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European Pharmaceutical Contractor

Standard of Excellence

Study designs have a significant impact on the cost, time and complexity of conveying information throughout the clinical trial lifecycle. Opportunities to improve governance and increase operational efficiencies are limited when protocol authoring practices are a non-standard, ad hoc set of authoring and reviewing activities with little visibility across the organisation. Transforming protocol development to a standards-based, measurable and controlled process can enable significant improvement of clinical trial programmes. Such a standardised approach arms the organisation with visibility into the once opaque protocol development process. It also delivers considerable returns as protocol content is consumed by upstream planning activities such as the study plan and concept, and feeds downstream clinical systems such as electronic data capture (EDC).

There is no doubt that the study protocol is the ‘heart’ of a clinical research study. It is the controlled plan and source for the majority of study information that is collected, used and referenced throughout the lifecycle of the study. There is also little argument against the fact that a standardised, measurable and repeatable process can improve operational performance by improving efficiencies and effectiveness across the clinical trial lifecycle.

The industry is achieving a consensus of standards among the various study protocol components and technologies through organisations such as the Clinical Data Interchange Standards Consortium (CDISC), Health Level 7 (HL7), and the American National Standards Institute Healthcare Information Technology Standards Panel (ANSI HITSP). Proactive organisations are currently in the process of building the infrastructure and standardising their processes to take full advantage of the industry efforts as they evolve.


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David Gemzik brings more than 12 years of experience in software development and services to his role as Vice President of Implementation Services at Medidata Solutions. David specialises in the design and implementation of clinical research enterprise systems and processes leveraging industry standards, technologies and interoperability.
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David Gemzik
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