Clinical Research Services
The Clinical Research Program (CRP) bridges innovative laboratory discoveries and clinical applications to support interdisciplinary translational research initiatives. Using human samples and epidemiological information, the CRP investigates etiology and progression of disease in the body. In support of these investigations, ILS offers a wide range of services from laboratory to study management, data analysis and management, software design, and epidemiological support.
Clinical Study/Trial Management
Project management
- Proactive approach to all management tasks
- Honest and open communication channels
- Dedicated ‘one point of contact ‘ manager for all aspects of study
- Regular meetings with sponsor
- Close tracking of study deliverables
- Periodical update reports to sponsor
- On time deliverables to meet and exceed expectations
Study Set-up
- Investigator meeting management
- Study site identification and selection
- Strategic patient recruitment plan
- Central Laboratories selection and management
- Central IRBs selection and management
- Study protocol and ICF preparation
- Preparation of CRFs, study questioners, and other study forms
- Study site regulatory notebook preparation
Clinical monitoring plan
- Study monitoring
- Regulatory document collection and review
- Site contract administration
- Site personnel protocol training
- Pre-study, Study initiation, interim and closeout visits
- Study supplies
- Drug accountability
- Data query resolution
Study Data Management
- Database Design and Maintenance
- Data Analysis using SAS and Other Programs
- Design and Implementation of Software for Medical Image Analysis
Additional Study/Trial services
- Translational Analyses
- Histology/Pathology
- Molecular Characterizations and Analysis
- Genetic Characterizations and Analysis
- Collection of Pathology Tissue at Surgeries
- Coordination and Processing of Blood and Urine Samples from Hospitals
- Storage, Tracking and Archiving of Tissue Samples for registries and repositories
- Safe Handling and Transport of Samples Using Appropriate Chain-of-Custody
- Liquid Nitrogen Storage and -80°C Biofreezers with 24-hour Monitoring
Clinical Study Site
Experience and capabilities to serve as site for clinical registry/epidemiological studies
- Patient recruitment and Informed consent process
- Experience in recruitment at public events for the registry/epidemiological studies
- On site and Mobile Phlebotomy capabilities
- Qualified and Certified staff
- Quality Control/Quality Assurance Guideline Adherence
Lead Scientist
Enrikas Vainorius, MD
Phone: 919 281-1110 Ext. 710
Email: (JavaScript must be enabled to view this email address)
As the Clinical Program Manager. Dr. Vainorius is responsible for activities such as staffing, leading the program’s vision, success and growth. Dr. Vainorius interacts with commercial and government clients in clinical program business development activities to secure new and maintain existing contracts. He is responsible for extending the program’s capabilities, meeting current deliverables, and management of the day-to-day aspects of clinical research studies/projects currently conducted by ILS. Dr. Vainorius has 10 years of biomedical and clinical research experience, obtained while working in different organizations, including hospitals, the pharmaceutical industry, and academia. His experience in biomedical research includes pre-clinical _in-vivo _studies of cardiovascular diseases ranging from disease physiology to development of novel cellular therapies and diagnostic methods based on adult stem cells. During his work in the pharmaceutical industry, Dr. Vainorius acquired expertise in clinical trial monitoring and management, including clinical trial design and implementation, data analysis, regulatory/procedural compliance for Food and Drug Administration and other regulatory entities, study site recruitment, and study fiscal management. He received his MD at Kaunas Medical University (Lithuania, EU).