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Maximize Efficiency with Our Expert Solutions

Elevate Your TrialAssure Platform with Our Services

TrialAssure tools and AI technology are here to help to maximize your transparency and compliance efforts. However, in some cases, there is no substitute for the counsel of trusted professionals that understand both the evolving regulatory landscape and the advanced technology driving industry innovation. Our team is uniquely positioned to provide strategic insights and support, helping you stay ahead of industry trends and standards while ensuring the successful integration of AI Enabled, Human Driven™ solutions into your processes.

Revolutionizing Clinical Trial Transparency trialassure results disclosure registration anonymization redaction plain language summaries lay summaries TrialAssure® is a global, award-winning clinical trial and human health data transparency software suite. TrialAssure helps meet regulatory compliance goals through a flexible, scalable, and streamlined software-as-a-service (SaaS) platform that supports risk-based dataset and document anonymization, data-driven plain language summaries, and clinical trial registry activities.

Clinical Trial Disclosure and Transparency Services

  • Advisory Services

    At TrialAssure, we seamlessly partner with you to act as your outsourced transparency department. With more than 15 years of experience working with regulators, registries, and patient advocates, our team is uniquely equipped to:

    • Author high-quality Plain Language Summaries in adherence to necessary 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. 

    Proprietary 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 partner 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

    Through partner support, we help you achieve and surpass clinical trial disclosures reporting requirements for ClinicalTrials.gov, the EU CTIS, 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, these seasoned experts are 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 Communication and Engagement Services

    Ensure that your operating procedures reflect your core values and commitment to patients and the community. Through a preferred partner, 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. 

    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. 

    Contact us if you need support with: 

    • 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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  • AI Tool Development

    At TrialAssure, we offer comprehensive AI tool development and support services designed to accelerate your adoption of advanced AI technologies. Our team of industry experts helps you build and implement scalable, customizable AI solutions tailored to your specific use cases, whether in clinical research or in a variety of other industries, including government, finance, legal, and others. With our proven platforms like LINK AI, we deliver high-value generative AI capabilities that optimize processes, reduce time-to-value, and minimize the risks associated with building AI tools from scratch. From initial ideation to ongoing support, we provide you with the technical expertise and resources needed to enhance efficiency, cut costs, augment your internal teams, and ensure compliance with global standards.