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WHITE PAPERS AND CASE STUDIES

• Improving Patient Health And Safety: Medical Safety Scientist

  See how this experienced safety scientist managed benefit-risk assessments and pharmacovigilance while streamlining product development and lifecycle management for a pharmaceutical company.

• RNA: The Next Era In Therapeutic Development

  Review the unique set of challenges for RNA production that must be considered and solved to reach their full therapeutic potential.

• 2025 Trends In Patient Recruitment: From Disruption To Precision

  Explore the four macro trends reshaping the recruitment space in 2025—each grounded in emerging data, technology, and behavior shifts.

• FDA Recommendations For Gene Therapy For PMDs

  Explore insight into the strategies and FDA recommendations for executing gene therapy development programs, specifically for primary mitochondrial diseases (PMDs).

• Topliss Sets In Drug Design Technical Notes For The Medicinal Chemist

  When considering new, innovative, and efficient drug design processes, you may want to review Professor J G Topliss's non-mathematical operational schemes for analogue design.

• Expert Consulting And MRCT Strategy Rescues Oncology Program

  Uncover how this strategic approach yielded significant outcomes, including uncovering missing data through IB review, streamlining dosing timelines, and achieving successful recruitment milestones.

• Organizational Assessment For A Large MedTech Company

  Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.

• Container Selection For A Highly Sensitive Drug Product: A Success Story

  Learn about the importance of selecting the right container for sensitive drug products and how close collaboration is crucial for avoiding commercialization delays and safety risks to patients.

• IT Changes Implemented To Overcome Future Manufacturing Challenges

  Learn how Pfizer and Ferring improved their reporting and batch information management with Rockwell’s technology.

• Strategic Pre-IND Consulting For Gene Therapy In Rare Leukemia

  Learn about the collaborative efforts of an innovative biotech startup and Ergomed Consulting to overcome challenges in the pre-IND phase for a novel gene therapy targeting a rare form of leukemia.

• Supporting A Company In Manufacturing The RSM For Treating A Rare Tumour

  A clinical-stage oncology company needed a partner to manufacture the RSM. Examine how an optimized RSM manufacturing process helped deliver safe, effective treatment on an accelerated timeline.

• Navigating The Complexities Of CGTs With Regulatory And CMC Expertise

  Review the submission process and CMC expertise which helped a biopharmaceutical company targeting a rare-disease tumor type avoid a clinical hold and advance to phase 1 clinical trials.