Life sciences
CASRAI standards for pharmaceutical research administration
Pharmaceutical R&D — from target discovery through Phase IV — operates inside a dense web of research-administration standards: ICMJE authorship, CRediT for contributions, ICH GCP for trials, NSPM-33 + EU AI Act for AI use, and increasingly tight data-sharing mandates from FDA, EMA, and major funders. CASRAI vocabulary bridges the gap between investigator-initiated and sponsored research conventions.
~$1.6T global market (2024)
What this sector cares about
Key research-administration concerns
- CRediT statements on pre-competitive consortia and academic-industry collaborations
- ICMJE authorship criteria + medical-writer disclosure (e.g. EMWA / ISMPP)
- GCP-compliant data management + structured data deposit (CDISC, GA4GH)
- Pre-registration of clinical trials (ClinicalTrials.gov, EU CTIS, ISRCTN)
- Sponsorship and CRO contribution attribution in publications
- AI / ML model disclosure (FDA AI/ML Action Plan, EU AI Act)
Standards in play
Relevant standards beyond CASRAI
- CRediT (ANSI/NISO Z39.104-2022)
- ICMJE Vancouver
- ICH GCP E6(R2/R3)
- CDISC (SDTM, ADaM)
- GA4GH
- FAIR data principles
- ORCID
- RAiD
Typical actors
Who's involved
- Sponsor (pharmaceutical company)
- Contract Research Organisation (CRO)
- Investigator (academic medical centre)
- Medical writer
- Statistician
- Regulatory authority (FDA / EMA / PMDA)
