To provide medical writing of the highest quality, our projects are headed by an experienced research person who is focused on tracking a clinical project from its inception to the final study report. Our in-house medical writers are involved in important project communications through every stage to ensure a comprehensive understanding of the study. The final study report is documented along with the inputs of the statistical department.
We have trained scientific and medical professionals with expertise in preparation of all documentation needed throughout the drug development process, in accordance with ICH guidelines and regulations. The highlights are:
-
Protocol development
-
Investigator brochure
-
Informed consent form
-
Clinical study reports
-
Manuscript for publications