Based on the FDA recommendations, pharmaceutical and biotechnology companies are now 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, the 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.
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 also provided for each case.
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.
- Clinical Trial Samples Management Clinical Trial Samples Management
- Consulting Services Cureline offers expert consultancy services to improve tissue collection efforts that are a part of your clinical trial
- Human Tissues for Research Drug discovery companies focused on molecular targeted therapies face challenges in building state-of-the-art programs geared towards the identification of specific molecules (lipids, proteins, enzymes, etc.) which may play critical roles in governing human diseases, such as cancer, diabetes, asthma and rheumatoid arthritis thereby providing rational molecular targets for therapeutic intervention.
- Cureline Partners Dear Clients, Cureline's team works closely with PIs and PMs on developing and implementing biospecimen acquisition protocols. Our File Sharing System is now available online for your convenience. You may check there your project status, biospecimens collection progress and download collection protocols, patient informed consent and other information.
- Cureline Alliances Cureline Alliances
- Publications Cureline Publications
- The Cancer Genome Atlas The Cancer Genome Atlas (TCGA)