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A clinical study report provides a clinical and statistical description, presentations and analyses of the completed study. The clinical study report should include an explanation of the critical design features, the plan, methods and conduct of the study, individual patient data and details of analytical methods.
CodLad has a unique approach to the analysis and reporting of clinical trials.
CodLad’s Programming team provide expert CDISC services as well as the development of dataset specifications. If you have a submission approaching with legacy format datasets, CodLad can upgrade these to CDISC compliant datasets (SDTM and ADaM). CodLad’s senior team has extensive experience with regulatory bodies and participate in regular regulatory interactions.
We can provide all the necessary associated documentation that a submission to the FDA will require (or other global regulators), including annotated CRFs, define.xml and/or define.pdf and a regulatory reviewer’s guide. If you are planning an integrated summary of efficacy and safety, we can help put together CDISC compliant datasets. We can also provide advice on the format of the data that will be acceptable to global regulatory bodies.
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