EDC Today and Tomorrow

Sponsored by
Bioclinica

3 part webinar
60-minute presentation followed by 30-minute Q&A

Presenters

Jonathan Andrus, CCDM, Vice President, Data and Study Operations, manages data and study operations for BioClinica, Inc. In this role he is responsible for overseeing the design, development, implementation and management of all clinical studies. This includes forms design, standards and standards management, edit check programming, clinical data review and medical coding.

Prior to joining PDS, Mr. Andrus managed clinical system validations and Part 11 & HIPAA assessments, and conducted computer system audits with Taratec Development Corporation. He also served in a number of different data management and business process management roles at Premier Research, a contract research organization located in Philadelphia, PA.

Mr. Andrus has a Masters of Science in Quality Assurance and Regulatory Affairs from Temple University ’s Graduate School of Pharmacy, a Bachelor of Arts from Temple University ’s College of Arts and Sciences, and he is a certified quality auditor (CQA) and certified clinical data manager (CCDM). His professional affiliations include the Drug Information Association (DIA), the Society for Clinical Data Management (SCDM) (where he serves on its board of trustees and is currently the immediate past chair), the American Society for Quality (ASQ) and the EHR Value Case Working Group. Mr. Andrus is a frequent speaker on topics related to electronic data capture, quality assurance and regulatory topics.

Dawn Kaminski – has been the in the pharmaceutical industry for more than 12 years. During that time, Dawn has held several positions including Project Manager and Director of Data Management. She has managed or had oversight on more than 250 clinical trials using a variety of Data Management systems including fax based, paper, and EDC.
Dawn is currently the Product Manger of EDC at Octagon Research Solutions and is responsible for the vision and development of ViewPoint FUSE, Octagon's EDC solution.

Dan Crawford – has been in the pharmaceutical industry for 20 years. Dan spent fifteen years in Data Management where he managed or had oversight on more than 250 clinical trials. Dan is currently the Director of Clinical Data Strategies at Octagon Research Solutions where he provides training and consulting on the implementation of data standards and submissions to FDA. He is also responsible for the vision and development of ViewPoint FUSE, Octagon's EDC solution.

Overview

This webinar will provide the participant with information they need to know to successfully start up, maintain and closeout an EDC study. In addition, it will provide information related to the trends and future direction of EDC and the eClinical space, with a focus on standards and other complementary data sources, such as electronic health records and how they will influence the EDC environment.

Outcomes

Part I

  • Describe best practices and make recommendations for how to have a successful start to EDC Studies
  • Identify the CDM deliverables during start up
  • Use effective tools/checklists to evaluate the capabilities of vendors/suppliers to support deployment.

Part II

  • Describe best practices and make recommendations for how to successfully manage the study during conduct stage.
  • Identify best practices in managing change: Core Software; Study Specific
  • Identify best practices related to reviewing, cleaning and remedying data in an EDC environment.

Part III

  • Describe best practices and make recommendations for how to successfully manage the study during the closeout phase of the project.
  • Identify the various statuses necessary to ensure that an EDC database is ready for soft and hard lock
  • Describe areas to examine during an audit of an EDC study database.
  • List the types and content of deliverables to be created at study closeout
  • Know the current standards and where they are going in the future (CDASH, SDTM)
  • Describe the external data sources that surround EDC and what impact they may have in the future (EHR).
  • Describe initiatives and projects that are going on which may impact the way that data are collected in the future (CTTI, EHR Value Case Project)

Level

Intermediate to Advanced

Target Audience

CEOs, chief learning officers and trainers, clinical data managers, managers of data groups, quality control and quality assurance statisticians, biostatisticians, and project managers working within the clinical trials industry.

Continuing Education Credit Opportunity

Attendees are eligible for CEUs upon attendance and successful completion of assessment questions.  Each part of this 3 part webinar carries 0.2 CEUs.
SCDM is authorized by IACET to offer .2 CEUs for this program.

 

Purchase