Product Safety/Pharmacovigilance

WHITE PAPERS AND CASE STUDIES

• Compliance Auditing: Diving Into Common Critical Findings

  Review critical findings in compliance audits, highlighting frequent issues, their impact on operations, and steps companies can take to improve regulatory compliance.

• Injection Site Reaction Screening Methodology

  Optimize drug formulations for solubility at physiological pH to reduce injection site reactions, enable high-concentration dosing, and enhance patient comfort and compliance.

• 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.

• Improving Pre-Clinical Study Efficiency With mRNA-LNP Technology

  Uncover how Repair Biotechnologies, in collaboration with Vernal Biosciences, helped to pave the way for the next generation of breakthrough treatments for cholesterol and aging-related diseases.

• Navigating The FDA's Drug Supply Chain Security Act

  Explore the transformative impact of the DSCSA on the pharmaceutical industry, which ensures stringent standards, prevents counterfeit drugs, and enhances traceability for both large corporations and small manufacturers.

• Optimize Startup And Payment Processes

  Delve deep into the collaborative journey where global CRO Linical was able to revolutionize its financial lifecycle of clinical trials—from initial budgeting to seamless site payments.

• RTSM: Randomization And Cohort Management, IP Inventory Management

  Signant’s SmartSignals® RTSM solution helped an innovative biopharmaceutical company secure an FDA Orphan Drug designation for its cardiomyopathy drug.

• Using IR Spectroscopy For Counterfeit Drug Detection

  Spectroscopy technology using diamond-turned mirrors, beamsplitters, and other optical components is especially helpful for the detection of harmful chemical compounds that may be found in counterfeit opioids and other pharmaceutical drugs.

• The Benefits Of End-To-End Formulation And Fill/Finish Of Biologics

  Proper formulation development has a huge impact on whether a technology transfer to clinical phase fill/finish is successful. Review the challenges of transitioning a promising drug candidate.

• Accelerate Development Of Enabled Formulations For Poorly Soluble Drugs

  Explore how a platform integrating drug substance, drug product, and clinical testing within a single organization accelerates development and reduces costs, helping deliver positive outcomes earlier.

• Match Your Development And Manufacturing Path To Your IND Milestones

  The drug development journey is long, expensive, resource-straining, and risky. Discover how to maximize the value of early-phase material and match your development path to your IND milestones.

• Navigating The Evolving Landscape Of Immunotherapy in Oncology

  Immunotherapy is revolutionizing oncology, enhancing patient outcomes through targeted treatments. This evolving landscape includes checkpoint inhibitors, and personalized medicine, shaping the future of cancer care.