Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• 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.

• 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.

• 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).

• Innovative ASD Technology Improves Abandoned Cancer Medication

  Review this case to learn how one solid dispersion technology lowered patients' pill burdens and demonstrated an improved therapeutic response for Galeterone.

• Earning RMAT Designation - What Developers Need To Know

  Explore a high-level overview of the Regenerative Medicine Advanced Therapy designation and how to ensure success and accelerate advanced therapy products toward commercialization.

• Phase 1 Clinical Trial Designs And Strategies

  With tailored guidance, sponsors can align their modern model-based and model-assisted design choices to program goals, accelerating progress while safeguarding patients.

• 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.

• 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."

• Retrofit Of A Brand New Pump Station

  Due to clogging problems, a pump station was experiencing reduced pump performance, longer pump run times, significant vibration issues, and the need to be physically unclogged. 

• Expanding Diabetes-Related Eye Health Equity

  20/20 Onsite, American Diabetes Association and Genentech collaborated on an event to provide immediate diagnostic services, including retinal imaging and visual acuity assessments, directly on-site.

• A Solid Solution And Impeccable Service Wins Over This Client

  In this case study, learn why Canada's oldest cheese company looked to Newterra for systems and support.

• A Comprehensive Planning Approach For Cancer Antibody

  Discover how a clinical-stage biotech company was able to accelerate pathways for development and regulatory review of their first Phase 1 protocol for an immuno-oncology antibody.