5 Components of a Patient-Centric eCOA Strategy for Oncology Clinical Trials

5 Components of a Patient-Centric eCOA Strategy for Oncology Clinical Trials

Melissa Mooney, Director of eCOA Solutions Engineering at IQVIAIn the US alone, an estimated 1.9 million new cases of cancer were diagnosed in 2022, positioning oncology as a key subject of clinical research. Throughout oncology trial development, it is important that stakeholders acknowledge that only patients can fully understand the impact of treatment on their lives. Regulators are now looking beyond clinical indications such as tumor size and delayed disease progression. When evaluating the risks and benefits of treatment, they want to know whether the side effects are tolerable for patients and how these treatments could be improved from the patient’s…

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HIMSSCast: Epic leaders on data-driven clinical trial innovation

HIMSSCast: Epic leaders on data-driven clinical trial innovation

The challenges of designing effective clinical trials, finding the right people to participate in them and building trial cohorts that are representative of the population at large, have been well-documented.With its recent Life Sciences initiative, Epic has set its sights on data-driven insights to improve the development of new therapeutics and interventions. That includes improving all parts of the clinical trial process – from how physicians educate their patients about potential cohorts, matching and connecting patients with promising research and helping make sure those studies are optimally beneficial for as many people as possible. Epic is already helping its provider customers…

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Report: Pharma R&D ROI Falls to Lowest Level in 13 Years

Report: Pharma R&D ROI Falls to Lowest Level in 13 Years

What You Should Know:– Deloitte Centre for Health Solutions releases its thirteenth annual report, ‘Seize the Digital Momentum: Measuring the return from pharmaceutical innovation 2022’ that explores the performance of the biopharmaceutical industry (bio Pharma) and its ability to generate returns from investment in innovative new medicines.– Since 2021, much of the world has successfully adjusted to life where COVID-19 is more endemic as vaccines and treatments reduced the risk and severity of illness, however geopolitical turmoil and a global cost-of-living crisis have continued to drive serious instability in the health landscape.Pharmaceutical Innovation – Trends and Insights At a GlanceThis is…

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Hurdle, CloudLIMS Partner to Augment Diagnostic Lab Capabilities

Hurdle, CloudLIMS Partner to Augment Diagnostic Lab Capabilities

What You Should Know:– Hurdle (a Chronomics Inc. brand), a global bio-infrastructure platform that powers end-to-end diagnostics for life sciences, labs and healthcare providers, and CloudLIMS, a leading SOC 2 compliant and ISO 9001:2015 certified lab informatics provider, announced today that the companies have entered into a strategic partnership marking the first integration between a Diagnostic as a Service (DaaS) platform and a Software-as-a-Service (SaaS) LIMS provider.– The partnership brings together Hurdle’s remote diagnostic platform and CloudLIMS’s secure, purpose-built diagnostics LIMS to empower labs with the ability to offer at-home tests, and manage lab processes and data efficiently.Helping Diagnostic Labs Stay…

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Vendor Notebook: new tools and acquisitions from OptumRx, ScionHealth, others

Vendor Notebook: new tools and acquisitions from OptumRx, ScionHealth, others

It’s a new year, and healthcare technology vendors are rolling out their latest innovations, market approvals, acquisitions and staffing shake-ups.OptumRx launched Price Edge, a tool that compares pricing for traditional generic drugs to ensure members get the lowest prescription drug prices. A suite of new tools for both patients and providers target aspects of pharmacy logistics that have been known to delay or complicate care, such as getting real-time pharmacy benefits information and obtaining prior authorizations. In October, Optum, UnitedHealth Group’s pharmacy services company, merged with data clearinghouse Change Healthcare. The U.S. Department of Justice tried to block the merger and is appealing the…

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Episode 10: A Look at the  Proposed HIPAA Changes

Episode 10: A Look at the Proposed HIPAA Changes

In this episode of Health+Tech, Andrea Lee Linna and Jonathan Ishee are joined by fellow McGuireWoods digital health team member Michael Paluzzi to discuss proposed HIPAA changes that may require covered entities and business associates to overhaul their HIPAA policies and procedures in 2022.After providing a high-level overview of the proposed changes, the podcast turns to a live recording of Andrea and Jonathan’s recent webinar, “Preparing for Major HIPAA Changes in 2022,” offering in-depth details about the proposed changes and how to prepare for them in the new year….

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Episode 9: Digital Health Trends and Issues for Life Sciences Companies

Episode 9: Digital Health Trends and Issues for Life Sciences Companies

In this episode of Health+Tech, McGuireWoods healthcare attorneys Janice Suchyta, Kate Hardey, Kae Gruner and Royce DuBiner discuss the latest digital health updates from the Food and Drug Administration and Federal Trade Commission. Join the conversation as we wrap up Cybersecurity Awareness Month and discuss the following topics:• FDA draft guidance on electronic health records and medical claims data• FDA new resource for approved artificial intelligence/machine learning medical devices• FDA Digital Health Center of Excellence• FTC rules for health apps outside of HIPAA…

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Episode 8: Telehealth Barriers During Covid-19

Episode 8: Telehealth Barriers During Covid-19

In this episode of Health+Tech, McGuireWoods healthcare partner Janice Suchyta talks to Michele Satterlund, senior vice president in the state government relations practice of McGuireWoods Consulting and a partner with McGuireWoods, on the emergence of telehealth, particularly during the pandemic. They also look at how telehealth is evaluated state by state and discuss the need for uniform best practices….

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Episode 7: Houston Ready to Become the Third Coast for Biotechnology

Episode 7: Houston Ready to Become the Third Coast for Biotechnology

In this episode of Health+Tech, McGuireWoods healthcare partner Janice M. Suchyta talks to Donna Chang, founder and CEO of Hope Biosciences. Donna discusses how Texas — particularly Houston — is making a name for itself in biotechnology by attracting research funding, supporting premier academic medical centers and welcoming investment by major pharmaceutical companies. Hope Biosciences, a stem cell biotechnology company that has flourished as part of the biotech cluster in the Houston area, is helping to make Texas the third coast for biotechnology….

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Episode 6: Health Information Exchange and Security

Episode 6: Health Information Exchange and Security

In this episode of Health+Tech, McGuireWoods partners Jonathan Ishee and Andrea Lee Linna talk to George Gooch, CEO of the Texas Health Services Authority (THSA), about their cybersecurity, health information exchange and pandemic surveillance initiatives. They also discuss:Information blocking rule complianceRecent Texas legislation (now signed into law) affecting healthcare breach notificationThe role of health information exchange in public health surveillanceTHSA initiatives using open-source digital health tools to provide real-time situational awareness to healthcare providers during the pandemic…

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