FEATURED ARTICLES

• eConsent Readiness In 24 Countries

  Discover how regulatory bodies worldwide, including the U.S. Food and Drug Administration and the European Medicines Agency, are now championing the shift towards eConsent adoption.

• The Place Of PROs In The Future Of Healthcare

  Discover how integrating Patient-Reported Outcomes can drive alignment with Value-Based Care (VBC) principles, enhancing product marketability and adoption while promoting patient health and quality of life.

• Accelerating AI Innovation In Pharma: Collaboration Vs. Competition

  Learn how evolving with AI could potentially lead to more streamlined, efficient, and innovative drug development processes.

• What FDA, EMA Discussion Papers Reveal About AI In Clinical Research

  Learn how having a comprehensive understanding of regulatory perspectives on AI ethics will prove invaluable for researchers evaluating the integration of AI technology into their trials.

• 10 FAQs On eConsent

  Closely examine the challenges of adoption, integration, and compliance measures involving eConsent and gain valuable insights for those contemplating their incorporation in clinical trials.

• Preparing For Post-Market Clinical Follow-Up Under EU MDR

  Gain a better understanding of the primary challenges faced by the life sciences industry's commercial model in response to the updated EU MDR guidelines.

• Impact Of Direct Data Capture On Clinical Trial Timelines

  Explore a broader strategy for shortening clinical trial timelines that encompasses various elements, ranging from enhancing interoperability to implementing AI-driven technologies.

• Essity Uses eConsent To Optimize Enrollment

  See how a global hygiene and health company was able to deploy virtual methods through a strategic partnership to recruit and retain participants, streamline consent, and analyze patient data.

• Biomarkers And Digital Endpoints For Modern Trials

  Explore how biomarkers and digital endpoints address inefficiencies, significantly accelerating the pace of clinical trial processes, and have the potential to revolutionize medical research.

• How Electronic Source Data Revolutionizes Clinical Research

  By increasing interoperability and embracing digital solutions, see how the research community can maximize the benefits offered by eSource, leading to improved trial outcomes and data quality.

• The State Of Design And Evidence Generation In Rare Disease Trials

  Discover how innovative trial designs, the utilization of RWD and RWE, and the development of synthetic control arms are poised to drive advancements in the field of rare diseases.

• How Master Protocols Are Accommodating Trial Advances

  As a result of trial design changes in the life sciences industry, learn what drug developers are doing to keep pace with the ongoing advancements in genomics, immunology, and precision medicine.

• Preparing Studies With eConsent For IRB Approval

  Understand how eConsent can benefit trials and align with IRB ethical commitments, how to prepare your IRB submission for approval, and the future impact of large language models.

• Unlocking The Power Of Real-World Evidence In FDA Submissions

  Understand the gaps between how data is collected in real-world evidence (RWE) and randomized clinical trials (RCT) and how RWE is quickly finding ways to catch up.

• How M2M Will Accelerate Clinical Research

  Discover ways that leveraged machine-to-machine devices connected directly to the Internet of Things could benefit clinical trials.

• 3 Things To Know When Using Wearables In Your Study

  As wearables unleash new possibilities, the industry will need an effective strategy to utilize these useful tools. Consider these tips when incorporating wearables in a clinical study.

• The EU MDR Is In Effect. Now What?

  In May 2021, the EU MDR replaced the EU's Medical Device Directive and Directive on Active Implantable Medical Devices. Learn about the basics of this regulation, who it impacts, and how to collect EU MDR-compliant clinical data.

• How EDCs Are Changing The Game In Clinical Research

  Explore all things EDC in this article: what it is, how researchers can use it in clinical trials, its numerous benefits, and examples of how these translate into the real world.

• Automated Data Capture To Train An AI Algorithm With eSource

  Explore why an AI algorithm needs a steady and significant stream of data to become more accurate and prove its efficacy in a clinical setting.

• Five Steps To Improve Patient Engagement And Drive Better Outcomes In Clinical Trials

  In order to have a successful clinical trial, researchers must recruit—and retain—patients. This is a struggle that researchers know well: only 1 in 20 patients who respond to a recruitment promotion complete the study, with only 1 in 5 showing up for initial screening.