OPIS (a KCR Group Company)
↗Desio (Milan), Italy
OPIS is a leading full-service European Clinical Research Organization (CRO) founded in 1998. Headquartered in Italy, the company provides comprehensive clinical trial management services from Phase I to IV, including study design, regulatory affairs, medical writing, and data management. OPIS is known for its proprietary e-clinical suite, Clinical.net, which is a fully FDA 21 CFR Part 11 compliant EDC solution.
In early 2024, OPIS was acquired by KCR (Keele Clinical Research), a global CRO. Subsequently, in August 2024, ICON plc acquired KCR, effectively making OPIS part of the ICON global network. This series of acquisitions has integrated OPIS's deep European expertise into one of the world's largest clinical research infrastructures, enhancing its ability to support large-scale, multi-country trials.
CLASSIFICATION
SIZE & FINANCIALS
Employees:201-500
Revenue:$10M-$50M (OPIS standalone)
Founded:1998
Ownership:subsidiary
Status:acquired
FUNDING
Stage:Acquired
STOCK
Exchange:NASDAQ (Parent: ICLR)
Ticker:ICLR
Market Cap:$18B-$22B (Parent: ICON plc)
PIPELINE
Stage:Commercial
Lead Drug Stage:Phase 4 (Service provider for all phases)
Modalities:Small molecule, mAb, Cell therapy, Gene therapy, Medical Devices, Nutraceuticals
Active Trials:1500
Trial Phases:Phase 1: 200 | Phase 2: 400 | Phase 3: 600 | Phase 4: 300
FDA Approvals:0
EMA Approvals:0
CORPORATE STRUCTURE
Parent Company:ICON plc
Acquired By:KCR (subsequently ICON plc) (2024-01-01)
Subsidiaries:OPIS Germany, OPIS Spain, OPIS France, OPIS UK
Key Partnerships:FindMeCure (TrialHub) for clinical trial feasibility, Various European academic research centers
COMPETITION
Position:Niche Player
Competitors:IQVIA, Medpace, Parexel, Syneos Health, PPD (Thermo Fisher), Optimapharm
LEADERSHIP
Key Executives:
Alda Gatti - Founder & CEO (OPIS)
Mike Jagielski - CEO (KCR)
Scientific Founders:Alda Gatti
LINKS
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