Catalysts

WHITE PAPERS AND CASE STUDIES

• Supporting Participants Through National Travel Disruptions

  A sudden travel shutdown threatened a critical clinical visit. Rapid rescheduling, coordinated logistics, and clear communication ensured engagement and the ability to continue without interruption.

• Rapid Results In A High-Stakes Dry Eye Disease Trial

  This time-sensitive Phase 3 trial in dry eye disease required precision project management leveraging strong site relationships, ophthalmology-specific expertise, and data-driven site selection.

• High Drug Tolerance ADA Testing For Long‑Acting mAbs

  See how advanced ADA assay design overcomes extreme drug interference, enabling reliable immunogenicity assessment for long‑acting, high‑dose monoclonal antibodies in early clinical development.

• Using Virtual Study Coordinators For EDC Entry And Query Resolution To Speed Up Data Access And Cleaning

  The piece showcases how the effective use of CRIO can significantly enhance site performance, supporting recruitment and diversity objectives for sponsors.

• Why A Leading Manufacturing Partner Chose NeoTOP Packaging Machines

  Learn how a leading CDMO partnered with Körber to quickly deploy a high-speed packaging solution to meet tight production deadlines in the face of a global pandemic.

• Overcoming Rapid Growth Challenges With Process Liquid Preparation

  With a helpful assessment and the right process liquid preparation services, the CDMO featured in this study was able to find a path toward meeting the surge in demand for a client's therapeutic .

• Strategic Pre-IND Consulting For Gene Therapy In Rare Leukemia

  Learn about the collaborative efforts of an innovative biotech startup and Ergomed Consulting to overcome challenges in the pre-IND phase for a novel gene therapy targeting a rare form of leukemia.

• How Bend Bioscience Standardized Operations And Boosted Compliance

  Discover how Bend Bioscience replaced its outdated CMMS with RAM to achieve rapid compliance, boost efficiency across facilities, and cut operational costs by 25%.

• What Unified eCOA And IRT Can Unlock

  See how real-time scoring and automated eligibility checks helped a global dermatology study reduce site burden, avoid manual errors, and move participants through screening with greater speed.

• Monitoring Laser Power In Laser-Based Fill & Finish Biopharmaceutical Systems

  Custom laser power measurement ensures precise vaccine vial sealing, meeting strict biopharma compliance standards through tailored detectors, firmware, and calibration for critical fill-finish applications.

• Re-Engineering A Complex Process For FDA Compliance

  Discover the strategies that helped a company navigate a complex and shifting regulatory landscape to rapidly re-engineer a COVID-19 vaccine manufacturing process for FDA compliance.

• From Lab To Tox Batch: A First-Time-Right API Scale-Up

  Gain insight into a first-time-right process that improved yield and scalability, advancing a vascular calcification inhibitor from lab scale to tox and GMP manufacturing for clinical development.