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RISK MANAGEMENT

The need to evaluate risks related to the use of new pharmaceuticals and medical devices is well understood by the sponsors of clinical studies. However, there are also risks associated with the conduct of the studies themselves which can jeopardise the success of the study, regardless of the safety aspects of the product.

Examples of these risks include:

• A Competent Authority may raise questions about a clinical study protocol, which can delay the start of a study.
• A sponsor may not fully understand local requirements and fail to submit the documents needed for study approval, again resulting in delay.
• A clinical investigator may use the device in a manner that is inconsistent with the instructions for use supplied by the sponsor, compromising the acceptability of the study results.
• A change during the clinical study may jeopardise the ability of the study to support a clinical safety result, or achieve device CE marking.
• A clinical monitor may fail to report identifiable protocol deviations to the sponsor.
• The data management process may be poorly controlled, resulting in unreliable study data.
• Adverse events may not be reported to the sponsor or Competent Authority within the required timescales, resulting in Competent Authority intervention.

Donawa Lifescience Consulting understands that risk management concepts and principles extend far beyond device-related risks. As such, we can help develop a systematic and comprehensive approach to management of clinical study risks, so that undue delays and unplanned costs are avoided.

Please contact us for further information or assistance.