Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• The Role Of The Technical Transfer Executive Sponsor

  Explore the importance of understanding a CDMO’s flexibility and culture, models and scale of equipment, technical capabilities, regulatory support, quality system, and executive sponsorship model.

• The Digital Transformation Of A Leading CDMO's Process Development Lab

  Discover how a leading CDMO was able to create a data model for its bioreactors, resulting in easily contextualized data, time savings in manual tasks, and the ability to share insights in real time.

• 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.

• 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.

• Regulatory Considerations For Excipients Used In Lipid Nanoparticles

  Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

• Solving Imminent Regulatory Challenges With Single-Use Technologies

  Here, we explain how companies using mRNA vaccine technology can address compliance challenges through single-use technologies.

• 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.

• 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.

• Gateways To Asia: Market Access In Japan And South Korea

  Learn how the recent developments in market access and regulatory rules in Japan and South Korea have paved the way for expansion in Asia.

• An Introduction To Passive Radar Systems

  Dive into the concept and operating principles of passive radar systems, review the basics of bistatic radars, and introduce the concept of emitters of opportunity (EoO) and their ideal qualities.

• Case Study: Recruiting Pediatric Ultra-Rare Disease Patients

  Explore how Rezolute was able to overcome challenges while recruiting pediatric patients for a Congenital Hyperinsulinism (HI) clinical trial using a streamlined, single-source tool.

• IT Changes Implemented To Overcome Future Manufacturing Challenges

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