Topic

Articles

Growing availability of RWD leads new drug development process.

Using Real-World Data in Patient Recruitment

Push for accurate data collection during pandemic led by increased focus on patient engagement.

ePRO and Ensuring Data Integrity

In this interview, Heather Kopetskie, Director of Biostatistics for Rho, discusses some points related to proactively managing the many “e”s in data collection. 

Plan the Flow of Data Early for Maximum Effect

2020 Tufts CSDD – IBM Watson Health benchmarking study highlights need for new functionality from EDC solutions and providers.

Characterizing Clinical Data Management Challenges and Their Impact

To have a successful integration of data from across clinical systems, a strong understanding of the data is a critical.

The Value of Integrated Data Views for Clinical Trials

Benefits of business 4.0 approach in EDC in med-dev studies.

Adopting a Technology-Driven Approach to Implementing EDC for Medical Devices

Spotlight on clinical trials created by COVID-19 pandemic has forced regulatory officials around the world to expand disclosure requirements on results.

Top 5 Global Clinical Trial Disclosure Changes in 2020 Amidst Pandemic

Michael Weis, SM, is principal of Michael B. Weis Consultancy, P.O. Box 414, Ringoes, NJ 08551, (609) 466-1261, fax (609) 466-9353, email: michaelbweis@aol.com.

Irv Cantor, EdD,* is associate director, technology and quality control, with Johnson and Johnson Pharmaceutical Research and Development, 920 Route 202, Raritan, NJ 08869, (908) 704-4993, email: icantor@prdus.jnj.com.

Mary Jean Link, MS, MBA, is manager of IM quality and compliance for J&JPRD, Raritan, NJ, (908) 704-4370, email: mlink@prdus.jnj.com.

The right person can successfully promote proper management of quality and compliance, leading to desired clinical trial outcomes.

The Quality Coach

Flexibility to work on assignments whenever one's schedule permits can be the only realistic way to pursue further education.

Going The Distance

Think about how you wish to use ODM across an organization, not just within a single trial. All that needs to happen is for the same identifier to be used to denote two different studies and the data for both appear to come from the same study!