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WHITE PAPERS AND CASE STUDIES

• The Role Of A Consulting Firm In The IND Process

  Navigate the complex IND process with expert guidance and discover how early FDA engagement can accelerate your path to clinical trials.

• 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.

• 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.

• 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.

• Taking Research In-House With CRIO: SciTech's Multi-Center Phase 1 Study

  Explore the success story of an early-stage clinical pharmaceutical company that effectively navigated funding constraints when conducting its Phase 1 study without a third-party CRO. 

• Improving Patient Health and Safety: Quality and Analytical Scientist

  Explore how an analytical scientist enhanced quality and compliance for a pharmaceutical company by managing complex analytical testing and vendor interactions.

• Achieving Faster Timelines And Cost Savings Through Digital Validation

  Examine how the Project Ready program was leveraged to streamline validation processes for a CDMO, resulting in a 25% reduction in budget and faster project completion.

• Project Orbis Drug Registration 2025

  Project Orbis helps streamline the review and approval of oncology medicinal products through international regulatory collaboration. Learn how this framework can accelerate your regulatory strategy.

• Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration

  A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Discover how integrating an innovative strategy transformed their workflow.

• CRO Leverages Integrated Central IBC Partnership To Initiate Sites

  Learn how a CRO was able to accelerate review times so COVID-19 vaccine trial sites could progress through site selection, IRB/IBC submission, approval, drug shipment, and complete site initiation visits in record time.

• 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.