Clinical Trial Center S.P.A.

What Clinical Trial Center S.P.A. does

Clinical Trial Center S.p.A. (CTC) is an Italian clinical research organization operating as the wholly-owned subsidiary of Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Founded in January 2013 and incorporated as a Società per Azioni in July 2017, the company is the first Italian spin-off established within a hospital structure. CTC provides Site Management Organization (SMO), Contract Research Organization (CRO), and pharmacovigilance services through two operational units: a Research & Development unit handling clinical trial coordination, GCP-compliant training, pharmacovigilance, and regulatory submissions; and an Operations unit handling site management, budgeting, contract negotiation, ethics committee liaison, and legal/administrative functions.

The company's technology stack is operational rather than platform-based, centered on clinical trial management workflows, safety project management, adverse event collection, regulatory notifications, and 24/7 pharmacovigilance coverage. Core service lines include SMO administrative management of profit clinical trials at Fondazione Policlinico Gemelli, R&D services for protocol review and compliance, and modular drug and device vigilance services. Pricing is quote-based and negotiated per study with pharmaceutical sponsors; no pricing is publicly disclosed.

CTC serves three primary customer segments: pharmaceutical companies (sponsors) seeking to run profit clinical trials, healthcare facilities and clinical investigators needing operational support, and public/private foundations and scientific societies funding non-profit trials. Revenue is generated on a per-study transaction fee and professional services basis. The company operates exclusively in Italy from multiple addresses in Rome, with parent governance via Fondazione Policlinico Gemelli (sole shareholder since September 2022) and external audit by Deloitte & Touche S.p.A. Strategic positioning is reinforced by President Guido Rasi, the Past Executive Director of the European Medicines Agency.

Name

Clinical Trial Center S.P.A.

Legal name

Clinical Trial Center S.p.A.

Website

https://clinicaltrialcenter.it

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

5,001–10,000 employees

Short description

Clinical Trial Center S.p.A. is an Italian clinical trial management organization and wholly-owned subsidiary of Fondazione Policlinico Universitario Agostino Gemelli IRCCS, providing SMO, CRO, and pharmacovigilance services to pharmaceutical sponsors and clinical investigators operating at the Gemelli hospital site in Rome.

Ownership category

akta.pro rank

Product category

Clinical Trial Management Services

NAICS

Scientific Research and Development Services (5417), Professional, Scientific, and Technical Services (54)

SIC

Services-Health Services (8000)

akta.pro primary industry

Site Network Operators & SMOs (HLAGACAA)

akta.pro secondary industries

Clinical Trial Site Operations & Study Coordination (HLAGACAE), Clinical Operations & Monitoring FSP (CRA/CTM/Start-up) (HLAGAOAA), Clinical Trial Monitoring Support (On-site/Remote) (HLAGACAG), Site Quality Management & Audit Readiness (HLAGACAN)

Keywords

• Clinical trial management
• Site management organization
• Pharmacovigilance services
• Contract research organization
• Good clinical practice training

Headquarters

HQ city

Rome

HQ country

Italy

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales, Others

Revenue model

1. SMO Administrative Management Services: Fees charged to pharmaceutical sponsors for administrative management of profit clinical trials, including budget negotiation, contract management, ethics committee liaison, and sponsor invoicing. Revenue is generated per study, with services spanning study setup, execution, and closeout.
2. Research & Development Services: Fees for R&D services including safety project management, pharmacovigilance, regulatory submissions, and compliance monitoring. Services are tailored to study complexity and sponsor requirements, with 24/7 support coverage.
3. Clinical Training and GCP Education: Providing specific training for the conduct of profit and non-profit clinical trials in good clinical practice (GCP) to investigators and research staff.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

Clinical Trial Center S.p.A. provides site management organization (SMO) and clinical trial support services for pharmaceutical sponsors and healthcare facilities operating clinical trials at Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome. Its two operational units — Operations (SMO) and Research & Development — deliver budget negotiation, contract execution, ethics committee liaison, pharmacovigilance, protocol review, regulatory compliance, and GCP training for both profit and non-profit clinical studies.

Product overview

Clinical Trial Center SpA operates as a specialized clinical research organization offering two integrated service lines: the Operations Unit (SMO) providing site management, budgeting, pricing, administration and legal services for trial coordination; and the Research & Development Unit delivering pharmacovigilance, protocol review, regulatory compliance and monitoring services. The company also provides CRO services as an add-on module. All services are designed to support pharmaceutical companies, healthcare facilities, and investigators in conducting clinical trials efficiently in compliance with Good Clinical Practice.

