Medical Trials Analysis

What Medical Trials Analysis does

Medical Trials Analysis (MTA) is a privately held Contract Research Organization (CRO) headquartered in Lugano, Switzerland, with operational offices in Ferrara and Milan, Italy. The company was established in 2005 to reorganize the worldwide scientific involvement of an academic group that originated in the Cardiovascular Research Institute created in 1992 by the Salvatore Maugeri Foundation and the University of Brescia, and the Clinical Research Unit founded in 1996. MTA delivers full-service clinical trial management from Phase I through Phase IV for pharmaceutical, biotechnology, medical device, nutritional, and tech-med sponsors, and operates a consolidated network of academic investigational sites across 29 countries. Its services span feasibility studies, protocol and CRF/eCRF development, regulatory and ethics-committee submissions, investigator meetings, monitoring, data management, safety surveillance, medical review, statistical analysis, medical writing, and study reporting for medicinal products, plus comprehensive EU MDR 2017/745 regulatory and clinical support for medical devices.

MTA's technology stack includes Electronic Data Capture (EDC), an e-PRO system for real-time patient-reported outcomes, and CROm, a proprietary performance-analysis and study-management software developed in-house to support common data management, financial accounting, personnel timesheets, SOP management, and reporting. Supporting offerings include regulatory representation (European Authorized Representative, Swiss Legal Representative, PRRC), EUDAMED registration, CE-marking strategy, clinical evaluation, post-market surveillance, PMCF planning, and quality assurance aligned to ISO 9001 and ICH-GCP standards. The company also runs medical education programs (one-year Master's degrees, two-year post-graduate School in Clinical Research and Epidemiology) with IUSS Ferrara 1391 and the University of Ferrara, and participates in EU-funded research such as the AiPBAND H2020 Marie Skłodowska-Curie training network in brain cancer diagnostics.

MTA operates a professional services, quote-based revenue model with no publicly disclosed pricing. It sells directly to enterprise sponsors through a sales-led motion that is reinforced by industry conference participation (Swiss Biotech Day, Clinical Operations Strategy Meeting Europe, Outsourcing in Clinical Trials Medical Device Europe, Meet in Italy for Life Science, SSFA National Congress), webinars, LinkedIn activity, and memberships in Swiss Biotech Association, AICRO, and AFTI. The company is organized under two legal entities (Medical Trials Analysis Swiss S.A. and Medical Trials Analysis Italy S.r.l.), holds no disclosed outside investors, and is led by named Scientific Directors including Prof. Roberto Ferrari and Dr. Cristina Morelli.

Name

Medical Trials Analysis

Legal name

Medical Trials Analysis

Website

https://mtagroup.net

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

11–50 employees

Short description

Medical Trials Analysis (MTA) is a privately held Swiss-Italian Contract Research Organization founded in 2005, providing full-service Phase I-IV clinical trial management, EU MDR 2017/745 regulatory and clinical services, and data management for pharmaceutical, biotech, medical device, and tech-med sponsors across 29 countries.

Ownership category

akta.pro rank

Product category

Contract Research Organization Services

NAICS

Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (54171)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Health Services (8000)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Patient Recruitment, Site Feasibility & Trial Enablement CROs (HLAGAAAI), Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL), Site Data Management Support (EDC/Source/SDV Readiness) (HLAGACAL)

Keywords

• Clinical trial management
• Contract research organization
• Medical device regulatory services
• Clinical data management
• Pharmaceutical research services

Headquarters

HQ city

Lugano

HQ country

Switzerland

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Research Services - Medicinal Products: Full-service CRO offerings for pharmaceutical products including: feasibility studies, protocol and CRF/eCRF development, regulatory and EC submissions, investigators meetings, monitoring activities, data management, safety surveillance, medical review, quality control, statistical analysis, medical writing, study reporting, project management, and audit services across Phase I to IV.
2. Clinical Research Services - Medical Devices: Comprehensive services for medical device development including: regulatory strategy (gap analysis, EUDAMED registration, CE-marking support), device vigilance/surveillance, quality services (ISO 13485 QMS setup), clinical services (trial documentation, site selection, monitoring, project management), and digital health solutions (e-PRO, data management).
3. Medical Education & Training Services: Educational offerings including: one-year Master's Degree Programs, two-year post-graduated School in Clinical Research and Epidemiology, seminars and workshops, ECM meetings organization, and researcher certifications.
4. Regulatory Services: Regulatory representation and compliance services including: European Authorized Representative (EAR) for non-EU manufacturers, Swiss Legal Representative, PRRC (Person Responsible for Regulatory Compliance) services, regulatory affairs training, and global registration support.

