Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Modern Lentiviral Platforms For Scalable Cell Therapy

  A new platform approach streamlines lentiviral vector design and manufacturing, boosting yield, lowering costs, and accelerating access to gene‑modified cell therapies worldwide.

• Disclosure Management System: Build Or Buy?

  Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.

• Cell Line Development: The Linchpin In Biotherapeutic Development

  Review key factors for building a reliable CLD strategy, and learn how the right CDMO can help you achieve the high quality, high yield, and speed needed to successfully bring a biologic to market.

• 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.

• The Latest Trends In The Prevention And Treatment Of Cervical Cancer

  What immune checkpoint inhibitors are showing promise in cervical cancer treatments and how are advancements in treatment, paired with additional prevention strategies, improving patient outcomes?

• 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.

• 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.

• How LIMS Supports QC Scaling At Forge Biologics

  Modernizing QC workflows with cloud-based systems eliminates paper inefficiencies, reduces errors, and accelerates reporting. Discover how streamlined processes improve compliance and enhance data visibility.

• GMP Calibration Management

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

• FDA's Regenerative Medicine Advanced Therapy (RMAT) Program

  RMAT qualification requires preliminary clinical evidence demonstrating the potential to address an unmet medical need. This designation grants benefits like intensive guidance and faster FDA review.

• 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.

• 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).