TrialScope Blog

The TrialScope team discusses clinical trial disclosure and compliance topics

  • Improving Health Through Participation in Clinical Trials

    Improving Health Through Participation in Clinical Trials

    Clinical trials not only help older adults learn more about their disease, they can help others too. But barriers such as unclear communication and lack of patient engagement hinder participation.

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  • SEO, UX Key to Finding – and Understanding – Clinical Trials

    SEO, UX Key to Finding – and Understanding – Clinical Trials

    Sponsors’ clinical trials websites should focus patient-centric content and design, navigation and mobile friendliness. This is where user experience (UX) and user interface (UI) come into play.

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  • Meeting the EU CTR Compliance Challenge Head-On

    Meeting the EU CTR Compliance Challenge Head-On

    Looking at public data on EU CTR as of July 16, a TrialScope analysis found a total of the over 16,000 clinical trials that ended more than 12 months earlier, only around 10,000 had results posted.

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  • Clinical Trial Websites: Challenging the Status Quo

    Clinical Trial Websites: Challenging the Status Quo

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  • 2 Steps for Correcting Non-compliance with EU Disclosure Regulations

    2 Steps for Correcting Non-compliance with EU Disclosure Regulations

    On the EU CTR registry, many clinical trial results unavailable, and it appears many studies were registered but never updated. Here's a two-step process on how to correct this non-compliance.

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  • Survey Reveals Plain-Language Commitments Still Evolving

    Survey Reveals Plain-Language Commitments Still Evolving

    Results of a recent TrialScope survey reveal that most sponsors are committing to providing plain-language summaries for Phase 2 – 4 clinical trials, with some extending to Phase 1 studies.

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  • Top 5 Best Practices for Clinical Disclosure SOPs

    Top 5 Best Practices for Clinical Disclosure SOPs

     

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  • Trial Sponsors Take Control NOW!

    Trial Sponsors Take Control NOW!

      Two Steps to EU Results Disclosure Compliance Background European Union regulations require the disclosure of clinical trial results for all studies within 12 months of study...

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  • How Solid Is Your Corporate Transparency Reputation?

    How Solid Is Your Corporate Transparency Reputation?

      Increasing demands for clinical trial disclosure and transparency are dominating the medical journals and making their way into more general news outlets as well. Recently, Dr Ben...

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  • Final Rule Results - What You Need to Know

    Final Rule Results - What You Need to Know

    On January 18, 2018, results for applicable clinical trials (ACTs) with a primary completion date on or after January 2017 start becoming due under 42 CFR Part 11 for Clinical Trials...

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  • The BMJ Audit That Will Make Sponsors Rethink Their Transparency Policies

    The BMJ Audit That Will Make Sponsors Rethink Their Transparency Policies

    The recent article in the BMJ on Pharmaceutical companies’ policies on access to trial data, results, and methods, is an interesting next step in the evolution of publicly disclosing...

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  • Noncompliant Clinical Trial Transparency

    Noncompliant Clinical Trial Transparency

    OVERVIEW: Regulatory Risk is the possibility that changing regulations will significantly affect the organization, requiring additional investments, changes in operations, or other...

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  • Major Funders Get Serious About Clinical Trial Transparency

    Major Funders Get Serious About Clinical Trial Transparency

    INTRODUCTION: Medical research funders like the Wellcome Trust, the Bill and Melinda Gates Foundation, and others are getting serious about clinical trial transparency. On May 18,...

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  • Uncontrolled Transparency

    Uncontrolled Transparency

    Operational Risks Overview Operational Risks is the possibility of issues arising from inadequate policies or procedures, poor data quality, insufficient systems, and human error. ...

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  • Expanding Transparency

    Expanding Transparency

    The growing scope of global disclosure

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  • Atlas Global Compliance: Disclose Locally, Comply Globally

    Atlas Global Compliance: Disclose Locally, Comply Globally

    Discussions with TrialScope customers and others have confirmed that challenges with global clinical trial disclosure are prevalent across organizations, regardless of size.  There are...

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  • Tips to Comply with Final Rule Clinical Trial Disclosure Requirements on April 18

    Tips to Comply with Final Rule Clinical Trial Disclosure Requirements on April 18

    April 18, 2017 is the date that your studies must comply with the Final Rule…are you ready?

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  • What's New in the ClinicalTrials.gov PRS for April 18, 2017

    What's New in the ClinicalTrials.gov PRS for April 18, 2017

    On Thursday, April 6th, the ClinicalTrials.gov team announced changes that are scheduled to go live on April 18, 2017, to support the Final Rule compliance date.

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  • 8 Benefits for Clinical Trial Sponsors Using TrialScope's Trial Results Summaries Portal

    8 Benefits for Clinical Trial Sponsors Using TrialScope's Trial Results Summaries Portal

    INTRODUCTION: Clinical Trial Sponsors are looking to provide Trial Results Summaries, also known as “Lay-Language Summaries” or “Plain-Language Summaries”.  TrialScope recently...

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  • 6 Ways Patients Win with TrialScope's Trial Results Summaries Portal

    6 Ways Patients Win with TrialScope's Trial Results Summaries Portal

    INTRODUCTION: Trial Results Summaries, also known as Lay-Language Summaries, or Plain-Language Summaries are documents that provide the results of a clinical trial in non-technical...

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