Medical Writing: A Collaborative Approach

Led by a team of seasoned professionals, our Australia-based, doctorate-trained medical writers bring an average of over 20 years of pre-clinical and clinical research experience to the table, ensuring a deep understanding of regulatory standards and scientific intricacies.

A Team Approach To Medical Writing

We believe in the power of teamwork to drive success in clinical research. Our Medical writing team collaborates seamlessly with other key stakeholders, including biostatisticians and pharmacokinetics experts, to provide integrated solutions tailored to the unique needs of each project.

Compliance With Regulatory Guidelines

At Avance Clinical, we strictly adhere to regulatory guidelines to ensure the integrity and reliability of our clinical research. Our protocols are developed in compliance with the Guideline for Good Clinical Practice ICH E6 (R2), and our Clinical Study Reports (CSRs) are prepared according to the Guideline for Structure and Content of Clinical Study Reports ICH E3. Working in collaboration with our biostatisticians and pharmacokinetics experts, we uphold the highest standards of quality and compliance in every document we produce.

Empowering Your Clinical Success Through Expert Medical Writing Solutions

Partnering with Avance Clinical means accessing a dedicated team of medical writers who are passionate about accelerating the approval process, minimizing delays, and ultimately driving success for your clinical research program.
Join forces with Avance Clinical’s Medical writing team and experience the difference of a collaborative, expert-driven approach to clinical research documentation.

Avance Clinical Medical Writing Services

Regulatory Writing And Submissions

• Study design
• Clinical study protocols and protocol amendments
• Investigator brochures (IB) and IB updates
• Protocols and protocol reviews
• Participant informed consent forms
• Clinical study reports (CSR)
• Investigational New Drug Applications (IND)
• Patient/Participant Narratives

Supplementary Clinical Trial Documents

• Laboratory manuals
• Pharmacy manuals
• Subject study diaries
• Lay summaries

Scientific And Medical Communication

• Literature reviews
• Manuscripts