Clinical study report
Smooth Drug Development provides services throughout medical writing process including clinical study report or CSR preparation.
CSR is an "integrated" full report of an individual clinical study and statistical analyses of data derived from a clinical trial.
Clinical Study Report approval by Regulatory bodies very much depends on the completeness, accuracy, consistency of data, compliance of statistical methods to the Study Protocol, explanation of deviations from the Study Protocol.
Our medical writers have extensive experience in clinical studies of phase I-IV, therapeutic equivalence trials, bioequivalence trials, biosimilar and novel drug trials.
Since 2011 our company have prepared more than 70 clinical study reports. We are proud that our company clinical study reports have never been rejected by the regulatory bodies.
Our medical writers work in accordance with Russian and international standards, GCP, EMA, FDA requirements and company SOPs.
When interpreting clinical study results we invite key opinion leaders in the relevant indication. Clinical Study Reports can be prepared in Russian or English.
Clinical Study Reports for the studies conducted in Russia are prepared in accordance with the requirements of Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation.
Our medical writers are trained regularly and attend seminars conducted by SCEEMP, which allows us to take into consideration latest regulatory requirements.
Our specialists prepare study reports in accordance with ICH E3 "Structure and Content of Clinical Study Reports" requirements to structure, format and content.