GUEST CONTRIBUTORS

  • ClinicalTrials.gov: To Get Better Results, Talk To The Real Audience
    ClinicalTrials.gov: To Get Better Results, Talk To The Real Audience

    While controversy continues to simmer over who is accountable for posting results on ClinicalTrials.gov, perhaps the “results debate” masks the more challenging problem: ClinicalTrials.gov is not working for its intended audience.

  • Why All The Hype Around Real-World Evidence? Here’s What You Need To Know
    Why All The Hype Around Real-World Evidence? Here’s What You Need To Know

    This is part 2 of a two-part roundtable Q&A on real-world evidence (RWE) in the 21st century. In this installment, our experts discuss how RWE is utilized, why real-world data (RWD) analyses are getting more attention, and what the recent attention means for the future of medical practice and drug development. RWD analyses are utilized to generate insights about a medicine’s effectiveness, safety, and associated costs.

  • R&D Data Sharing: Where We Are & Where We Need To Go
    R&D Data Sharing: Where We Are & Where We Need To Go

    The clinical research industry has been slow to efficiently use and repurpose data collected in clinical trials. The lack of ease, both from an ethos and technical perspective, with which pharmaceutical companies can access and share data can lead to lengthier product development, untapped study findings, and reduced collaboration between industry stakeholders. As trials become increasingly complex and costly, it is especially important to develop approaches that facilitate and encourage R&D data sharing. This not only helps clinical trial sponsors to create better informed clinical development plans and run smaller, more efficient trials, but allows patients to enroll in trials sooner and, therefore, bring innovative new therapies to the market faster.

More From Guest Contributors

CLINICAL TRIAL WHITE PAPERS

  • The Convergence Of GDPR, The HIPAA Security Rule, And Part 11 On US Clinical Research
    The Convergence Of GDPR, The HIPAA Security Rule, And Part 11 On US Clinical Research

    As electronic research systems are increasingly relied upon to store participant data, report results, and confirm informed consent, regulatory bodies around the world are re-examining old regulations and developing new ones. Discover what it means for US research.

  • Considerations For Using eTools In Research: Part 11 And System Validation
    Considerations For Using eTools In Research: Part 11 And System Validation

    Automation is a foregone conclusion, and research sites need to prepare themselves for the electronic future that lies ahead.

  • Trial Resullts Summaries: Improving Patient Communications
    Trial Resullts Summaries: Improving Patient Communications

    This paper discusses the challenges inherent in the current practices of providing trial results summaries to trial participants. It presents an alternative approach to distributing trial results summaries that takes advantage of commonly used technologies to more quickly, efficiently and reliably provide trial results summaries to trial participants. The benefits of this approach to clinical trial sponsors, patients, and their relationship with each other are also discussed.

  • Tracking And Managing Global Disclosure Performance
    Tracking And Managing Global Disclosure Performance

    The following paper discusses the challenges of tracking global disclosure performance and how clinical trial sponsors can use Atlas Global Compliance to manage track and reduce the risks of non‐compliance.

More Clinical Trial White Papers

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Welcome to Clinical Leader, the premier online community that helps streamline clinical research by connecting trial sponsors and cutting edge service providers. Clinical Leader is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.

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