New drugs are the lifeblood of the pharmaceutical industry. Yet strict testing and documentation requirements mean only one in 10 drugs make it to market. Standard Register can play a vital role in documenting the drug development process. By leveraging our expertise in business process management and the latest technologies, we can help you develop a documentation process for clinical trials that is easy and efficient, while satisfying strict FDA requirements.

Clinical Trial Labels Standard Register offers a total solution for producing clinical trial labels. We’ll customize a system of printers, labels, laminators and dispensers to meet your requirements. Moreover, with our proprietary double-blind labels, we’ll help you maintain greater control and confidentiality over trial drugs.

Case Reporting Solutions Each day lost in clinical trials equates to potentially $1.5 million in lost revenues, so the efficiency of the documentation process is essential. By engaging Standard Register well in advance of a trial, we can work with you develop the forms, processes and procedures to optimize efficiency and help you to establish the necessary controls required by the FDA.

Secure Document Solutions With recognized leadership in secure document technologies, Standard Register can help you minimize opportunities for fraud. With a well designed set of features integrated into vital documents, and the proper procedures and system controls in place, we can help you maintain the integrity of trial documentation processes. To learn more about document security, click here.

Related Information & Links
FDA Regulations Relating to Good Clinical Practice and Clinical Trials
www.fda.gov/oc/gcp/regulations.html

Guidance for Industry Computerized Systems Used in Clinical Trials www.fda.gov/ora/compliance_ref/bimo/ffinalcct.htm