The Resolutum Global medical writing team has experience engaging with the sponsor from protocol synopsis writing to compiling the appendices for the final Clinical Study Report across a broad range of therapeutic areas in early phase trials.
We provide the following services:
- Protocol review or development.
- Protocol amendments.
- Investigator Brochure development.
- Patient Informed Consent Forms and patient information leaflets.
- Clinical Study Reports (interim, abbreviated, full or synopsis).
- Subject safety narratives.