We are dedicated to providing specialized laboratory testing to support clinical trials and investigations in the field of infectious diseases.
A Range of Flexible Support
The Laboratory for Specialized Clinical Studies (LSCS) has a 20-year history of providing support for clinical studies and vaccine trial services. Our experience ranges from partnering with major pharmaceutical companies to providing personal attention to individual investigators working on smaller scale projects.
A sampling of the LSCS’s pediatric and adult clinical study experience includes rotavirus, influenza, cytomegalovirus (CMV), human calicivirus (HuCV) and other enteric and respiratory pathogens.
Providing Clinical Trial Services
The LSCS conducts high-quality infectious disease and immunological testing to support clinical trials. We also support the Cincinnati Children’s Hospital Medical Center as one of eight NIH-funded Vaccine Testing and Evaluation Units. The laboratory capabilities include development and validation of customized assays and integration of customized statistical software. All assays are conducted within the guidelines specified by College of American Pathologists (CAP) and quality laboratory standards.
These cost-effective assays are performed at a high volume with rapid turnaround, utilizing state-of-the-art calibrated and controlled equipment. Accurate and precise data are routinely generated for hundreds of test samples. Other features of our lab include:
• Experience with vaccine clinical trials phases I-IV
• All procedures conducted in a BL2 environment
• High throughput and quick turnaround
• CAP and CLIA accredited
• Compliant with GLP guidelines
• Fully auditable data to support submission of new or modified vaccines and biologics
• Laboratory services are supported by a laboratory quality assurance officer and an independent Office of Research Compliance and Regulatory Affairs.