• AstraZeneca’s Pragmatic Approach To Clinical Research

    Clinical Research News | AstraZeneca has been embracing the use of real-world evidence (RWE) for clinical research to help overcome some of the new and perennial challenges in moving medicines to market. The company has been actively using RWE to optimize study protocols, assess new opportunities, employ external arms/comparators, enable pragmatic clinical trials, and transform endpoints, she reports.

    Mar 22, 2021

  • CVS Health, Salesforce Enlarging Their Roles In Clinical Research

    Clinical Research News | Hyper-local engagement and hyper-customized communications are both are necessary as the industry continues its shift toward decentralized clinical trial strategies, and the needs have prompted the entry of non-pharma companies into the clinical research space, including CVS Health and Salesforce, according to a keynote presentation at the recent Summit for Clinical Ops Executives (SCOPE).

    Mar 19, 2021

  • Reengineering Trials Is An Organizational Imperative

    Clinical Research News | In the space of a year, the clinical trials enterprise has made “a decade of progress” in the way it conducts studies, according to Harlan Krumholz, cofounder of Hugo Health, who spoke about participant-partnered research at the recent Summit for Clinical Ops Executives (SCOPE).

    Mar 18, 2021

  • How Active Safety Analytics Can Help Pharma Companies Increase Public Confidence in COVID-19 Vaccines

    Clinical Research News | The biggest US vaccine initiative is currently underway, with 32.3 million people having received at least one dose of either Pfizer-BioNTech or Moderna’s COVID-19 vaccine—including 37 million who have been fully vaccinated—as of the second week of March.

    Mar 17, 2021

  • Award-Winning Participant Engagement Strategies

    Clinical Research News | A lot of technology companies talk about the importance of patient input on the products they build, but Medidata is the first to hire patient advocates to provide feedback throughout the development life cycle—specifically, the patient cloud products it deploys in clinical trials, says Alicia Staley, senior director of patient engagement. “We’ve put a process in place to hold our own feet to the fire,” she says. “If our patient advocates haven’t looked at something rolling out the door, an explanation is expected as to why not.”

    Mar 16, 2021

  • How To Integrate The Patient Voice Into Trial Design

    Clinical Research News | The need to listen to the voice of patients at the right time, in the right context, and in their own language was a dominant theme of a live panel session at the recent Summit for Clinical Ops Executives (SCOPE) where views were shared on integrating patient insights into clinical trial design.

    Mar 15, 2021

  • Clinical Control Tower Providing Near-Real-Time View Of GSK Trials

    Clinical Research News | Thanks to COVID-19, asset leads at GlaxoSmithKline (GSK) can now tap a Clinical Control Tower for answers to five critical questions about how studies are progressing and if they are veering off course. The platform was developed last year to enable trial leaders to maintain business continuity during the pandemic.

    Mar 12, 2021

  • Antibodies Plus Vaccines, RWD on Post-Shot Reactions: COVID-19 Updates

    Clinical Research News | Top COVID-19 news and research stories of the week: real-world data from Mass General Brigham staff after vaccination, antibodies and the jab, and springtime impacts on infection rates.

    Mar 12, 2021

  • SCOPE 2021 Highlights New Value Props From Vendors

    Clinical Research News | New products, acquisitions, and a Cannes Film Festival award—some of the noteworthy announcements heard on the virtual exhibit hall floor during SCOPE 2021.

    Mar 11, 2021

  • Janssen Lost Little Ground on Trials Due To COVID-19

    Clinical Research News | Many of the process-related changes Janssen made in response to COVID-19—including virtual investigator meetings, analytic risk-based monitoring (ARBM), and direct-to-participant clinical trial approaches—will endure beyond the pandemic.

    Mar 10, 2021

  • Solving Real Problems from the Depths of the Technology Echo Chamber

    Clinical Research News | Much is said about how technology can transform healthcare with countless technologies being explored and used like machine learning, IoT, wearables, biosensors, natural-language processing, and digital therapeutics. But before we chase the latest and greatest technology, we must ask the critical question: “What problem are we trying to solve?”

