Originally Published MX
September/October 2003
BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT
Elements of a Clinical Development Program|
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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.
Clinical trial design and protocol preparation.*
Case report form development and production.*
Informed consent design.
Standard operating procedure (SOP) development.
Investigational-site/investigator selection.
Ethics committee approval.
Investigational-site initiation.*
Dispatching of devices.
Investigators meeting coordination.
Investigational-site monitoring.*
Good clinical practice (GCP) compliance monitoring.*
Data management (including collection, entry, and cleaning).*
Data analysis.*
Adverse-event tracking.
Report preparation.
Electronic-document management.
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