Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• How Vanguard Clinical Harnesses CDMS/EDC For Faster Results

  Uncover how this CRO was able to stay agile by choosing a CDMS/EDC partner that prioritized sponsor needs and streamlined operations to achieve top-tier results swiftly.

• Project Orbis Drug Registration 2025

  Project Orbis helps streamline the review and approval of oncology medicinal products through international regulatory collaboration. Learn how this framework can accelerate your regulatory strategy.

• 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.

• 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.

• Handling Demanding Active Ingredients Safely And Efficiently

  See three flexible Optima fill‑finish and syringe assembly systems to boost performance, accuracy, and scalability, enabling efficient processing of diverse formats and supporting rapid CDMO growth.

• Process Scale Column Packing Instructions

  Explore a comprehensive guide to using DurA Cycle A50, a high-capacity, alkaline stable protein A affinity chromatography resin for the downstream processing of mAbs and recombinant proteins.

• eSource Purpose Is Not Just To Complete The EDC

  Central eSource transforms data capture from a passive, back-end chore into an active, real-time quality and compliance engine—delivering benefits that extend beyond faster EDC feeds and reduced SDV.

• Streamlining Single-Use Assemblies In The Bulk-Fill Step Of Downstream Processing

  Single-use (SU) systems and components are growing in demand as they offer minimal contamination risk. Review a standardized SU assembly for bulk-fill processing that aims to improve efficiency.

• Streamlining Early-Phase Oncology Study Start-Up In Today's Clinical Environment

  Explore the significance of targeted therapies and adaptive trial designs that prioritize patient-specific characteristics.

• 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.

• GMP Calibration Management

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

• 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.