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Study protocols |
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| Medical Writing Services... | ||
| works with the client’s clinical research, biometrics, and regulatory team members to ensure protocols, and any subsequent amendments, are written according to relevant guidelines and to the required standards of presentation and readability. We pay strict attention to the entire content and structure of the protocol including the correct inclusion of appendices, overall study design, and quality control issues. Our aim is that users of protocols (including writers themselves, who use protocols when writing clinical trial reports) will find them easy to read and understand. | ||
| Several formal
guidelines (e.g. ICH E3, E6, E8, E9
and E10) govern the style and content of this key document and the
conduct of a trial in the drug development process. Most large organisations
have developed templates and adopted clearly defined procedures to
help in the design and writing of their study protocols. Nevertheless,
many protocols are still written without the skills of a medical
writer. As a result those who use the protocols can experience difficulties
in trying to make sense of ambiguous and poorly presented text. Moreover,
medical writers are often expected to write a clinical study report
from material that includes a poorly written protocol. This inefficiency
can be avoided by employing a medical writer for all stages of protocol
preparation. |
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