Studywright turns clinical trial protocols into complete critical-to-quality assessments, risk registers and monitoring plans aligned to ICH E6(R3).
Request a demoICH E6(R3) made risk-proportionate quality management mandatory. Preparing this documentation takes senior clinical operations staff two to four weeks per study. Those staff are the scarcest resource in clinical research.
Identified with documented rationale, tied to the protocol.
Scored for likelihood, impact and detectability.
Risk-proportionate, matched to the profile of each study.
Every item linked to a protocol section and regulatory principle.
Every output is a draft for qualified human review and approval. Studywright records who approved what, and when.
African clinical research capacity is limited less by sites and participants than by senior clinical operations expertise. Studywright raises how many studies each experienced professional can support, increasing the volume of research the continent can host.
Multilingual informed-consent support, including Swahili and other African languages, is on our roadmap — extending the same efficiency to local research operations.
For research organisations interested in piloting Studywright, we'd welcome a conversation about your regulatory compliance needs.
hello@studywright.com