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Clinical Summaries |
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| Medical Writing Services has knowledge and experience of the special requirements of these documents and the working pressures associated with their timely and efficient production. The process of writing, editing and reviewing the full range of higher level documents for marketing authorisation applications is well acknowledged as highly demanding, and we fully understand the need to adhere to regulatory guidelines and timelines specified by the client. We show absolute commitment and by working closely with clinical, biometrics, pharmacokinetics, regulatory, and marketing members of multidisciplinary project teams we achieve efficient, but flexible, working relations that have proved successful in helping our clients to achieve their objectives. | ||
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The challenges of writing clinical summaries and
clinical overviews may be different from those
associated with clinical
study reports, but the same writing skills are highly relevant.
The writer must understand the purpose of each of the different documents.
The documents must give a concise, accurate and highly readable summary
of the trial data, have adequate aids to navigate the reader through
all components and, where necessary offer a clinical interpretation
and judgement that can be readily understood by the audience.
Most pharmaceutical organisations will have clearly defined procedures for creating and assembling the regulatory material that comprises the submission, and effective project management will be fundamental to the speed and efficiency of the submission process. In this context the medical writer will need to show effective communication skills beyond those generally required for medical writing. The writer has a key role to play within a multidisciplinary team and must be skilled at participating in negotiations and discussions that focus on efforts to present the results of drug development studies in an appropriate and rigorous manner. |
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