High-Quality Medical Writing to Support Your Studies
Your clinical trial documents tell the true story of your study. Our proficient team of medical writers has the experience and expertise to deliver clear, accurate, regulatory-compliant materials that fully support your clinical trial.
What’s more, when you combine a superior team with a streamlined process, you receive a cost-effective solution that saves your study time. Our process allows writers to maximize efficiency by easily accessing information and collaborating with key stakeholders and project team members. Once your materials have been expertly crafted, our strict clinical, medical and statistical review process ensures you receive ICH and GCP-compliant materials on deadline.
The end result is high-quality study documents that accurately, efficiently and economically represent everything your clinical trial has to offer.
Focus on Quality & Delivery
Meticulous Study Materials Delivered On Time
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.
Medical Writing Services That Create Successful Studies
We create a wide variety of documents to cover every aspect of your clinical trial from Phase I to IV and everything in between:
Clinical trial protocols
Patient information leaflets
Standard operating procedures
Safety update reports
Interim and fully integrated final clinical study reports acording to ICH E3 and eCTD
Subject information sheets and consent forms, including local language ICFs (prepared and reviewed by the relevant country)
Abstracts, manuscripts and posters
Medical and scientific publications for peer-reviewed journals
NDA/sNDA, MAA, PMA, 510(k) and CTD technical summaries
IND summary sections and special reports
Pre- and post-approval aggregate safety reports
Serious adverse event narratives
Looking for quality and timely delivery in your Medical Writing efforts?
Our team consistently delivers. Talk with our team today.