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WHITE PAPERS AND CASE STUDIES

• NDA Success Strategy: Using Non-US Clinical Data In An NDA Submission

  A sponsor acquiring a therapeutic asset from an overseas company sought assistance when including foreign clinical trial dat,a generated outside a U.S. IND, in a New Drug Application (NDA).

• Flexible Integrations To Reduce Risks And Increase Efficiencies

  Learn how a trial team kept the blind of central lab samples and patient treatment across a Phase III and extension trial, whilst optimizing the supply chain.

• Microbial Challenge In-Use Studies

  Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.

• Why Early Market Access Planning Is Crucial In CGT Commercial Strategy

  Bringing cell and gene therapies (CGTs) to market and ensuring patient access is a complex process. Discover how developing a market access strategy and partnering with experts can help.

• Selecting A New Sporicidal Disinfectant: What The Cleanroom Manager Needs To Know

  This guide helps cleanroom managers evaluate sporicides by efficacy, safety, and compatibility to ensure contamination control without compromising operational integrity.

• Response To FDA Black Box Warning

  The FDA has launched an investigation into the risk of T-cell malignancies following CAR-T cell immunotherapies. Review the key points of this announcement concerning the CGT research community.

• Designing, Selecting, And Developing Bioconjugates For Clinical Success

  Accelerate the development of complex bioconjugates to unlock new possibilities for targeted therapies and advance the next generation of precision medicine.

• Relieving The Strain Of Publishing During Regulatory Registration

  Go inside how an expertly handled NDA submission for a biopharma company ensured timely FDA approval despite challenges.

• Expert Guidance For EU Gene Therapy And Companion Diagnostic Trial Regulations

  This playbook provides a concise yet comprehensive roadmap for navigating Europe’s multifaceted regulatory environment when conducting gene therapy trials involving GMOs and CDx.

• How LIMS Supports QC Scaling At Forge Biologics

  Modernizing QC workflows with cloud-based systems eliminates paper inefficiencies, reduces errors, and accelerates reporting. Discover how streamlined processes improve compliance and enhance data visibility.

• Fortrea Optimizes Site Matching On Retina Clinical Trials

  Faced with challenges in engaging clinical trial sites within the retina research landscape, Fortrea sought a partnership that leverages RWD to streamline site feasibility assessments.

• NuGenesis 9.3 – What's New

  Explore the latest features of a user-centric lab management system that comprises data, workflow, and sample management capabilities to support the entire product lifecycle.