Description
Investigator's Brochure writing for Singapore and ASEAN trials
The Investigator's Brochure gives investigators and ethics committees the clinical and nonclinical information they need to judge risk and benefit for an investigational product. This service drafts new IBs and maintains existing ones for clinical trials in Singapore and ASEAN markets, integrating preclinical and clinical data into the structure set out in ICH E6.
What you receive
- Complete IB drafting to the ICH E6 section structure
- Updates to existing IBs as new data emerge
- Safety and efficacy summaries from clinical studies
- Integration of preclinical pharmacology, toxicology and pharmacokinetic data
- Clear reference safety information
- Regulatory format compliance for the target markets
How it works
- Collection of study reports and source data
- An IB structure plan and list of missing information
- Drafting and review by your medical and regulatory teams
- Final version delivered, with an agreed schedule for future updates
Standards we follow
IBs follow ICH E6 (GCP) and HSA requirements for clinical trials, together with GPP3, COPE and ICMJE.
Turnaround and price
US$14,055 (approximately S$18,000; exchange rates may vary). The timeline is confirmed after source-data review, based on data volume and your submission date.
Frequently asked questions
Can you update an existing IB?
Yes. We revise it against new data and provide a summary of changes between versions.
How often should an IB be updated?
ICH E6 expects review at least annually and whenever significant new information becomes available. We can schedule updates with your team.
Questions before ordering? Contact our team or request a quote.
