WHITE PAPERS AND CASE STUDIES

• 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.

• Eliminating The Guesswork From Critical Decision Making

  By leveraging a unified platform, see how this sponsor was able to overcome the logistical complexities of patient randomization, streamlining, and condensing processes.

• Designing, Selecting, And Developing Bioconjugates For Clinical Success

  Accelerate the development of complex bioconjugates to unlock new possibilities for targeted therapies and advance the next generation of precision medicine.

• 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.

• 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. 

• Microbial Challenge In-Use Studies

  Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.

• Performance Dashboards Development

  Learn about a biotech company's successful implementation of a two-level KPI dashboard system. This enhanced performance monitoring, aligned departmental goals, and strengthened team communication.

• Why Early Market Access Planning Is Crucial In CGT Commercial Strategy

  Bringing cell and gene therapies (CGTs) to market and ensuring patient access is a complex process. Discover how developing a market access strategy and partnering with experts can help.

• How To Manage A Drug Product In A Medical Device Environment

  Discover how ProPharma successfully ensured GMP and GDP compliance for a drug product within a medical device environment.

• Accelerating SARS-CoV-2 Immunotherapy Speed To Clinic

  A clinical-stage biotherapeutics company developing a COVID-19 immunotherapy searched for a solution to the difficulties it faced in scaling up its manufacturing operations due to limited resources.

• 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.

• Early-Stage Development In Rare Pediatric Oncology

  Learn about the strategic approach a biotechnology company utilized to address significant hurdles in launching a Phase 1 clinical trial for a novel therapy targeting a rare pediatric cancer.