An effectively designed document management system is vital to any organization. At Paradigm we can structure a customized Document Control Department that will allow your staff to readily locate and share paper and/or electronic documents.
- Develop an intuitive naming convention for various document types
- Develop a filing taxonomy for your paper documents
- Develop an electronic folder taxonomy for electronic document
- Develop a change management process for document approval
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In the Biopharmaceutical industry the Clinical Research Associates have, what can be, the daunting task of tracking and maintaining essential documents for clinical trials. These documents have a significant importance and it is vital to the Clinical Development Department have the confidence to submit these documents to Document Control and know that they will be readily retrievable. At Paradigm Consulting we understand this issue and can develop a filing taxonomy for the Clinical Operations Department site files and master files documents that will facilitate speedy retrieval of essential documents, greatly decrease the amount of time the CRA's spend on tracking documents and result in increased confidence in Document Control Department 's document management abilities.
We have also developed a training curriculum designed to familiarize your Document Control staff with the phases of a clinical trial and the essential documents generated during the trail process so decrease the occurrence of misfiled documents. Our training covers ICH guidelines and the relevant portions of the Code of Federal Regulations.
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Clinical Trial Essential Document Training for your Document Control Staff
Providing your staff with a better understanding of the clinical trial process will result in a decrease in filing errors
and will allow for more efficient document retrieval on a day-to-day basis; your organization succeed in achieving a smooth flow of routine information between departments.
To review the training curriculum, take a look here:
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