The FDA is requesting all clinical data in SDTM format for submissions today, and will mandate receiving data in this format within about two years. Therefore, while the production of SDTM datasets has historically been treated as a separate programming effort after study close, this effort can now appear right on the critical path to a timely submission. This means the old methods are no longer adequate.

In this free webinar, you will learn about the complexities and challenges in producing SDTM datasets from Albert Chau, Senior Director of Data Science at Sarah Cannon Research Institute (SCRI). Albert has 20+ years of experience in biostatistics & programming, and his department at SCRI is responsible for the development and programming of 50+ studies per year. SCRI is a prestigious research center handling some of the most complex oncology protocols in the industry, so Albert has deep experience in the real-world challenges of creating SDTM datasets using statistical programming.

In the second half of the webinar, Keith Howells of OmniComm Systems will present a groundbreaking new technology that allows SDTM datasets to be generated directly from an EDC system, such that initial datasets are available by First Patient In and final datasets are available within a few days of database lock. Keith is SVP of product development and previously worked for 18 years at Oracle Corporation, so he has a wealth of experience in data processing challenges. So if you don’t believe that an EDC product can contain the tools for data mapping, row transpositions, unions, calculated values and aggregate functions, please hold your skepticism until you’ve seen this webinar.

Keywords:

FDA
Clinical Data

Speakers

Keith Howells, SVP Development, OmniComm Systems, Inc.

Keith Howells is an executive with 20 years’ experience in the application of Information Technology to the drug development process. As Senior Vice President of Development at OmniComm, he is responsible for product innovation for the TrialMaster and eClinical suites.

Before OmniComm, Keith was Senior VP of Development at Medidata Solutions, responsible for the Rave product line. Prior to that, he played a major role in establishing Oracle’s Pharmaceutical application business, initially as director of consulting for Oracle Clinical and then as VP of Development.

Message Presenter

Albert Chau, CStat CSci, Senior Director, Data Science, SCRI Development Innovations

Albert Chau is a Chartered Statistician who has extensive experience in Pharmaceutical drug development across statistics, SAS programming, data management and data standards development.

He started out in large Pharmaceuticals: Rhone-Poulenc Rorer in France; Ciba; Glaxo-Wellcome and Novartis. In 2001, he set up his own consulting company providing statistics and data management consulting services to Pharmaceutical, biotech and medical devices organisations, as well as to other industries. In 2007, he joined Antisoma, a UK-based bioPharmaceutical company specialising in cancer therapy, as Head of Biometrics, where he set up the Biometrics department from scratch and implemented various CDISC standards in the company.

Currently Albert is the Senior Director of Data Science at SCRI Development Innovations, the CRO division of Sarah Cannon Research Institute (SCRI) with headquarter in Nashville, Tennessee. SCRI is a global strategic research organization focusing on advancing therapies for patients. It is one of the largest clinical research programs, conducting community-based clinical trials in oncology and cardiology through affiliations with a network of more than 700 physicians in the United States and United Kingdom. Albert’s Data Science group is responsible for all data management, statistics and programming activities for over 50 industry-sponsored trials and investigator-initiated trials in oncology each year. The group has been developing and implementing data standards, to cover data science activities from CRF development through SDTM and ADaM datasets to statistical outputs.

Message Presenter

Who Should Attend?

Clinical Program Managers
Lead Clinical Data Programmers
Heads of Business Technology
Heads of Regulatory Affairs
Heads of Data Management & BioStatistics (sometimes now referred to as Data Science or Biometrics)

Xtalks Partner

Omnicomm

OmniComm Systems is a leading strategic software solutions provider to the life sciences industry. OmniComm Systems is dedicated to helping the world’s Pharmaceutical, biotechnology, CROs, research and medical device organizations maximize the value of their clinical research investments. Through the use of innovative and progressive technologies these organization drive efficiency in clinical development, better manage their risks, ensure regulatory compliance and manage their clinical operations performance. OmniComm provides comprehensive eClincal solutions from Phase I through late phase clinical trials with an extensive experience with over 4,000 clinical trials.