Medical Writing

Achieving Compliance with Tailored Medical Writing Solutions.

Inference’s medical writers have years of experience in preparing ICH-compliant study documents from protocols to study reports to integrated documents for regulatory submission.

They have broad experience in using sponsor’s templates and style guides. And if no sponsor template is available Inference will use its own templates.

Our writers work closely with our biostatistics, programming, PK/PD and project management teams to deliver accurate, timely, and cost effective documents to the highest ethical and scientific standards.

Services Include

Protocol

Our writers can prepare a detailed protocol by aligning the objectives, study design and methods by using their extensive understanding of the regulatory framework for presenting such information as well the need for scientific clarity in executing the corresponding clinical trial.

Clinical Study Reports

We have resources with deep experience in preparing CSRs based on the ICH E3 guideline. Our writers work closely with the biostatisticians and clinicians to ensure that the results are presented and interpreted accurately.

Integrated Summary of Safety/Efficacy

We prepare integrated reports such as efficacy, PK and safety summaries as well as overviews and briefing books for submission to regulators.

Other Reports

We also write other reports such as Development Plans, Investigative Brochures, Annual Safety Reports etc.

PARTNER WITH US

When you work with Inference, you gain a trusted partner with the experience, tools, and dedication to support your clinical development goals. Let us simplify the complexities in preparing regulatory documents so you can focus on delivering impactful therapeutic solutions. Connect with the Inference team to discuss further.