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Literature Searches

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It is important to search the literature on a regular basis for information on a company’s drug product that has been published by clinicians and academicians. This need is also valuable in terms of  competitive products. Performing literature searches on a regular basis is known as a current awareness search. Such searching is important for both marketed drugs and those drugs under preclinical and clinical development. Assembling documentation on papers and posters presented at conferences is sometimes the only source of data known for very new experimental products.

Dr. Wells is expert at searching the medical and scientific literature for clients. He has managed current awareness searches for six years. Weekly search results are added to a bibliography citation database (RefWorks, Reference Manager or EndNote) and are reviewed for relevancy. A written summary of the important hits is compiled and sent via e-mail to client key personnel globally. This analysis is performed separately by product and by research program. This approach keeps the company informed at all levels of the organization. Dr. Wells has also created a bibliography online for clients who have not used such a service but have only stored their documents on internal servers. Having a bibliography online allows personnel with granted access the ability to search and obtain results from their own workstation.

Adverse events also need to be searched in the published literature per FDA regulations for both Medical Device and Pharmaceutical companies. Dr. Wells has performed adverse event searches on behalf of Boston Scientific and Medicis (now a Valeant company), as well as several dozen pharmaceutical companies, on a regular basis for eight years. In addition to searching, Dr. Wells has experience in writing the annual report that is required by the FDA for medical device products, having prepared this type of report annually for the last four years. Literature searching is a specialty and Dr. Wells has a knack for finding articles, papers and hits that are not in the mainstream literature.

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