Differentiators
Diverse experience across various therapeutic areas with over 150,000 narratives
Successful execution of multiple large narrative programs including complex narratives
Unique blend of expertise across various health authority requests including IDMC, real time, 4MSU/120-day and adjudication narratives
Expert medical review in niche areas including vaccines, medical devices and rare diseases
Delivering submission-ready clinical narratives
Scalable model with flexi pool and easy ramp-up
SIRO Narrative Experience Across All Major TAs
Case Studies
NARRATIVE CASE STUDY 1
A large narrative program for a blockbuster molecule with stringent timelines for a critical regulatory submission for a cardiovascular indication.
NARRATIVE CASE STUDY 2
Adjudication narrative requirement for a critical regulatory submission for a metabolic disorder indication.