonathan manages data and study operations at BIOC, which includes data mgmt, SAS, study design, programming and quality control. He has a MS in QA/RA and a BA from Temple and he is a certified quality auditor (CQA) and certified clinical data manager (CCDM). Jonathan is also Past Chair of SCDM.
PRESENTER
(S):
Joseph Dustin, Medidata Solutions Worldwide, United States
Founder QA Edge 1995. Specialty is computer validation. Has 20+ years CV exp. & has trained thousands on CV/Part 11. Has conducted over 80 audits. Has MS in Tech Mgmt (Penn) and BS in Commerce and Engineering (Drexel). Certifications in R/A, ISO 9000 Lead Assessor, Intl Bus. & IS Project Mgmt.
Since 2002, I have been immersed in the world of eClinical. I came in as the new guy, with new ideas, and new perspectives in an industry that still needs help when using technology to facilitate clinical research. Past companies include Medidata, CRF Health, and etrials. about.me/joedustin
Description
This showcase will aim to address the intricacies of navigating an ever changing eClinical world. Presentations will be shared from a technology, regulatory and standards perspective with an emphasis on how it all fits together. With recently issued draft guidance, clinical research professionals are being encouraged to be more electronic in their approach to clinical trials and to use more remote and central monitoring for clinical trials. The end of the research silo era is near! Developed by the eClinical (EC) SIAC.
Learning Objectives: Discuss the latest draft guidance's and how they relate to clinical trials Define best practices for complying with new expectations Identify new collaboration documents to help achieve cross functional working relationships.