RFICs

WHITE PAPERS AND CASE STUDIES

• Navigate The Complexities Of CGTs With Regulatory And CMC Expertise

  Explore how strategic regulatory and CMC expertise helped guide a biopharmaceutical company’s regulatory and development strategy for a cell and gene therapy product.

• Secondary Packaging: Cartoning And Kitting With An Aggressive Timeline

  Meeting tight launch timelines requires more than speed. Smart kit design, controlled production workflows, and scalable processes come together to deliver complex packaging programs quickly.

• Explore A High-Performing Basal Medium And Feed Pairing

  A customer sought to replace a chemically defined CHO medium with a more efficient medium and feed pairing strategy in bioreactors.

• Resolving Odor Complaints With Targeted Solutions Restore Community Confidence

  The South Dearborn Regional Sewer District in Lawrenceburg, Indiana, provides regional wastewater treatment services for three cities and an international distillery. The 6 mgd treatment plant is located in an area of high population growth and is surrounded by many retail operations and other commercial developments. In addition, a heavily traveled state highway runs by the treatment plant.

• Metropolitan Sewer District Of Greater Cincinnati

  The Lower Mill Creek Partial Remedy (LMCPR) in Hamilton County, Ohio, is a large, complex effort to remove about 1.78 billion gallons of combined sewer overflows (CSOs) annually from the Mill Creek, an Ohio River tributary. When complete, LMCPR will improve water quality and serve as a catalyst to improve local neighborhoods.

• EHR-To-EDC Success In A Complex, Adaptive Platform Trial

  I-SPY 2, one of the longest-running adaptive platform trials in oncology, is revolutionizing breast cancer research through a dynamic, data-driven approach to evaluating novel therapies.

• Expanding Accessibility In A Phase 3 Influenza Study Through Community-Based Research

  By meeting participants where they are, this study sets a new benchmark for inclusive, efficient, and impactful vaccine development.

• Improving Patient Health And Safety

  Engage an experienced CMC program management consultant to collaboratively develop and maintain a robust product development plan (PDP) with your team lead, cross-functional members, and vendors.

• How eSource Reduced Benchmark's Protocol Deviations By Almost 40%

  Explore how a leading vaccine site network selected CRIO to help address the challenges with it's use of paper charts in collecting source data.

• Turning Continuous Acoustic Data Into Measurable Water Savings

  Aging underground infrastructure can cause severe, invisible non-revenue water losses. Implementing continuous acoustic loggers with AI-driven analytics isolates the precise signatures of subsurface leaks, allowing utilities to target hidden failures early and maximize capital efficiency.

• RTSM And Clinical Drug Dispensation

  A pharma company used Signant Health's RTSM solution in a Phase 2 schizophrenia trial to ensure drug availability, maintain study balance, prevent duplicate allocations, and manage returns and destruction of unused drugs.

• Achieving Excellence In Clinical Research And Quality Management

  Lotus Clinical Research, founded in 2001, leverages regulatory expertise and digitalization to enhance quality, automate processes, and improve compliance in biopharmaceutical clinical trials.