Clinical Writing

Service Details

Clinical writing involve a part of our services with a dedicated team, who are Ph.D.s and M.D.s, to write up the results of several phase II and phase III studies that were to be submitted as part of the regulatory process for approval of the product. They are Specifically involved in writing up the results of the efficacy analysis and the related discussion. IGRS Team shall support in Clinical writing, especially for regulatory reports, follows strict guidelines set up by organizations such as the U.S. Food and Drug Administration and the International Conference on Harmonisation. The whole clinical process must follow Good Clinical Practice guidelines that, in the case of clinical report writing, demand extreme care in presenting the data objectively and accurately. We at IGRS can support for a biotech company, large pharmaceutical company for protocol design, recruitment of investigators and subjects, investigator meetings, the clinical monitoring process, data management, clinical research organizations, adverse event reporting, and so on. Of course, in any biotech company, there are also lots of opportunities to be involved in the preclinical basic science that is necessary to develop the therapeutic products.