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Expertly Crafted Clinical Trial Compliance Solutions You Can Trust

Elevate Your TrialAssure Platform with One or More of Our Services

The TrialAssure suite is a powerful set of tools to maximize your clinical trial disclosure and transparency efforts. However, in some cases, there is no substitute for the counsel of trusted professionals that understand the transparency requirements and the software that enhances those efforts. Our team of experts is uniquely positioned to provide your organization with guidance to stay on the cusp of industry trends, standards, and regulations.

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Clinical Trial Disclosure and Transparency Services

  • Advisory Services

    At TrialAssure, we consider ourselves to be the outsourced transparency department for our clients. With over a decade of experience working with regulators, registries, and patient advocates, TrialAssure is uniquely equipped to:

    • Authoring of high-quality Plain Language Summaries in adherence to EU guidelines
    • Design and implement an end-to-end disclosure and transparency strategy and governance
    • Help you disclose clinical trial information accurately and efficiently
    • Summarize your study data for registry submission
    • Work with your clinical and transparency teams to ensure accuracy and compliance
    • Facilitate review cycles, quality control checks, final approval, and registry submission
    • Respond to queries from governing bodies

    Our team is available to support in all areas of transparency on a global level.

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  • Anonymization and Redaction Services

    TrialAssure is a pioneer of risk-based clinical trial document, data, and image anonymization, with industry thought leadership and the use of advanced tools to achieve both efficiency and quality with every deliverable.

    Internal anonymization processes and tools are designed to maximize data utility and protect patient privacy, while offering:

    • Process development inclusive of “transparency ready” templates
    • Data anonymization (or de-identification)
    • Document anonymization and/or redaction
    • Risk of re-identification assessment for anonymized data
    • Risk of re-identification for anonymized or redacted documents

    This flexibility is key in preparing for transparency initiatives, such as big data projects, compliant to EMA Policy 0070 or HC PRCI, and data sharing or collaboration with researchers.

    To ensure the highest level of utility, all data anonymization support is performed by a cross-functional team, including clinical trial data analysts, biostatisticians, and medical writers, with the ability to anonymize or de-identify studies in batches.

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  • Clinical Trial Disclosure Services

    TrialAssure helps Sponsors achieve and surpass clinical trial disclosures reporting requirements for ClinicalTrials.gov, the European Union Clinical Trials Register (EU CTR), and other international registries. An integrated disclosure solution allows TrialAssure to be your centralized transparency department and manage all workflow and data summarization obligations for an entire pipeline. As legislation increases in complexity, our team of experts is here to automate and manage compliance.

    Partnering with TrialAssure provides:

    • Simple workflows to progress studies through the disclosure lifecycle
    • Insights into transparency requirements for all global registries
    • The ability to share data with multiple registries from a single dataset
    • Automatic calculation for all disclosure due dates
    • Customized reports to evaluate compliance risks and identify bottlenecks in operational processes
    • Recommendations for best practices based on our industry expertise and knowledge
    • Standard Operating Procedures (SOPs) and organizational structure, if needed
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  • Patient Communications and Engagement Services

    TrialAssure helps Sponsors ensure that their operating procedures reflect their core values and commitment to patients and the community. We conduct a thorough analysis of all policies, standard operating procedures (SOPs), and guidelines to identify improvement opportunities, address compliance bottlenecks, and recommend a strategy for improvement.

    With TrialAssure as your transparency partner, you can be confident that we are maintaining industry compliance and incorporating best practices for enhanced transparency with patients, caregivers, and the community.

    Partnering with TrialAssure provides:

    • SOP development and consulting
    • Patient communication template and guidance document development for plain language summaries and ongoing communications
    • Review of patient-facing materials (Informed Consent Forms)
    • Graphic design and layout
    • Developing and maintaining training material for writers, reviewers, and Sponsors
    • Maintenance of best practices document based on industry trends and regulatory guidance
    • Lay review
    • Patient advocacy review
    • Distribution via patient communication portal
    • Printing of patient communications
    • Translation services
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