Medical Writing

Medical Writing

Working as a flexible partner, our Medical Writing Solutions team thoughtfully develops accurate messaging for a range of audiences. Whether it’s developing protocols and informed consent forms or a new drug application, we dive into the details to deliver it all with full regulatory compliance.

An enthusiastic team of scientific writers

You require a medical writing company with extensive experience in clinical research and local regulatory understanding to communicate your study results as clearly and swiftly as possible. Our medical writers are carefully chosen for their skill and love of the written word. With solid scientific credentials in a wide range of therapeutic areas and in-depth understanding of GCP and ICH guidelines, our writers are qualified to provide documents with strong scientific foundations quickly. Our goal once you select Bones Medical as your strategic CRO partner for medical writing is to fully comprehend your unique requirements through open communication so that we can provide our services where you need them.

We offer a range of medical writing services, including:

• Investigator’s brochure (IB)
• Clinical performance study protocols (CPSP) and clinical performance study reports (CPSR) for IVDs (ISO 20916)
• Medical communications and safety reports (DSURs/PSURs).
• Clinical investigation plans (CIP) and clinical investigation reports (CIR) for medical devices (ISO 14155)
• Clinical summaries and clinical overviews of the Common technical document (CTD), as well as non-clinical sections.
• Quality control of clinical study documentation
• Clinical evaluation reports (CER) and literature reviews
• Posters, abstracts, manuscripts and other scientific publications.
• Educational and training material, including web and digital content.
• Clinical study protocols (CSP) and clinical study reports (CSR) for drugs and biologics (ICH-E3 and E6)
• Other clinical study documentation such as patient information, informed consent, patient safety narratives, etc.

Functional Service Provider Model

In addition to providing support on an individual clinical trial or project basis, we have extensive experience in building FSPs relationships, offering collaborative and strategic solutions that provide layers of additional benefit to our customers.

The FSP structure builds on our clinical and technical expertise to deliver not only high-quality deliverables, but also provides dedicated resources capable of fully integrating with customers’ teams, providing consistent compound expertise. Our committed FSP leadership provides a performance management of the staff, focusing on developing and retaining personnel within the partnership; ownership of staff productivity; and collaborative process optimization, engaging with customers to explore opportunities for innovation and increased efficiencies within the partnership.