Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• CRO Leverages Integrated Central IBC Partnership To Initiate Sites

  Learn how a CRO was able to accelerate review times so COVID-19 vaccine trial sites could progress through site selection, IRB/IBC submission, approval, drug shipment, and complete site initiation visits in record time.

• Overcoming Known Pharmacological Effects

  Uncover how our team was able to address the challenges of evaluating treatments that reduce food consumption and cause body weight loss while ensuring animal health and study integrity.

• 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.

• 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.

• Optimizing AAV Purification for High Recovery

  How can you improve purification methods for your AAVs and enhance the efficacy and safety of your gene therapy treatments?

• Advancing Dose Escalation Strategies With Bayesian Modeling

  A CRO was engaged to help a biotechnology sponsor develop a novel oncology therapy design and execute a multicenter, open-label Phase 1/2 dose escalation and expansion study in advanced solid tumors.

• HVLD Technology Pre-Filled Syringe Inspection

  Advanced HVLD technology delivers non-invasive, deterministic inspection for pre-filled syringes. Learn how this method improves reliability and patient safety compared to traditional approaches.

• Cleanroom Recovery. Proven Results. Contamination Control Case Studies

  Through this collection, review how a proven, automated solution can help facilities stay compliant, operational, and protected — whether in a crisis or during planned maintenance.

• Pharma R&D Review 2024: Pleasant Weather Ahead

  Gain insights from the 2024 pharma landscape, which reports a record-breaking 22,825 pipeline drugs, led by Pfizer's 32 new candidates and a strong focus on oncology and neurological treatments.

• Achieving Faster Timelines And Cost Savings Through Digital Validation

  Examine how the Project Ready program was leveraged to streamline validation processes for a CDMO, resulting in a 25% reduction in budget and faster project completion.

• 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).

• BSL-3 Mobile Biocontainment Laboratory For Vaccine Development Research

  The client required a freestanding COVID-19 research facility on an accelerated timeline built for continuous use in the cold climate of the northeast United States without a shell building.