First-in-human studies of new cancer therapies are the declared specialty here, and the remit starts before the clinic with IND-enabling study guidance and FDA consultations. Regulatory work has included pre-IND, IND, type B and type C meetings with the agency, plus electronic submission operations, product labeling, and gap analyses. Pharmacology support covers sampling strategy design, noncompartmental PK analysis, correlation of exposure with efficacy and adverse event measures, and advice on food effect, gastric pH, and drug-drug interaction studies. Biostatisticians produce statistical analysis plans, Bayesian models, and ADaM and SDTM datasets, while data managers handle database design through to lock, discrepancy management, and medical coding. Trial Master File specialists work to the TMF Reference Model on set-up, inspection readiness, and remediation, and the team will take on rescue of studies already underway. Now in its tenth year, SciQuus also chairs data monitoring and safety review committees.
SciQuus Oncology
SciQuus Oncology is a specialized clinical contract research organization (CRO) dedicated exclusively to managing oncology and hematology clinical trials. Combining therapeutic focus with nimble trial management and clinical development expertise, SciQuus helps biotech companies design and execute efficient protocols that maximize clinical insights and patient safety.
