Product Overview
Kit Production/Clinical Trial Support
We can provide the supportive services needed for your clinical trial, leaving you free to focus on patients and treatment issues. Our clinical trial support services include:
Design and Set-Up, including creating the study manual and presenting at Investigator’s meetings
IVRS/IWRS Services, collaboration with our sister company Cenduit
HIPAA Compliance, IRB review and assistance with patient consent forms
Collection Kits to standardize specimen collection and transport
Randomization and Blinding of study products
Laboratory Processing, including DNA/RNA extraction and amplification
Labeling and Distribution of Drug Products and Clinical Agents, including biopharmaceutical agents (in cryogenic shippers) and vaccines (in validated shippers with on-board temperature monitors) around the world
Storage and Handling of Clinical Agents, in compliance with 21 CFR 211.142 and Pharmacy Regulations for the State of Maryland
Financial Flexibility, through monthly billing
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