Opis Research

Opis Research

Milan, Italy· Est.
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Private Company

Funding information not available

Overview

Opis Research is a private, Milan-based clinical CRO offering end-to-end clinical development services from study design through to data analysis and reporting. Founded in 2015, it has established itself as a specialized partner for complex trials in oncology, hematology, CNS, rare diseases, and advanced therapies, supported by a proprietary EDC system, Clinical.net. The company is revenue-generating, operates with a flexible business model, and maintains key quality certifications (ISO 9001, ISO 27001, FDA 21 CFR Part 11 compliant), serving pharmaceutical, biotech, and medical device clients globally.

NeuroscienceOncologyHematologyOphthalmologyRare DiseasesCardiovascular DiseasesRespiratory DiseasesInfectious DiseasesPediatrics

Technology Platform

Proprietary electronic data capture (EDC) and clinical trial management system called Clinical.net, a fully customizable modular framework developed in-house. Supported by ISO 9001, ISO 27001, and FDA 21 CFR Part 11 compliant systems.

Opportunities

Growing demand for specialized CRO services in complex therapeutic areas like oncology, rare diseases, and advanced therapies (ATMPs).
Expansion into new geographic markets (e.g., India) and the increasing need for real-world evidence (RWE) studies present significant growth avenues.
The proprietary Clinical.net platform offers a competitive differentiator and potential for technology-led service expansion.

Risk Factors

Faces intense competition from large global CROs and niche players.
Revenue is project-dependent and vulnerable to client concentration and trial delays/cancellations.
Inherent operational risks include regulatory compliance failures, data security breaches, and challenges in retaining specialized talent in a competitive market.

Competitive Landscape

Operates in the highly fragmented and competitive global CRO market. Competes with large, full-service multinationals (e.g., IQVIA, ICON, Parexel, PPD) for major contracts, and with numerous small-to-mid-sized regional and specialty CROs. Differentiation is based on therapeutic expertise (CNS, Oncology), proprietary technology (Clinical.net), and a quality-focused, flexible service model.