Draft the PSUR sections that need outside evidence, weeks before the deadline.
The agent drafts sections 11, 15 and 16.2 in the ICH E2C(R2) format and traces every figure to its case or publication. Connect your safety database and exposure data, and it drafts sections 5 and 6 too.
SOC 2 Type I
ISO 27001
HIPAA / HDS
- 11Literature: new and significant findings, one sentence per publication, citationsdrafted, traced
- 15Overview of signals: term, source, date, status, action; yours addeddrafted, traced
- 16.2Signal evaluation: cases by source, PRR and ROR, onset, dechallenge, evidence, draftdrafted, traced
- AppendixSources of information: every database, query date and strategygenerated
- 5, 6Exposure and summary tabulationsyour database
- Literature monitoring
- Signal management
- PSUR drafting
Spend the weeks before the deadline on judgement.
KIRHA gathers the literature, signals and evaluation evidence that a PSUR draws from several teams.
Start writing with the evidence gathered
Gathering a year of articles, monitoring runs and signal decisions can take an author weeks before writing starts. The agent gathers and drafts that evidence, so the weeks before the deadline go on review.
Keep the sections consistent
Section 11 comes from the literature record your weekly screen kept, and sections 15 and 16.2 from the monitoring runs your signal team reviewed, so the PSUR, the signal log and the literature record give the same figures.
Open every figure at its source
Each count, ratio and citation links back to the case identifiers, the data extract or the publication. The sources appendix lists every database, query date and search strategy. Your author and your medical reviewer check a sentence by opening its source.
Follow each product's PSUR cycle
It follows each product's required PSUR interval and can also run between cycles. Drafts arrive in Word, in E2C(R2) section numbering, ready for your own template.
The drafts come from the same runs as literature monitoring and signal management, so each piece of evidence is gathered once.
Get sections 11, 15 and 16.2, every figure traced.
In Word and in E2C(R2) numbering, ready to paste into your template or your provider's.
Literature
Summarises each new safety finding from the interval's literature in one sentence, cites it in Vancouver style and appends the search strategy.
Overview of signals
Lists every signal from the interval's monitoring and every public signal on the substance, with its source, date, status and action. You add your own.
Signal evaluation, per signal
Gathers the cases, disproportionality figures, timing, stop-and-restart outcomes, patient profile, confounders and literature, then drafts the evaluation, with every number linked to its case or publication.
Sources of information, and an optional completeness check
Lists every database queried, with dates and strategies, and can flag where the public record counts more cases than your tabulation.
Questions
Start with a tailored analysis of one substance.
Tell us the substance and the PSUR interval. We draft sections 11, 15 and 16.2 with the sources appendix and walk your author through them.
- SOC 2 Type I
- ISO 27001
- HIPAA / HDS