CURELINE HUMAN BIOSPECIMEN ACQUISITION POLICIES
Cureline is a leading global biobank managing HBS projects for development of personalized medicine and biomedical research since 2003. Our services include clinical network management, regulatory affairs, specimen collection, analysis and complete logistics. Our scientific expertise in translational medicine and precision diagnostics development in Oncology and other indication allows Cureline Team a unique position in providing custom biobanking services to global biomedical research community. Cureline’s extensive HBS Biorepository is located in the San Francisco Bay area (California, USA) since its conception in 2003. We have collaborated with hundreds of clinical partners all over the world in order to deliver high quality HBS to our 700+ clients.
Bioethical Policies and Personal Data Protection
Cureline Clinical Network consists of over a hundred major clinical and research centers in the USA, Europe, Asia, Africa and South America. We develop all HBS collection protocols in compliance with the international and local regulations and guidelines. Cureline HBS collection protocols are approved by local IRBs and Ethical Committees. All human materials provided by Cureline are properly consented, de-identified and selected with accurate clinical diagnosis and therapy regimens by certified medical professionals. A standard patient consent form is used for all Standard Collection Protocols. Project-based consent forms are developed for each custom study in collaboration with local IRB/EC and the study sponsor. Standard Operating Procedures (SOPs) are implemented to guard patients' rights and use all donated samples with maximum efficiency.
All provided clinical information is de-identified in compliance with international and local Personal Data Protection laws and regulations (HIPPA in the US). Standard clinical information provided for each case includes age, gender, diagnosis, a pathology report summary and a treatment history. A custom clinical report form (CRF) is developed and implemented in prospective procurement studies. A detailed pathology report from a US-board certified medical pathologist and H&E slides can also be provided upon request.
Our protocols accommodate the quality requirements of most research methods currently used in the drug discovery and development process. Cureline works under the guidelines of the College of American Pathologists (CAP) biorepository certification program and guarantees the quality of all provided human materials and services.
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