Insights On Trial Design

  1. Improving Compliance While Reducing Resources
    10/4/2018

    A global sponsor organization that develops pharmaceuticals, biologics, medical devices and over-the-counter products, sought a better approach to clinical trial registration and results disclosure requirements in the US. Using templates and spreadsheets, the sponsor team was spending approximately 20 hours to draft, finalize, approve and release one initial study registration to the US clinical trial registry (www.clinicaltrials.gov).

  2. Clinical Trial Transparency: The Technology Imperative
    10/4/2018

    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.

  3. A Multiple Sclerosis Clinical Trial Collaboration
    10/4/2018

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

  4. Syncing Transparency Processes To Improve Clinical Trial Compliance
    10/3/2018

    The Sponsor’s current system required redundant data entry, consisted of disjointed tools, and was a drain on valuable resources.

  5. 2 Steps For Correcting Non-Compliance With EU Disclosure Regulations
    10/3/2018

    To address non-compliance and improve the ratio of completed trials with results, we recommend the following two-step process to take control of your compliance.

  6. How To Accelerate Trial Enrollment: What Works And What Doesn’t
    9/27/2018

    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. 

  7. A Build Vs. Buy Look At Study Activation
    9/12/2018

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

  8. Message To ClinOps Leaders: The Organizational Planning Textbook Wasn’t Written For This!
    9/6/2018

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

  9. Solution Provider Submits Periodic Adverse Drug Experience Reports (PADERs) For A Multinational Specialty Pharmaceutical Company
    9/4/2018

    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.

  10. Pharmacovigilance As-A-Service (PVaaS) Provides Key End-To-End Support To Meet Pharmacovigilance Needs For A Specialty Pharmaceutical Company
    9/4/2018

    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.