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Life Sciences | News, Analysis, Insights - HIT Consultant

Decentralized Clinical Trials: Keys to Optimizing Diversity and Inclusion

by Michael Delisle, VP, Practice Leader for Digital Health at GattiHR 11/03/2021 Leave a Comment

Decentralized Clinical Trials: Keys to Optimizing Diversity and Inclusion

The U.S. pharma industry and research intuitions have long struggled with increasing clinical trial diversity in an effective, sustainable, and scalable fashion. Clinical research, in general, acknowledges the universal struggle of recruiting enough participants from various demographic groups. For example, racial and ethnic minorities have been historically underrepresented in clinical trials—a problem that still persists today. According to Deloitte, African Americans comprise 13% of the
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Medable Secures $304M at $2.1B Valuation for Decentralized Clinical Trials Platform

by Fred Pennic 10/26/2021 Leave a Comment

Medable Secures $304M at $2.1B Valuation for Decentralized Clinical Trials Platform

What You Should Know: - Decentralized Clinical Trials (DCT) leader Medable, today announced a $304M Series D funding round today – the company’s largest and fourth funding round in 18 months, bringing total capital raised to $521M – and valuation to $2B+. The funding round was co-led by new investors Blackstone Growth and Tiger Global and existing investor GSR Ventures. The round also includes follow-on investment from existing investors Sapphire
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Cerner Enviza Launches to Accelerate Therapies and Improve Patient Outcomes

by Jasmine Pennic 10/26/2021 Leave a Comment

Cerner Enviza Launches to Accelerate Therapies and Improve Patient Outcomes

What You Should Know: - Today, Cerner announced the launch of Cerner Enviza, a new operating unit that offers solutions to help bring clarity to multi-dimensional data through real-world evidence and insights. - Cerner Enviza℠ aims to accelerate the discovery, development and delivery of extraordinary insights and therapies to improve everyday health for all people globally. By combining decades of healthcare innovation, life sciences knowledge and collaborative research, Cerner
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FDA Selects Aetion Evidence Platform to Assess In-Patient COVID-19 Treatments

by Jasmine Pennic 10/21/2021 Leave a Comment

Syneos Health, Aetion Partner to Offer RWE Solutions to Advance Drug Development and Commercialization

What You Should Know: - Aetion, a NYC-based leading real-world evidence (RWE) company,  announced that the U.S. Food and Drug Administration (FDA) has contracted with them to use their Aetion Evidence Platform® to rapidly assess in-patient COVID-19 treatments and advance regulatory science to help determine when, where and how to use RWD. - This project is designed to demonstrate how using a platform-based approach
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3 Ways Decentralized Clinical Trials Can Expand Diversity & Improve Participation Rates

by Ryan Pack, Global Head Diversity in Clinical Trials, Science 37 10/20/2021 Leave a Comment

Ways Decentralized Clinical Trials Can Expand Diversity & Improve Participation Rates

I consider myself living proof of the American dream. In 1888, my great, great grandfather purchased a farm, Coleman Crest, that is still in our family today. Understanding his story and what he had to overcome during that period in history has given me such a great foundation and what still inspires me today.  My passion for chemistry began when I was a child. At a young age, I was diagnosed with a chronic illness and when things got tough, it was my pharmacist who gave me hope and
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3 Ways to Address Gender and Racial Bias in Clinical Trials

by Jennifer Jones-McMeans, PhD, Divisional Vice President of Global Clinical Affairs at Abbott’s Vascular Business 10/13/2021 Leave a Comment

Addressing Gender and Racial Bias in Clinical Trials, Racial Bias Clinical Trials, Gender and Racial Bias, Clinical Trials Racial Bias

I have dedicated my career to clinical research and making strides to advance modern medicine. In the work I do as a clinical researcher, we are addressing racial and gender biases that exist today in clinical trials. For example, in cardiovascular disease—my area of study—we know that women’s symptoms present differently than men and yet their symptoms have often gone undiagnosed or dismissed by physicians. It is well documented that communities of color have historically been mistreated by
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Lightship Raises $40M to Bring Decentralized Clinical Trials at Scale

by Jasmine Pennic 10/07/2021 Leave a Comment

Lightship Raises $40M to Bring Decentralized Clinical Trials at Scale

What You Should Know: - Lightship, a virtual-first provider of clinical trials, today announced that it has raised $40M to create access to clinical research for all patients and improving diversity among patient groups taking part in clinical trials around the world led by Define Ventures and Brook Byers, with participation from Khosla Ventures, McKesson Ventures and Marc Benioff’s TIME Ventures. This round of investment follows $20M of funding that Lightship announced in February 2020 to
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3 Ways Digital Health is Transforming Decentralized Clinical Trials

by Michael Delisle, VP, Practice Leader for Digital Health 09/29/2021 Leave a Comment

3 Ways Digital Health is Transforming Decentralized Clinical Trials

Decentralized Clinical Trials (DCTs) have been gaining steam over the last decade, but it was the COVID-19 pandemic that cast its advantages into the limelight. Sponsors benefit by creating efficiencies virtually throughout drug discovery, research, and treatment phases. However, the greatest long-term benefactors will ultimately be the patients.  Many aspects of traditional clinical trials are inconvenient for potential candidates, including the commute distance to trial sites, time
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RWE: Supporting Regulatory Submissions with Real-World Evidence

by Tiffany Siu Woodworth, Director, Analytic Solutions, Panalgo 09/15/2021 Leave a Comment

Supporting Regulatory Submissions with Real-World Evidence

In 2016, the 21st Century Cures Act was signed into law, mandating that the FDA “establish a program to evaluate the use of real-world evidence (RWE) to help support the approval of new indications for a drug and to help to support or satisfy post-approval study requirements.” Along with advances in the availability and quality of real-world data (RWD) from sources like electronic health records (EHRs), registries, medical claims and pharmacy data, the Cures Act has been a catalyst for increased
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Medidata, Labcorp Partner to Expand Decentralized Clinical Trials for Digital Biomarker Discovery

by Jasmine Pennic 09/13/2021 Leave a Comment

Medidata, Labcorp Partner to Expand Decentralized Clinical Trials for Digital Biomarker Discovery

What You Should Know: - Medidata, a Dassault Systèmes company, today announced a first-of-its-kind partnership with Labcorp using the Medidata Sensor Cloud to introduce a new model to advance the use of medical-grade sensors in clinical trials and accelerate biomarker discovery. - As part of the partnership, Medidata will receive and process medical-grade sensor data within drug, vaccine and device trials across Labcorp Drug Development’s clinical trial portfolio,
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