Urtech Medical Writing & Consultancy LLC - Publications

• Enhancing electronic communications between team members by establishing best practices: a communications specialist?s perspective - Electronic media are becoming an integral part of the office environment at companies throughout the world. Electronic mail (e-mail), voice mail, and facsimile machines are readily available and provide an expedient and convenient means of keeping in touch with your company and colleagues from your office, home, or on the road. To fully realize their potential, companies need to agree on the most effective and efficient ways for exchanging information between team members and colleagues. Guidelines are presented.
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• Are you aware of your company?s e-mail policy? - As medical writers and editors, we consistently strive for excellence in our writing and editing of medical and clinical data and information--we familiarize ourselves with standard operating procedures, style guides, regulatory guidances, and document templates; we spell-check our writing; we submit our work to peer review; and we place stringent quality control and quality assurance constraints on our final products. As meticulous as we are with our writing and editing, how often do we apply the same care to e-mail messages we send out from our computers each day?
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• Using cross-functional teams to write combined clinical and statistical research reports: a communication Specialist?s perspective - Increasing economic pressures are forcing the pharmaceutical industry to look for ways to trim costs, improve efficiencies, and reduce the time needed to bring new products to the marketplace. One approach for improving efficiency, and thus reducing the time to bring new products to the marketplace, is through multidisciplinary writing-editing teams. The five basic considerations for developing this team, namely complementary skills, a purpose, goals, a clear working approach, and a sense of mutual commitment, are discussed. Once these basic considerations are dealt with, the cross-functional writing-editing team can have beneficial effects on the combined clinical and statistical research report ranging from better use of available resources to improved colleague morale.
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• The application of metrics to determine the work rate for producing the first draft of the clinical study report: a case study - The final, clinical study report (CSR) of a clinical trial arguably may be the most important aspect of a clinical trial. However, the basis for estimating the time required to prepare a CSR (ie, the work rate) has been based on time-honored estimates. The following metrics analysis, based on recent experience at a large pharmaceutical firm, may provide an objective measure for planning CSR development. The metrics for this analysis come from a small sampling of 10 clinical study reports from 10 medical writers. Word count and elapsed time metrics were collected using features built into MS Word. The statistical relationships of data were checked to verify their significance (their reliability) in making an accurate prediction. Based on the sample data collected and analyzed, meaningful metrics need to be constantly obtained, maintained, and analyzed to produce timely CSRs.