Life sciences
CRediT, authorship, and contribution standards for CROs
Contract Research Organisations sit between sponsors and investigators on most clinical trials — running operations, biostatistics, medical writing, data management, and regulatory submissions. Increasingly the CRO contribution to peer-reviewed publications must be attributed properly under CRediT and ICMJE; medical-writer disclosure (via EMWA / ISMPP / GPP3) is a regulatory expectation.
~$80B global CRO market (2024)
What this sector cares about
Key research-administration concerns
- Attributing CRO biostatistics, data management, medical writing in CRediT statements
- GPP3-compliant good publication practice for industry-sponsored publications
- Sponsor + CRO + investigator three-way contribution patterns
- Ghost-writing prevention (EMWA / ICMJE)
- Trial-registration + data-sharing compliance across portfolios
- CDISC-conformant data deposit for industry trial outputs
In trials with translational arms, contribution records increasingly need to capture lab-side work such as pharmacogenomic testing alongside the clinical authorship, a CRediT-meets-CRO attribution gap that CASRAI helps close.
Standards in play
Relevant standards beyond CASRAI
- CRediT
- ICMJE
- GPP3 (Good Publication Practice)
- EMWA / ISMPP medical-writer policies
- ICH GCP
- CDISC SDTM/ADaM
Typical actors
Who's involved
- CRO biostatistician
- CRO medical writer
- CRO clinical data manager
- Sponsor publication lead
- Investigator (lead author)
Going deeper
