Medical writing accompanies a compound from the very first steps of drug development starting in the laboratory trough in vivo testing and toxicology, clinical trials till market release and during the whole lifetime of a drug.

 NeuroScios provides medical writing services for all stages.

  • Study protocols and reports (Phase I-IV)

  • Investigator brochures and annual updates

  • Informed consents

  • Translation of study documents from English to local languages and back

  • Data Safety Monitoring Board (DSMB) manuals 

  • Benefit risk assessment reports

  • Pre-clinical study reports, expert reports and summaries

  • Non-Clinical Safety

  • Periodic safety reports : DSUR

  • Experts opinion

  • Answers to queries from authorities

The quality of these documents plays a critical role in the success of clinical trial submissions and finally the failure of new compounds and devices.

 NeuroScios has more than 30 years of experience in the field. Our team of experts, statisticians, clinical researchers e.g. help to develop the research protocols in clinical studies in order to get the best strategic outcome for either new studies or a final marketing authorization.

All of our medical writers have a background in biology, pharmacology and medicine. We understand the regulatory process in all Central European and Eastern European Countries and the required documentation demanded by Good Clinical Practice, which encompasses the scientific and ethical standards that must be followed in any study involving human subjects.

During the life time of a drug constant work on pharmacovigilance including literature research is necessary. NeuroScios’ own pharmacovigilance department is able to provide safety reporting including case reports and literature Research.