    Mar 9, 2021

  • How Pfizer’s ‘Science Will Win’ Mantra Played Out Behind The Scenes

    Clinical Research News | One year after COVID-19 was declared a pandemic by the World Health Organization, a handful of Pfizer clinical operations leaders talked openly about the “one-team mindset” that helped usher a safe and highly efficacious vaccine to market in record time.

    Mar 8, 2021

  • Data-as-a-Service for Trials, Real World Data, Genomics Data For Cancer Trials: News and Products for February

    Clinical Research News | Wearables for blood cancer clinical trials, new members of DTRA, new light and health research center, digital twin consortium, and more.

    Mar 8, 2021

  • Oral Disorders Linked to SARS-CoV-2, Statin Use Increases Survival Rate, Abnormal Sodium Levels Predict Death Risk: COVID-19 Updates

    Clinical Research News I Repurposed arthritis drug falls short in Phase 3 clinical trial, optimal timing for donating convalescent plasma is within 60 days of symptom onset, most pregnant women and mothers report that they will vaccinate themselves and children, and only small percentage of COVID-19 patients suffer stroke, risk increases with age and CV risk factors. Plus: Clinicians warn of delayed injection-site reaction to Moderna vaccine for proper management and swollen salivary glands may be a common COVID-19 side effect.

    Mar 5, 2021

  • SCOPE 2021: New Players in Clinical Trials, AstraZeneca on RWE, Transcelerate Updates

    Clinical Research News | Day two of the Summit for Clinical Ops Executives (SCOPE) brings more updates from big pharma on the impacts of the COVID-19 pandemic, how AstraZeneca in deploying real-world evidence (RWE) in trials across broad therapeutic areas, and more.

    Mar 4, 2021

  • Medidata Named Winner of 2021 Participant Engagement Award

    Clinical Research News | Live at SCOPE yesterday, the winner of the 2021 Participant Engagement Award was chosen by a panel of judges. Patient Centricity by Design, a project from Medidata, was named the grand prize winner.

    Mar 3, 2021

  • SCOPE 2021: Pfizer, GSK’s Approach to COVID-19 Research, Patient Voice In Trials

    Clinical Research News | At the kickoff day for the Summit for Clinical Ops Executives 2021, teams from Pfizer talk vaccine development, Bayer, Pfizer, Abbvie and GSK report on the role of the patient in trial development, and GSK discusses the need for a “single source of truth” in pandemic response.

    Mar 3, 2021

  • Pandemic Highlights Value Of Remote Clinical Trials, Drug Repurposing

    Clinical Research News | A keynote address earlier this morning during opening ceremonies of the 2021 Summit for Clinical Ops Executives (SCOPE) offers glimmers of hope that the notoriously rigid clinical trial process may retain at least a few of the warp-speed changes introduced by the COVID-19 pandemic.

    Mar 2, 2021

  • Intranasal Vaccines, Vax Data for RWD Exploration, Down Syndrome Impacts: COVID-19 Updates

    Clinical Research News | A survey of how rehabilitation is helping patients with severe COVID-19, what COVID-19 means for Down Syndrome patients, and the timing of vaccines. Plus: real world data for COVID-19 vaccination, intranasal COVID-19 vaccine, more.

    Feb 26, 2021

  • It Took A Village To Speed Pfizer COVID-19 Vaccine Into Arms

    Clinical Research News | Deployment of clinical trials for Pfizer’s COVID-19 vaccine candidate was the fastest in the company’s history, and possibly industry-wide. Six weeks after the decision was made to run the combined phase 1/2/3 study, the first patient was enrolled and, six months later, it had all the safety and efficacy data needed to request Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to start getting the vaccine into people’s arms.

    Feb 25, 2021