White Papers

  1. 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.

  2. 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.

  3. Trial Results 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.

  4. 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.

  5. Clinical Trial Transparency: The Technology Imperative

    This paper looks at clinical trial transparency and the driving forces behind it to better understand the role of technology in the execution of a solid clinical trial transparency policy.

  6. Mobile eTMF: Once A “Would-Be-Nice”. Now A “Must-Have”!

    The benefits of off­ering a mobile experience are simply too great to ignore.

  7. MHRA’s GCP Findings: It’s About Oversight

    Hone in on the critical findings around the TMF and recording/keeping of essential documents.

  8. A Build Vs. Buy Look At Study Activation

    How  a cloud-based SSU Solution with a SaaS-based platform manages the complexities of study activation.

  9. Getting to True Agile IRT: 5 Questions To Ask Your IRT Vendor

    While many vendors are claiming agile IRT capabilities, it is important to dig deeply and examine these claims – as well as a company’s proven ability to provide predictable, consistent delivery of project timelines and quality.

  10. Making eSource Work: Beyond The Hype

    <p>Implementing eSource can mean operating differently from the norm, with potentially an initial layer of complexity before things become simpler.</p>