Data Management

Understanding the benefits and concerns associated with implementing datasets into clinical trial workflows.

COVID-19 not only advanced scientific boundaries, but also transformed research methodologies and accelerated adaptive clinical trial design.

Addressing data integrity and compliance concerns.

In this video interview, Yael Elish, founder, CEO, StuffThatWorks; and Julie Ross, president, CEO, Advanced Clinical, discuss how newly emerging data from patients can help the industry improve its recruitment strategies.

This year’s conference highlighted a number of critical areas in clinical R&D including financial management, representation, and eCOA.

Teams must work together with technology solutions and optimize integration to unlock their full potential.

Webinar Date/Time: Tuesday, April 1, 2025 at 11:00 AM EST

In this video interview, Dipanwita Das, CEO & co-founder, Sorcero; Sujay Jadhav, CEO, Verana Health; and Kimberly Tableman, founder & CEO, ESPERO, highlight areas around clinical data that could have a large impact on the industry in 2025.

Webinar Date/Time: Thu, Mar 13, 2025 11:00 AM EDT

The ongoing evolution of real-world evidence from a novel concept to a cornerstone of modern medical research signifies its growing importance and vast potential to improve personalized medicine, overall healthcare outcomes, and eventually democratization of scientific facts by general accessibility.

In an interview with ACT senior editor Andy Studna at SCOPE Summit, Drew Garty, chief technology officer, clinical data, Veeva Systems, discusses clinical data trends for 2025 and simplifying management processes.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Shakthi Kumar, chief strategy & business officer, Edetek, discusses how Edetek's R&D cloud system addresses challenges in clinical data management.

Examining those technology-supported areas that sponsors, CROs, and sites consider the most valuable.

Leveraging and benchmarking insights to boost efficiency and optimization.

Insights identify opportunities to optimize sponsor, CRO, and site collaborations.

The conundrum of missing data vs. inter-rater variability.

Phase III CheckMate -8HW trial shows the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) significantly improved progression-free survival and overall response rates in patients with microsatellite-instability–high or mismatch-repair–deficient metastatic colorectal cancer.

In this video interview, Dipanwita Das, CEO & co-founder at Sorcero, highlights increased data management, DE&I, and regulatory preparedness as key trends for the industry in 2025.

Use of decentralized approach in a Phase 1 pharmacokinetic trial shows the ability to enable remote data collection and monitoring, which could improve patient access and enhance the efficiency of clinical research.

In this video interview, Kimberly Tableman, founder & CEO, ESPERO, discusses how EDC and EHR data can be streamlined to increase efficiency at sites.

In this video interview, Kimberly Tableman, founder & CEO, ESPERO, highlights how data standards are empowering the use of artificial intelligence.

An updated long-term analysis of the Phase III KATHERINE trial confirms that adjuvant treatment with Kadcyla (trastuzumab emtansine) significantly improves overall survival and long-term invasive disease–free survival compared to trastuzumab monotherapy in patients with HER2-positive early breast cancer with residual invasive disease.

In this video interview, Kimberly Tableman, founder & CEO, ESPERO, talks protocol submission formats and how data interoperability can support artificial intelligence.

A focus on data and process excellence advances product development.

Pilot trial shows that a user-friendly electronic patient-reported outcome (ePRO) monitoring system significantly improves patient-centered cardiovascular care by enhancing patient-physician communication, increasing clarity in treatment explanations, and empowering patients with better knowledge of their conditions.