Publications by authors named "Thomas M Schindler"

The currently valid Regulation (EU) 536/2014 on clinical trials with medicinal products for human use brings some innovations that are of great importance for patients who participate in clinical trials and patients with a need for innovative therapies. These concern patient protection, especially for vulnerable patient groups, as well as the conditions for further use of data obtained in clinical trials. The introduction of the largely publicly available information system CTIS (Clinical Trials Information System) will significantly improve the transparency of ongoing clinical trials.

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ClinicalTrials.gov was started with the intention to create a consumer-friendly database for patients and others in search of information on clinical trials. However, there is no research on whether the content of ClinicalTrials.

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This article provides Section 2 of the 2017 Edition 2 Medical Writing Competency Model that describes the knowledge, skills, abilities, and behaviors that professional medical writers need in order to perform effectively within the life sciences industry. What a medical writer should know, what they should be able to do, and how they should use this knowledge and these skills to facilitate their primary work function is a focus. Regulatory, publication, and other scientific writing as well as management of writing activities are covered.

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This article provides Section 1 of the 2017 Edition 2 Medical Writing Competency Model that describes the core work functions and associated tasks and activities related to professional medical writing within the life sciences industry. The functions in the Model are scientific communication strategy; document preparation, development, and finalization; document project management; document template, standard, format, and style development and maintenance; outsourcing, alliance partner, and client management; knowledge, skill, ability, and behavior development and sharing; and process improvement. The full Model also includes Section 2, which covers the knowledge, skills, abilities, and behaviors needed for medical writers to be effective in their roles; Section 2 is presented in a companion article.

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Although clinical study reports (CSRs) are one of the central documents in clinical development, little attention has been paid to those features of such reports that determine their overall quality. While the ICH E3 guideline mentions a few quality attributes for CSRs, there are hardly any publications concerned with determining the key quality features of CSRs. This aspect is also often missing in medical writing textbooks.

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