Since clinical trial data vary on many parameters (participant demographics, study procedures, method of data collection, etc.), case report forms should be developed according to an accepted standard. The Clinical Data Acquisition Standards Harmonization (CDASH) outlines best practices for presenting data to maintain consistency and quality across different trial phases and therapeutic areas. The use of CDASH also provides significant cost and time saving benefits to organizations conducting clinical trials.

In this webinar, three experts in clinical data programming will elaborate on these benefits, complete with demonstrations of how to build and use a CDASH-compliant library. Among other things, participants will learn how new standards in data entry processes make it easier for stats programmers to analyze data.

Keywords:

Speakers

Claude Toney, Clinical Data Programmer, Atlantic Research Group

Claude Toney has been in clinical research for 19 years. Starting as an In-house CRA, Claude widened his scope and moved into both project management and data management. Most recently Claude has become focused on clinical data programming and validation activities. He’s always scanning the horizon for more efficient ways of working to support colleagues and customers.

Message Presenter

Emilea Norris, Biostatistician, Atlantic Research Group

Emilea Norris has over 14 years of experience leading clinical trial development. She offers an array of cross-functional abilities including project management, data management, biostatistics and programming, and medical writing. Knowing the needs of the team, Emilea works to find solutions for effective communication. She likes working with drug and device development, study integrations, data collection, and missing (erratic) data handling.

Message Presenter

Kevin Limlengco, Atlantic Research Group

Kevin Limlengco, Clinical Data Programmer, Atlantic Research Group

Kevin Limlengco started programming with java in college. This led to both courses and self-teaching in python. Once he began working in the clinical trial industry, his skills made programming both in and out of EDC seamless. Kevin’s goal to providing Bios what they need from an EDC database upfront is what gets him up every morning!

Message Presenter

Who Should Attend?

Organization types:

CROs
Early-phase pharma
Medical device
Diagnostics

Roles:

Data managers
Clinical trial site managers
ClinOps professionals

What You Will Learn

Participants will learn:

How a CDASH-compliant library of electronic case report forms (eCRFs) can accelerate database development and result in data management cost efficiencies
How developing a validated eCRF library in collaboration with biostatistics minimizes study transfer programming
How a standardized eCRF CDASH-compliant library enables automated Study Data Tabulation Model (SDTM) mapping to forms

Xtalks Partners

Medrio

Medrio is the leading provider of eClinical technology for early-phase pharma, device, and diagnostics clinical trials. Founded in 2005, the company’s cloud-based EDC, eSource, eConsent, and ePRO solutions deliver fast, flexible, and easy-to-use tools for the collection and management of clinical data and patient reported outcome responses. Study sponsors and contract research organizations have used Medrio extensively in clinical trials across a wide array of therapeutic areas, with notable success in oncology, infectious disease, and more. Medrio has extensive experience in all study phases and leads the market in early-phase trials. The company serves over 500 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations. For more information, please visit www.medrio.com.

Atlantic Research Group

Based in Charlottesville, VA the Atlantic Research Group (ARG) is one of the fastest growing and most successful full-service CROs dedicated to agile and emerging biopharmaceutical companies. ARG has helped research sponsors in clinical trials of patients at more than 5000 investigative sites worldwide.

With a repeat customer rate of over 90%, ARG has become the preferred provider for nearly a dozen small biotechnology organizations developing everything from orphan status immunology and oncology compounds to pivotal Phase III trials.

Since its founding in 2004, ARG has utilized an array of Software-as-a-Service (SaaS) solutions to efficiently execute its sponsors’ clinical trials.