Safety and Pharmacovigilance

It’s More than Formatting Narratives

We understand the data!

We recognize that health authority reviewers thoroughly evaluate clinical safety narratives. The WI writers have worked on tens of thousands of narratives. Our understanding of the data is key to providing the document that best meets your needs. Whether you need a streamlined narrative linking to a CIOMS report or an in-depth narrative to reside in Section 14 of a clinical study report, the writers at WI have the experience and expertise to provide those documents for you.

We can address your pre- and post-market approval pharmacovigilance needs. We understand the activities that are required by health authorities globally to assess and communicate the evolving safety and benefit/risk profile of developing and approved products. WI writers can work with your team to craft DSURs for developing products and PBRERs/PADERs/PSURs for approved products according to ICH and local guidelines. We are also experienced in creating and updating REMS and REMS assessment reports for FDA and Risk Management Plans for the EMA and other regulatory bodies.

We have MD reviewers who can provide detailed comments and guidance. Our QC reviewers are reviewing for consistency with the data and completeness and compliance of the document, based on the available source documentation. Our teams will work with you to create, edit, and review your safety and pharmacovigilance documents. These documents will look great and we will ensure that their content is accurate, reliable, compliant, and readable.