Data Management

Martin Gouldstone, Global SVP, business development, Owkin, speaks to ACT on the use of AI in data practices and approaches for clinical research, and the distinction of “ethical AI."

Remote inspection and ICH guidelines among topics discussed at Veeva's most recent TMF Innovation Forum.

Presenting how data transformation is measured as part of the SAFE Data Standard, which data variables influence the rating and, how the appropriate level of data transformation is calculated.

Data is the heart of clinical trials, so life sciences firms need to integrate their technology to keep data sources and trial portfolios up-to-date and secure.

How management of trials must evolve.

Stakeholders from across the industry must discuss ownership to ensure effective implementation.

With an AI-enabled virtual assistant as part of your clinical research toolkit, deriving insights from clinical data is as simple as asking a question.

Improving receptivity and response to the evolving nature of clinical trial patient oversight.

Embracing patient empowerment in data collection can lead to new standard of care.

Cloud-based clinical metadata repositories can aid in accelerating clinops.

Advances in technology open door for improved EHR to EDC transfer process.

A discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.

Growing availability of RWD leads new drug development process.

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

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

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

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

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

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

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

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

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!

In the mid to late '80s, a tool called remote data entry was available which replaced double key data entry and paper case report forms (CRFs) at the clinical trial study site. When remote data entry (RDE) was used, the drug sponsor would provide a portable computer to the investigational site. The coordinator would collect study-related patient data, and then enter the data directly into the computer via the specially designed user interface of data entry screens. The electronic data would then be monitored. After data cleanup, a floppy disk with the site's data would be sent to the sponsor via an overnight courier service. These tasks would occur periodically during the course of the clinical trial.