Because studies require a high volume of high-quality, impeccable materials, every word and every minute counts. Our stringent and streamlined process ensures you receive exceptional documents to support your clinical trial in the most efficient way possible.
From the beginning, we incorporate standardized guidance into our templates from TransCelerate Biopharma, a nonprofit organization providing solutions to drive more effective delivery of new medicines. Because the FDA and other regulatory groups are already familiar with these templates, it helps to streamline and shorten your review time.
Our knowledge of all GCP and ICH guidelines ensures your documents are drafted in adherence with all regulatory standards. From there, our quality control process includes statistician and peer medical reviews during every round and with every draft to confirm correct interpretations have been reached. By implementing measures to ensure we do all this as quickly as possible, you receive study documents that are accurate, on time and within your budget.
