Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• A Digital Solution Embeds Quality Into Cellular Therapeutics Production

  Discover how Dendreon cut review and release time by nearly 50% while maintaining a 99% right-first-time rate, which boosts collaboration, visibility, and operational efficiency across teams.

• Patient-Defined Recruitment: The Movement Advanced By COVID-19

  The pandemic forced the pharmaceutical industry to reimagine how we recruit patients to clinical trials – and it's delivering significant benefits to sponsors who embrace these changes.

• The EMR Interoperability Dream Vs. Clinical Research Reality

  Seamless Electronic Medical Record access promises accelerated trials and regulatory-grade evidence, but incomplete, unstructured data requires hybrid strategies using AI and human oversight to bridge gaps.

• Process Scale Column Packing Instructions

  Explore a comprehensive guide to using DurA Cycle A50, a high-capacity, alkaline stable protein A affinity chromatography resin for the downstream processing of mAbs and recombinant proteins.

• 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).

• Rescuing Data Integrity: A Swift Transition And Quality Transformation

  Uncover how this collaboration supported timely progress toward key study milestones, enabling smoother execution and more dependable output across data management and statistical activities.

• FDA's Regenerative Medicine Advanced Therapy (RMAT) Program

  RMAT qualification requires preliminary clinical evidence demonstrating the potential to address an unmet medical need. This designation grants benefits like intensive guidance and faster FDA review.

• How To Avoid Sticking And Picking In The Tableting Industry

  Review strategies to mitigate sticking and picking risks in the tablet industry, and learn how you can foster improved tablet production processes, ensuring higher quality and consistency.

• Avoiding The Pitfalls Of PQR

  Explore the fundamentals of Product Quality Reviews (PQRs), common challenges manufacturers face, strategies for streamlining PQRs, and solutions that aim to unlock the potential of a "real-time PQR."

• Cell Line Development: The Linchpin In Biotherapeutic Development

  Review key factors for building a reliable CLD strategy, and learn how the right CDMO can help you achieve the high quality, high yield, and speed needed to successfully bring a biologic to market.

• Partnering For Precision In An IPF Study: Securing Timely Deliverables And Key Endpoints

  A pharmaceutical company enlisted Worldwide Clinical Trials to help achieve on-time results for their Phase IIa IPF clinical trial, enabling them to manage vendors and meet challenging deadlines.

• Optimizing AAV Purification for High Recovery

  How can you improve purification methods for your AAVs and enhance the efficacy and safety of your gene therapy treatments?