Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Flexible Integrations To Reduce Risks And Increase Efficiencies

  Learn how a trial team kept the blind of central lab samples and patient treatment across a Phase III and extension trial, whilst optimizing the supply chain.

• Biostatistics And Programming — More Than Just Clinical Trials

  See how our biostatisticians and programmers successfully ingested, cleaned, and analyzed the data, ultimately providing a small biotech company with several interesting and actionable measures.

• 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.

• Stopper Migration In Frozen Pre-Filled Syringes

  Review a semi-automated method for dynamically assessing plunger migration under controlled variations in temperature and pressure, utilizing computer vision tools.

• What Re-Acquisition In Retinal Imaging Is Really Costing Your Program

  High screen failure rates and patient dropout often stem from preventable imaging errors. Learn how proactive quality control and patient-centric logistics secure critical retinal trial data.

• Quantitation Of Monoclonal Antibodies In Serum

  Monoclonal antibodies (mAbs) are a rapidly growing group of targeted therapeutics. Gain insight into the importance of optimized bioanalytical assay platforms for mAb development.

• 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.

• Unveiling The Critical Role of Sleep In Clinical Studies

  Explore the critical role of sleep in clinical trials and its impact on health outcomes, emphasizing the need to address sleep disturbances for more effective and reliable research.

• 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.

• The Benefits Of End-To-End Formulation And Fill/Finish Of Biologics

  Proper formulation development has a huge impact on whether a technology transfer to clinical phase fill/finish is successful. Review the challenges of transitioning a promising drug candidate.

• 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.

• GMP Calibration Management

  Learn why generic EAM systems fall short in regulated industries and how purpose-built solutions ensure compliance, efficiency, and audit readiness.