Originally Published MX September/October 2003

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

Clinical study design, management, and analysis comprise a variety of necessary tasks and functions. Company executives may choose to develop in-house capabilities for performing all of them, or may opt to outsource some or most services to firms offering specialized expertise. The key functions involved in conducting a complete clinical development program follow; those marked with an asterisk are commonly outsourced by early-stage medical device companies.

o Clinical trial design and protocol preparation.*
o Case report form development and production.*
o Informed consent design.
o Standard operating procedure (SOP) development.
o Investigational-site/investigator selection.
o Ethics committee approval.
o Investigational-site initiation.*
o Dispatching of devices.
o Investigators' meeting coordination.
o Investigational-site monitoring.*
o Good clinical practice (GCP) compliance monitoring.*
o Data management (including collection, entry, and cleaning).*
o Data analysis.*
o Adverse-event tracking.
o Report preparation.