Medical Writing

Getting a clinical protocol approved is a critical milestone in a company’s development. In addition to a protocol itself, there are numerous ancillary materials to be developed – appendices and guidelines, patient information forms, case report forms, and contracts.

Furthermore, clinical trial recruitment requires effective communication with patients – both initially and over the course of the trial. Offering patient-facing educative materials to your sites is appreciated by the Principal Investigator and their staff, and is also appreciated by patients.

After a trial has started, there is an ongoing need to document progress – including adverse events – to regulatory bodies and collaborators, and to evaluate data as it becomes available. Manuscripts must also be written for peer-reviewed journals.

Our approach in writing early-stage protocols and ancillary materials is based around logic, attention to detail, and consistency. When developing a protocol, we combine careful consideration of the safety of the subject, the reality of clinical practice, and a scientific approach to data collection and evaluation.

Effective data collection primarily comes from thoughtful case report form design for an electronic data collection system. High quality interim reports for regulatory bodies are based on the clear and consistent presentation of events and data.

We find great satisfaction in generating the best possible documents for clinical trial set up and maintenance, and would be delighted to help you with your process.