Regulatory, Strategies & Submissions

Overcome the obstacles to get products to market faster and smarter.

  • RWE in an evolving regulatory landscape: Using real-world evidence to support novel product development pathways

    RWE in an evolving regulatory landscape: Using real-world evidence to support novel product development pathways

    In this on-demand webinar, Parexel experts discuss the growing interest in RWE from both regulators and payors and the advantages of using real-world data (RWD) to streamline the research process.

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  • Cell and Gene Therapy & Tissue Engineering

    Cell and Gene Therapy & Tissue Engineering

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  • Agency Readiness – Bob Iser2:48

    Agency Readiness – Bob Iser

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  • Accelerated Pathways – Alberto Grignolo2:55

    Accelerated Pathways – Alberto Grignolo

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  • Strategies for Working with Global Regulatory Agencies

    Strategies for Working with Global Regulatory Agencies

    Early engagement with regulatory authorities can help boost regulatory success rates and also help shorten clinical development timelines.

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  • Liquent InSight®: The Right Choice for Regulatory Information Management

    Liquent InSight®: The Right Choice for Regulatory Information Management

    Read why 18 of the top 20 pharmaceutical companies are using a module of the Liquent InSight® platform as their single, authoritative source for regulatory information.

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  • Phase III Trial Failures: Costly But Preventable

    Phase III Trial Failures: Costly But Preventable

    This article examines reasons for the high failure rate of Phase III studies and innovative approaches companies can take to mitigate risk.

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  • Three Steps for Filling Real-World Evidence Gaps

    Three Steps for Filling Real-World Evidence Gaps

    Create a strong RWE evidence strategy that addresses three critical factors: product differentiation, clinical outcomes in the real world and evidence gaps that may crop up suddenly.

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