Insights On Trial Design

  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. A Multiple Sclerosis Clinical Trial Collaboration

    Managing multiple outcome measures and rapid patient recruitment for Phase IIB clinical trial on targeting relapse-remitting Multiple Sclerosis

  4. How To Accelerate Trial Enrollment: What Works And What Doesn’t

    As you evaluate clinical trial enrollment acceleration strategies, be sure to understand the root causes of slow enrollment and the reasons why traditional acceleration programs do not work. 

  5. 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.

  6. Message To ClinOps Leaders: The Organizational Planning Textbook Wasn’t Written For This!

    Five considerations to help organizations make better planning and forecasting decisions in an environment with such strict parameters.

  7. Solution Provider Submits Periodic Adverse Drug Experience Reports (PADERs) For A Multinational Specialty Pharmaceutical Company

    Submission of PADERs to the FDA is required during post-marketing drug safety surveillance. Instill confidence in your results and regulatory submissions by partnering with an experienced partner.

  8. Pharmacovigilance As-A-Service (PVaaS) Provides Key End-To-End Support To Meet Pharmacovigilance Needs For A Specialty Pharmaceutical Company

    PV activities will continue to grow in volume and complexity. Trusting an experienced partner to help manage PV requirements can free your team to concentrate on patient efficacy outcomes.

  9. Clinical Services Company Eliminates Drug Supply Waste

    How the use of tools can enable your objective of ensuring patient safety by having the right amount of material available with an appropriate investment in inventory cost.

  10. The Treacherous Study Startup Journey

    With spiraling costs and increasing stakeholder demands, it’s critical that studies get off to the right start.