RFICs

WHITE PAPERS AND CASE STUDIES

• Addressing Site Selection Challenges In DMD Gene Therapy Studies

  Effective site selection is critical for the success of DMD gene therapy trials. This study details innovative methodologies employed to streamline and improve site identification.

• Optimizing Kitting For Cell Therapy Trials In Pediatric Oncology

  Precision for Medicine’s Kitting team played a crucial role in overcoming this challenges of a Phase I multicenter pediatric cell therapy trial targeting relapsed or refractory solid tumors.

• ProPharma Supports A Contract Manufacturer's Form 483 Response

  Learn how a small contract manufacturer navigated a complex FDA 483 Observation notice and implemented effective remediation strategies that addressed multiple system-wide concerns.

• Trial Rescue: Leadership Approach To Propel Clinical Development

  Learn how Halloran's assistance was able to improve a rare disease biotechnology company’s development and operations, communication workflow, and avoid the delay of a gene therapy trial.

• 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.

• Elevating Downstream Process Development With Real-Time Data Monitoring

  Learn how real-time monitoring with PAT enhances process control, shortens development timelines, and supports the shift toward continuous manufacturing in biopharmaceutical production.

• Ensuring Reliability And Patient Safety With XiltriX

  Protect the integrity of your therapies and ensure patient safety by investing in reliable, real-time environmental monitoring systems that proactively address operational vulnerabilities.

• Recruiting High-Performing Sites To Beat Forecasted Trial Start Date

  Explore a partnership that enabled Syneos Health to achieve its enrollment goals, increasing the likelihood of the study's success, and resulting in cost savings and maximized efficiency with minimal delays.

• Measuring The Energy Of One Of The Most Powerful Lasers In The USA

  Gentec-EO supported a high-power laser research center with custom detectors and calorimeters, enabling precise energy measurements critical for advancing groundbreaking physics.

• Saving Dollars And Crushing Odors: How SulFeLox® Outperformed Calcium Nitrate In Tackling H2S

  Faced with increased chemical prices, a large facility in Tennessee wanted to trial SulFeLox as a potential alternative to their BIOXIDE program.

• 2nd Generation ATAD Provides Superior Treatment

  In a bold move to modernize its wastewater treatment, Bowling Green, Ohio, installed the state’s first second-generation Autothermal Thermophilic Aerobic Digestion (ATAD) system—ThermAer—in 2004. The upgrade expanded the plant’s capacity from 6 to 10 MGD and replaced an inefficient, odor-prone coarse-bubble aeration system.

• RWD's Significance In The Largest FDA-Funded IOL Study Of Pediatric Patients

  With FDA grant support, the American Academy of Ophthalmology and Verana Health conducted the largest real-world study to date on intraocular lens (IOL) use in pediatric cataract patients.