Based on the FDA recommendations, pharmaceutical and biotechnology companies are incorporating biomarker development into the drug R&D process. Protocols for targeted medicines clinical trials now include  biomarker assays development in order to identify groups of patients that are most likely to respond to a particular drug.  Thus, biospecimen collection, processing and preservation have become crucial components of clinical trials conduct and management.   

Building on expertise in biospecimen procurement and conduct of clinical trials, Cureline team has developed a portfolio of services in biospecimen management for biomarker discovery and diagnostic tests development, including:

•    Development of biospecimen collection protocols in collaboration with the study sponsor

•    Conduct of FREE biospecimen collection feasibility investigation with major clinical centers

•    Consulting with leading clinical experts on patient inclusion / exclusion criteria 

•    Preparation of regulatory documents and submission packages for the EC/IRB approval

•    Clinical site selection, qualification, and initiation of the biospecimen collection protocol

•    Clinical staff training and support in patient recruitment (including slow protocol auditing)

•    Regular site visits and monitoring

•    Sample shipping, storage and research evaluation logistics

We also specialize in diagnostics biospecimen collection for the diagnostic test large-scale production.


Clinical Information:

All human materials provided by Cureline are properly consented, de-identified, and selected with accurate clinical diagnosis and therapy regimen by certified medical professionals.  Project-based case report forms (CRF) are developed and implemented for each study.  A detailed pathology report from a US-board certified medical pathologist and H&E slides are provided for each case.

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Bioethical Policies

Cureline collaborates with the major clinical and research centers in Europe, Asia, and the USA on biospecimen collection projects.  Our team develops biospecimen collection protocols that are approved by local IRB and Ethical Committees and that comply with international and local regulations and guidelines.  

Cureline is committed to ensuring that research biospecimen collection does not interfere with the patient's well-being, and that a proper consent form is developed for each study in collaboration with clinical sites and the study sponsor.  Standard Operating Procedures (SOPs) are implemented to guard patient’s rights and to use the biosamples with maximum efficiency.