Trial Reports-Items

ISSUES INVOLVED IN REPORTING CLINICAL TRIALS

Running the clinical trial is your core expertise. Once completed, you have an extensive set of raw data that should be analysed to take out the key results, to be further converted to a coherent and logical presentation required from a professional CSR.

However, these last steps might prove to be the true bottleneck for the completion of an otherwise successful trial. Thus, the completion of the CSR is delayed, perhaps because of the limited resources of your in-house writing staff and statistical expertise. Another important reason for a delay in getting approval to your new drug can be insufficient, inaccurate or slow reporting of the results of your clinical trial.

Such obstacles in completing the requested CSR should not be beyond the control of your company any longer. In both cases, the optimal solution would be to let a single team to complete the statistical analysis and the writing. The major advantage of this approach is that the results and their presentation (tables, graphs, figures) are in line with the report text, making it concise, clear and informative.

This is because we at SMW Consultants are ready to give you any assistance that you might need in making your CSRs highly professional documents. The core expertise of SMW Consultants is the medical writing, in all its different formats, from simple congress abstracts to regular research reports, international textbooks, and everything in between.

Asking SMW Consultants to write your CSR is the best warranty that the report is fully compliant with the ICH guidelines. In addition, several other issues are of importance in making CSRs professional documents. :

CSR prepared in a client-specified format

Having probably run several trials before, you certainly have a specific format that your company has adopted for all its CSRs. Just sending us a copy of any such previous document, we ensure that you will get the new ones prepared exactly in the same format.

CSR in an SMW-specified format

In case you do not have a preferred format of your own, you might opt selecting an SMW-specified format for your CSR that you order from us. Also that is perfectly OK, and you can select among several professional-style formats used for these documents.

CSR is clear and concise

Clarity is among the most important properties of CSR. The text must be concise, including all the facts, documented by statistics. With the experience of over 1.000 personal scientific communications published until now, writing these reports is among the core expertise of SMW Consultants.

CSR contents

Apart from the mode of presentation, contents of CSR is crucial. The results must be presented in tables, graphs and images, in a logical sequence including all the relevant results of the trials. This is not different from the commonly adopted practice in writing good original scientific reports, which is a daily routine in research projects involved by our CEO.

CSR is an honest document

Being a report of a clinical trial on human subjects, CSR has an absolute requirement of being an honest document. Most importantly, this entails that any unexpected findings during the trial are properly identified.

Accurate and timely completion of the CSR is clearly the key to avoid delays in the approval process of your new drug. SMW Consultants are prepared to offer you assistance in making these reports on time and fully compliant with the requested guidelines.