Documents we write
Each to its governing standard
| Document | Standard |
|---|---|
| Study protocols and amendments | ICH E6, with objectives, endpoints and procedures a site can follow |
| Informed consent forms | Plain English and Urdu, tested for readability |
| Investigator's brochures | Compiled and updated from your non-clinical and clinical data |
| Clinical study reports | ICH E3 |
| Clinical performance study plans and reports (IVD) | ISO 20916 |
| Clinical investigation plans and reports (devices) | ISO 14155 |
How we work
Named author, named reviewer
Each document has a named author and a named medical reviewer. We agree a template and a review schedule with you at the start, track every comment to resolution, and deliver a final version with a full version history.