Clinical Regulatory Writing

The number and complexity of clinical studies is increasing year-by-year. Today, we’re helping our clients meet an unprecedented demand for Medical Writing services.
Our Flexible Sourcing Model

We have successfully delivered thousands of regulatory documents to clients over the last decade

We pride ourselves on providing a high-quality service through flexible sourcing models. Clients can fully outsource particular document types, engage us for specific programs or use us to manage peaks in workload.

In return we deliver the work through on-shore, off-shore or a blended model depending on client preference and project requirements.

We also offer a standalone document quality control (QC) service so that clients can be confident of document quality regardless of whether these have been developed by in-house writers or by a medical writing vendor.

Clinical Writing

Flexible and scalable adverse event narrative writing solutions.

Adverse event narratives for inclusion in Clinical Study Reports are a necessary, but resource-intensive, activity.

Kinapse has delivered hundreds of narratives on time, often working on the critical path for key regulatory submissions. Our flexible sourcing models allow our clients to cost-effectively deal with the large peaks in medical writing workload narratives bring.

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Explore more of our services

It is in the clinical space that we do some of our best work and we are proud of the strength, depth and capability of our team to deliver successful clinical advancements.
View all of our services and see how they fit into the drug development life cycle.

Clinical Trial Disclosure

You will be working with one of the most experienced Clinical disclosure teams in the industry, from statisticians to project managers with hundreds of years of combined experience under our belt.

Market Access

Using our industry-leading market access and HEOR services, we help our clients demonstrate the value of the new drugs they have developed.