Sponsorship Services

The SUNY Upstate Sponsorship Office offers clients the
opportunity to sponsor FDA regulated clinical trials. Upstate can provide all
capabilities to be the regulatory sponsor or can supplement your internal
capabilities. In conjunction with preferred partners, we offer Pre-IND and IND
preparation, clinical protocol development, IND reporting, medical writing,
database development, safety reporting, pharmacovigilance, TMF maintenance,
regulatory strategy, statistical analysis and TLF development, SDTM and ADaM
programming, and electronic submission. Combining our clinical research team,
recruiting staff, laboratory services and quality oversight within the
Institute for Global Health, Upstate can be the source for all your clinical
trial needs.

Quality Affairs

The Institute of Global Heath and Translational Science
takes full advantage of the Quality Affairs office within SUNY
Upstate.   This office provides
expertise in the areas of GxP to Upstate faculty and departments,
including the following:

• Quality Management System: Implementation of systems that are compliant to GCP and GLP regulations.
• Training on GCP and GLP, setting up training procedures and tracking systems
• Assess Documentation: Proper documentation is key in any clinical study. Regulatory bodies and sponsors often ask first to see documentation as the first step in any audit.  
• Assistance with external audits: Sponsors and regulatory bodies can audit studies at any time. Quality affairs can help navigate those audits. Pre-audit preparation, planning and coaching is also available. 
• Navigate corrective and preventative actions (CAPA) are a key part of any quality management system
• Help with risk assessments using a risk-based approach to policies and procedures is expected in today’s regulatory environment.
• Evaluate and help with the implementation of GCP/GLP activities

Clinical Sample Processing and Analytical Research Support Laboratory

Laboratory services for the Institute are provided through two components: Sample Processing and Analytical Research. Working closely with the Clinical Research team, all research blood samples from human clinical trials are processed in a GCP-compliant laboratory that maintains audit readiness through training, following SOPs, maintaining equipment, and adhering to Good Documentation Practices. Serum, plasma, and PBMCs are collected, aliquoted, and placed in cold storage units with 24/7 monitoring and alarm notification. Samples are shipped and/or transferred internally for analysis per study requirements. The analytical services available include real-time RT-PCR (quantitative and qualitative), ELISA, flow cytometry, detection of viral neutralizing antibody (Dengue, Zika), cell culturing, virus propagation (Dengue, Zika), plaque assay, and cytokine array. Additional capabilities that are available through the Upstate Core facilities include proteomics, LC-MS, transcriptnomics, RNAseq, multi-color flow cytometry and cell sorting.