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| Medical Writing
Services has provided an independent
clinical trial report writing service for many years (with writers
generally having over 10 years' experience of this type of writing).
We specialise in working closely with the multidisciplinary team
members within an organisation and respect all internal procedures
and practices in order to ensure accurate data presentation and
interpretation, and strict adherence to regulatory guidelines and
marketing requirements. We are experienced in writing clinical
study reports (including synopses, safety narratives) for all phases
of drug development (phase I, II, III and IV) using the Common
Technical Document (CDT) format, and we aim to support the specific
requirements of clients concerning software systems and the assembly
of data summaries, listings and appendices. Our consistent and
thorough approach to this type of writing is acknowledged by our
clients in terms of the number of repeat contracts we have enjoyed
over the years.
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Large pharmaceutical and clinical research organisations
readily acknowledge the importance of the clinical trial report within
their organisation. This is seen by the pharmaceutical industry’s
significant investment in the training and support of staff to focus
on the quality of this basic document and on its efficient production.
Medical writers are key to this process and recognition of their
role and success in improving the quality and efficiency of clinical
trial report writing is obvious from (i) their growth in numbers
within pharmaceutical organisations, and (ii) their increased attendance
at training programmes aimed at improving the essential skills for
this type of writing. |
| Through the efforts of experienced
medical writers, regulatory
guidelines (e.g. ICH E3, E6, E8, E9 and
E10) have taken
into account the perspectives of writers. Training programmes that
aim to educate, advise and support those writers who specialise in
writing this material are continuously being developed and enhanced
(e.g. by AMWA, EMWA and DIA). |
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