The growing field of cellular and gene therapy is a highly regulated area. Let Comprehensive Cell Solutions (CCS) help you navigate through the complexities.
Leaders in the areas of transfusion medicine, cellular therapy, immunology, and epidemiology, our team has extensive regulatory experience, having successfully designed, reviewed, and overseen hundreds of research projects and preclinical and clinical studies. We are also experts in providing consultation on FDA requirements and filings, certification, and 510(K) applications, as well as advising on and directing technical performance, improvements, and adaptations to meet and exceed FDA certification requirements.
Clinical Trials Advisory & Management
From start to finish, CCS can support your clinical trial needs. We can help with IND submissions and the design and implementation of early-stage trials. For organizations further along in planning and clinical development, we are also well equipped to review protocols for scientific accuracy, feasibility, and design in order to maximize trial viability and validity.
We leverage our extensive expertise in medical services, quality assurance, research, and research oversight to ensure clinical trials are successfully implemented. Through our affiliation with the New York Blood Center Enterprises (NYBCe), we also leverage our vast infrastructure, which includes our blood operations, translational center, medical programs and services, and a growing network of collaborating blood and research centers across the country. These resources and core competencies allow us to execute projects and studies with precision, exceptional quality, and open interaction with our biopharmaceutical and academic partners.
Subject Recruitment
For many years, our highly trained nurses and other key personnel have been involved in subject recruitment. Through CCS’s affiliation with the NYBCe, our vast donor network grants us access to hundreds of thousands of normal, healthy donors who can be utilized as the source of subject recruitment for studies. In addition, we have access to individuals with positive test results for certain infectious diseases or other specific qualities that can be used for study recruitment.
Institutional Review Board (IRB)
The Institutional Review Board (IRB) mission is to protect human subjects from physical or psychological harm, which they accomplish by reviewing research protocols and related materials. The protocol review assesses the ethics of research and methods, promotes fully informed and voluntary participation by prospective subjects capable of making such choices and seeks to maximize the safety of subjects.
Our IRB Services include:
- Timely administrative “pre-review” of the submission to determine level of review required, full-board, expedited, or exempt
- Full-board reviews are performed monthly, with the exception of the month of August
- Board findings and required modifications, if any, are reported to investigator
- Annual Reviews
- Amendment Reviews
- NYBCe [CCS?] IRB may act as the IRB on behalf of other institutions
- NYBCe IRB may act as the designated Central IRB for multi-site studies
- IRBNet, an electronic submission and research management program that enables easy submissions and notifications
Consulting
Our experienced leaders are available to consult on a wide range of customer needs.