REGULATORY INSIGHTS

  • Driving Product Development And Finding The Fast Track In Early-Phase Oncology Programs

    Explore the many aspects a company must consider in planning and executing an early-phase oncology trial of this hypothetical compound, from performing a regulatory gap analysis and developing a target product profile to identifying the right patients and selecting efficacy endpoints.

  • 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.

  • One Source Drives One Process For Clinical Trial Transparency

    Sponsor was challenged with lengthy, resource-intensive processes to support compliance in clinical trial registration and results reporting.

  • Improving Compliance While Reducing Resources

    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).

  • 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.

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REGULATORY MULTIMEDIA

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REGULATORY SOLUTIONS

  • Ten Big Questions To Ask Your Clinical Transparency Solution Partner

    When considering clinical trial disclosure solutions, it is important to understand the potential partner’s practical experience and how their solution fits your compliance needs today and in the future.

  • TrialScope Transparency Management Brochure

    TrialScope Clinical Trial Transparency Service (CTTS) enables clinical trial sponsors to engage with patients and the public via a user-friendly, high impact website to openly share clinical trial information and results, demonstrating leadership in transparency while optimizing trial recruitment and retention.

  • TrialScope Disclosure Management
    TrialScope Disclosure Management

    PharmaCM is a clinical trial disclosure platform designed specifically for the regulated environment of Life Sciences. PharmaCM is used to manage the complex process of authoring, reviewing, editing, approving and publishing clinical trial application and disclosure data. Disclosure content is very dynamic. Clinical trial data is constantly being updated, modified and formatted for specific registries such as ClinicalTrials.gov and EudraCT.

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