Differentiator

Problem solved

Functional benefit

Products and services

• Operations Unit — Site Management Organization (SMO) Services Administrative management of profit clinical trials conducted at Fondazione Policlinico Gemelli. Handles study budget development, contract negotiation, ethics committee liaison, clinical protocol review, invoicing to pharmaceutical sponsors, and final reporting to clinical investigators.
• Research & Development Unit — Clinical Trial Coordination Services Clinical trial coordination services for both profit and non-profit trials, including safety project management, clinical protocol review, adverse event collection and follow-up, regulatory notifications, safety data exchange agreements, insurance and regulatory compliance monitoring, GCP training, and 24/7 coverage with research strategy support.
• Pharmacovigilance and Device Vigilance Services

Quantifiable outcome

• One euro invested in a clinical study generates approximately 2.95 EUR in benefits for the Italian National Health Service (SSN); in oncology trials the leverage reaches 3.35 EUR. Average oncology study costs 512,000 EUR but avoids over 1 million EUR in care costs.

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Four partnerships are on record, tiered core and minor.

• Fondazione Policlinico Universitario Agostino Gemelli IRCCScoreOthersClinical Trial Center S.P.A. is a wholly-owned subsidiary (Socio Unico) of Fondazione Policlinico Universitario Agostino Gemelli IRCCS, established as the first Italian spin-off within a hospital structure. The CTC operates within and leverages the hospital's infrastructure, patient populations, and clinical expertise. The foundation's Director General (Marco Elefanti) provides ongoing support to CTC activities.
• FOCE (Federazione degli oncologi, cardiologi e ematologi)minorStrategic or Co-development PartnerCTC President Guido Rasi participated in the FOCE national congress on 'Il valore della ricerca clinica in oncologia, ematologia e cardiologia' held in Rome in March 2023, alongside the Italian Minister of Health and heads of ISS, AIFA, and other national health bodies.
• Assobiotec (Federchimica)minorStrategic or Co-development PartnerGuido Rasi, President of CTC, participated in an Assobiotec-convened conference in April 2023 on pharmaceutical innovation, access, and clinical trial value, alongside industry leaders, policymakers, and institutional decision-makers.
• Roche ItaliaminorStrategic or Co-development PartnerGuido Rasi spoke at Roche Italia's 125th anniversary celebration event in December 2022, discussing 'Sanità del Futuro' and stakeholder engagement in the health system, alongside Roche's leadership and other healthcare industry figures.

Scale indicators3 records

Recent moves7 records

Expansion highlights4 records

Broad incumbents

• ICON plc: Large global CRO with full clinical operations, site services, and laboratory capabilities. Directly comparable to CTC's CRO/SMO offerings for pharmaceutical sponsors, with established European delivery centers including Italy.
• Syneos Health: Global clinical and commercial solutions provider; its clinical segment delivers CRO and site solutions. Direct overlap with CTC's sponsor-facing clinical operations, SMO, and pharmacovigilance offerings.
• IQVIA: Global CRO/SMO providing clinical operations, site management, pharmacovigilance, and real-world evidence across 100+ countries. Overlaps with CTC on SMO, monitoring, pharmacovigilance, and regulatory services for pharma sponsors, but at vastly broader geographic and therapeutic scale.
• Medpace Holdings: Mid-to-large CRO delivering full-service clinical operations across therapeutic areas with strong European footprint. Comparable to CTC's CRO/SMO service model and target customer base (pharma sponsors).
• Labcorp Drug Development (formerly Covance): Large CRO offering clinical operations, central laboratory, and site support services globally. Overlaps with CTC's CRO, pharmacovigilance, and clinical monitoring modules for sponsor customers.
• Parexel International: Major global CRO offering clinical operations, pharmacovigilance, regulatory consulting, and site support. Competes with CTC for the same pharmaceutical sponsors for European multi-country trials and shares overlap in monitoring, safety, and study start-up.
• Worldwide Clinical Trials: Mid-size global CRO with strong European presence, offering clinical operations, pharmacovigilance, and bioanalytical services. Comparable to CTC's full-service CRO/SMO offering for pharma sponsors across therapeutic areas.

Direct peers

• TFS International: Europe-headquartered mid-size CRO providing clinical operations, pharmacovigilance, and regulatory services. Highly comparable to CTC's CRO/SMO service mix, particularly for European-headquartered sponsors running multi-site trials.
• CRS Clinical Research Services: Boehringer Ingelheim-affiliated European CRO providing full-service clinical operations and SMO-like coordination. Closely comparable to CTC in size, European focus, and mix of clinical operations plus pharmacovigilance for pharmaceutical sponsors.

Others

• Medidata Solutions (Dassault Systèmes): Clinical trial technology platform provider for EDC, monitoring, and trial management used by CROs/SMOs and sponsors. Adjacent to CTC's clinical trial coordination work as a technology enabler rather than a competing service provider.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• YouTubeyoutube.com/@clinicaltrialcenter-gemelli
• Facebookfacebook.com/CTCGemelli
• LinkedInlinkedin.com/company/fondazione-policlinico-universitario-agostino-gemelli-irccs
• Instagraminstagram.com/ctcgemelli

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds1 record

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Clinical Trial Center S.P.A.