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In our cost-restrained healthcare market, clinical performance data of diagnostic tools are an essential ingredient for their market acceptance and commercial succes.

Such data typically come from pre- and post-market clinical studies.

In most larger biotech organizations, a dedicated department (clinical affairs) takes responsibility for the management of pre-market studies (e.g. for registration purposes). 

Because post-market studies (marketing studies) are mostly conducted within the intended use of a diagnostic product, they do not require the level of control typically required for a pre-market study.

The reason for conducting marketing studies is mostly a shared interest between a motivated medical doctor and the manufacturer of the diagnostic tool in question.

Finding the resources for such marketing studies is often a challenge, and here is where CCD comes in to assist.

Always in close collaboration with your organization, CCD can use its experience for generating documentation required for succesful management of the study. 

CCD can help preparing most of the documentation required for the study.

Such as:

• Study protocol
• Informed Consent
• QC report
• Material transfer sheet
• Status reports
• Data sheets
• Final report

Also, CCD can assist in (ghost) writing the scientific report resulting from the study - see Scientific Writing.

Such a report can be a scientific paper to be published in a peer-reviewed paper, a white paper processed into a technical bulletin, etc. 

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For more details or a quotation on clinical study support, please feel free to contact CCD.