“IA…. has done such a good job and knows our drug and PK study design well. So, at this point, we would like to transfer responsibility for the CSR to Innovative. Clearly, we have been very satisfied with all the work that Innovative has been doing for us, and we enjoy our working relationship. Kudos to you and the Innovative team for doing such a good job!”
How We Do Medical Writing at Innovative Analytics
IA medical writers are an expert source of knowledge on the scientific, regulatory, and industry requirements of the many types of documents that span clinical development, registration, and beyond. They ensure that key messages are conveyed accurately, consistently, and clearly across all the documents in the clinical drug or device development and registration programs.
Our writers demonstrate an intense attention to detail with respect to scientific content, regulatory guidelines, specialized medical vocabulary, consistency in terminology, key concepts, and grammar and syntax. They understand that attention to detail is a key component to the success of any document and remain steadfast in their quest to produce documents that meet the highest professional standards for quality. Our writers exhibit a commitment to teamwork, including flexible working practices and systems, that allow rapid response to client needs.
All IA produced documents are subject to rigorous control to provide assurance that they are produced in accordance with the protocol, statistical analysis plan (SAP), and regulatory guidelines, as appropriate. The QC process verifies that the data collected during the study is completely, accurately, and consistently reported in the text, tables, figures, and data listings. All QC is documented and available for audit or sponsor review.
Innovative Analytics Works with You
A client had difficulty conveying key messages in their CSR. IA rewrote the CSR with the client.
“I shared your…. report with some of our writers as I think it is a good example of how saying less can actually say much more.”
Overview of Medical Writing Services
Innovative Analytics offers the following Medical Writing Services:
Protocols
Investigator Brochures
Investigational New Drug (IND) Applications
ICH-compliant clinical study reports
Patient narratives
Briefing documents for regulatory meetings
Regulatory submissions in Common Technical Document (CTD) format, including:
Integrated Summary of Efficacy (ISE)
Integrated Summary of Safety (ISS) Safety Update Reports
Responses to regulatory agencies
Advisory Committee Brochures
Manuscripts
