Since the FDA and EMA released guidance on risk-based monitoring in 2013, implementation of the laid-out principles has matured into a RBQM approach. Widespread adoption of RBQM has been slow due to the persistent belief that trial quality can only be achieved with a high degree of source data verification (SDV) and recurring on-site monitoring visits.

Toxicol Pathol 2021.49:569-580 -- In all toxicology studies, the differentiation of microscopic findings induced by a test article from the spontaneous background findings that may occur in the tissues of a given species is critical.

Inspiring Science Scientific Acumen Rich Medical Expertise Committed Team of Therapeutic Area Specialists Patient-Centric Solutions Product Development Consulting Group Patient Intelligence Database Enterprise-Wide Excellence Biomarker Center of Excellence Integrated Services Cell and Gene Therapy

Nonalcoholic fatty liver disease (NAFLD) is defined by the accumulation of lipids in hepatocytes, in the absence of significant alcohol intake, viral infection, or other etiologies of fatty liver disease.

Equal Access to Innovative Medicines across Europe

SETAC-EU 2021 -- Honeybee toxicity studies are an essential requirement in today's regulatory climate. In particular, field and semi-field trials are very high value Terrestrial Ecotoxicology study types that continue to be in ever-increasing demand from global customers.

Benefit of using the DCT Investigator Network

This white paper provides an overview of CDx, compares development and regulatory paths and discusses the challenges faced in commercialization, utilization and uptake of these tests.

CYTO 2021 -- With the progress in drug development for cancer immunotherapy, a comprehensive evaluation and scoring of solid tumors resected from patients will allow for optimization and selection of most beneficial therapies and provide insights for personalized medicine.

CYTO 2021 -- Regulatory T cells (Treg) represent a distinct subpopulation of T cells involved in the modulation of immune responses to pathogens, allergens, and auto-antigens.1,2 They suppress inflammation by inhibiting both T cell proliferation and cytokine production.