At Linical, we understand how important medical writing is to pharmaceutical and biotechnology companies. In an industry where even the slightest mistake can have serious consequences, we offer a service that encompasses preparing scientifically accurate and culturally sensitive documents that are fully compliant with current regulations and adapted to the target audience.
Our medical writers have years of experience preparing clinical documents in a wide range of therapeutic areas including Oncology, CNS and Immunology among others. All medical writing experts are qualified to MSc or PhD level, have full knowledge of industry guidelines and vast experience. Additionally, they undergo regular training conducted by the EMWA(European Medical Writers Association), the AMWA (American Medical Writers Association) and other recognized medical writing organisations to keep their skills sharp.
Our medical writing services are fully compliant with ICH Guidelines and other regulatory requirements currently in force. We strictly follow our internal SOPs or apply our client’s specific SOPs, templates, and writing style for a wide variety of documents, including Regulatory, Clinical and Medical communication materials such as:
- Clinical Study protocols
- Clinical study reports (CSRs, including SAE narratives)
- Investigator brochures, IMPDs
- Clinical overviews and summaries
- Medical source review reports
- Informed Consents
- Final Reports
- Conference abstracts
- Integrated clinical study report (as per ICH E3)
- CTD Module 4 Clinical Summaries & Overall Summary