It’s official. Decentralized clinical trials have disrupted the clinical trial process for good. The COVID-19 pandemic elevated many digital innovations, proving that virtually connecting with patients is not only convenient but necessary when it comes to providing equitable access to cutting-edge treatments and clinical research.
Historically, traditional clinical trials have always experienced recruitment and retention challenges due to inconveniently located trial sites, lack of awareness
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Life Sciences | News, Analysis, Insights - HIT Consultant
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
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
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
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
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
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
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
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
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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