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Welcome to the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & Compliance. Update your topic preferences to receive additional Clinical Leader newsletters on:
- Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
- Clinical Trial Technology (Tuesday)
- Decentralized Trials | Trial Management (Wednesday)
- Clinical Data Management & Analytics | Trial Monitoring (Friday)
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Walmart’s Healthcare Research Institute Is Ready To Aid Underserved Communities
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From The Editor |
By Ed Miseta, chief editor, Clinical Leader
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On October 10, 2022, Walmart announced its Healthcare Research Institute (WHRI), with the mission to improve care for underserved communities. WHRI offers the opportunity for patients in rural and underserved communities to participate in clinical research.
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How CROs Can Simplify Billing
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Article |
Sikich
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Explore how embracing a robust, modern industry-specific ERP solution can help streamline workflows, reduce errors, improve visibility, and enhance your customer’s billing experience.
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12 Ways To Avoid Delays In Hemato-Oncology Trials
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Article |
Cmed Clinical Research Services
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The COVID-19 pandemic has exacerbated the usual factors that can impact the start of clinical trials, including the need for the right study design, patient recruitment, appropriate inclusion/exclusion criteria, commercial/risk concerns, and compliance with international regulatory constraints.
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Patient Over Process: The inSeption Group Difference
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Video |
inSeption Group
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Everything we do is driven to challenge the status quo in the current outsourcing paradigm. inSeption is a home for clients and professionals who have been stifled by mainstream, high-volume, commoditized outsourcing models.
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FDA Releases Final Guidance On RWD/RWE Submissions For Drugs And Biologics
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Guest Column |
By Sean Hilscher, vice president, Greenleaf Health
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The guidance describes the approach sponsors should use to identify if and how real-world data (RWD) and real-world evidence (RWE) are incorporated into their regulatory submissions. The FDA notes that this guidance specifically applies to INDs, NDAs, and BLAs that contain RWD and RWE.
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Asia Pacific As A Clinical Trials Powerhouse
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White Paper |
By Dr. Annie Siu, Ph.D., MBA, Citeline, and Andy Benson, MSc, Trialtrove
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During the period from 2012 - 2021, APAC became a hotspot for clinical trials, with trial activity trending upward and eventually contributing almost half of the entire global clinical trial activity in 2021. Explore the driving forces and unique differentiators among each location within this region.
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The Composition And Value Of A Portfolio Analysis
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Brochure |
Premier Consulting
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One of Premier Consulting’s differentiating offerings is the portfolio analysis: a high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability of each product within a sponsor’s portfolio.
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