ISS/ISE


Integrated Safety (ISS) and Efficacy (ISE) summaries are part of CTD/eCTD submission modules and summarize IMP’s overall safety and efficacy in all long and expensive clinical development process.
• ClinScript has extensive experience in preparing dozens of CTD/eCTD submissions, from straightforward local variations to complex global submission dossiers for multiple indications.

• Our clients appreciate ClinScript’s proactive involvement in ensuring that all aspects of the clinical development program are appropriately synthesized in a reviewer-friendly manner.

• ClinScript meets deadlines – a vital factor in successful and timely drug approvals.