Go-to-market motion3 records

Distribution channels3 records

Marketing channels7 records

Core offering

Medical Trials Analysis (MTA) is an independent Contract Research Organization (CRO) providing full-service clinical trial management for pharmaceutical, biotechnology, medical device, and tech-med companies. The company offers end-to-end clinical research services from Phase I to IV including feasibility studies, protocol development, regulatory submissions, site monitoring, data management, statistical analysis, safety surveillance, medical writing, and quality assurance, with particular specialization in EU MDR 2017/745 compliance and post-market surveillance for medical devices.

Product overview

Medical Trials Analysis (MTA) is a Contract Research Organization (CRO) offering a comprehensive suite of clinical research services for pharmaceutical, biotechnology, nutritional, and medical device industries. The portfolio centers on two core service lines: Medicinal Products Clinical Trial Services (Phase I-IV) and Medical Devices Regulatory & Clinical Services (EU MDR 2017/745 compliance). Supporting these core offerings are specialized modules including Regulatory Services (gap analysis, CE-marking, EUDAMED), Clinical Evaluation & Vigilance Services, Clinical Investigation Services, Digital Health Solutions (e-PRO and EDC), Data Management & Statistics, Quality Assurance Services (including proprietary CROm software), and Researcher Certifications & Medical Education programs. The company also participates in the EU-funded AiPBAND project for brain cancer diagnostics. MTA operates an academic-rooted model with offices in Lugano (Switzerland), Milan, and Ferrara (Italy), maintaining a network of academic investigational sites across 29 countries worldwide.

Differentiator

Problem solved

Functional benefit

Products and services

• Medicinal Products Clinical Trial Services Full-service contract research organization offering expertise and management of all types of clinical trials from Phase I to IV with medicinal products, including feasibility studies, protocol development, regulatory submissions, monitoring, data management, statistical analysis, and medical writing. Targets pharmaceutical companies seeking complete clinical trial management.
• Medical Devices Regulatory & Clinical Services Comprehensive support for medical device manufacturers under EU MDR 2017/745, including regulatory strategy, gap analysis, technical documentation, clinical evaluation, post-market surveillance, PMCF planning, and CE-marking services. Targets medical device manufacturers requiring regulatory compliance and clinical evidence generation.
• Digital Health Solutions Electronic Patient Reported Outcome (e-PRO) tool for real-time patient data collection integrated with Electronic Data Capture (EDC) systems at investigational sites. Captures product-specific information, pain scales, recovery/healing times, patient satisfaction, and adverse events for clinical studies.
• Data Management & Statistics Services Data management services including Data Management Plan development, CRF/eCRF design and review, data validation specifications, edit checks programming and testing, ongoing data review and query management, and custom status reports. Statistical services include protocol design, sample size determination, Statistical Analysis Plan development, and advanced statistical analysis.
• Quality Assurance Services Quality assurance support ensuring ICH-GCP and local regulation compliance, including SOP development, external GCP audits at investigational sites and provider facilities, and QMS set-up/maintenance per ISO 13485.
• Researcher Certifications & Medical Education Medical education services including one-year Master's degree programs, two-year post-graduated School in Clinical Research and Epidemiology, seminars, workshops, ECM meetings, and researcher certifications. Operated in partnership with IUSS Ferrara 1391 and University of Ferrara.
• CROm Software Proprietary performance analysis and study management software developed exclusively by MTA for clinical research operations. Features include common data management, financial accounting (invoice tracking and approval), personnel management via timesheet, quality document templates, SOP management, and reporting extraction.

Quantifiable outcome

• Conduct clinical studies in 29 countries through academic network
• +2 more outcomes

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Ten partnerships are on record, tiered minor and core.

• Swiss Biotech AssociationminorOthers · 1 January 2019MTA is a member of Swiss Biotech Association, gaining industry visibility and networking opportunities within Swiss biotechnology ecosystem.
• AiPBAND ConsortiumcoreStrategic or Co-development Partner · 1 January 2018AiPBAND (An Integrated Platform for Developing Brain Cancer Diagnostics Techniques) is an Innovative Training Network (ITN) funded under EU H2020 Marie Skłodowska-Curie Actions. MTA serves as ESR host site for Early Stage Researcher training in clinical evaluation of tumor biomarkers and diagnostic system development. Brings together nine research institutes and three private sector organizations across Europe and China. Research focuses on early diagnosis of brain tumors using molecular biomarkers in blood.
• Plymouth UniversitycoreStrategic or Co-development Partner · 1 January 2018MTA ESR in AiPBAND project can register as PhD student at Plymouth University upon satisfying enrollment criteria. Plymouth University has a centre of excellence for Brain Tumours providing expertise for the diagnostic system development.
• ACROSS AllianceminorStrategic or Co-development Partner · 1 January 2018ACROSS is the first truly global, agile CRO alliance offering cost-effective, cutting edge innovative solutions for small/medium pharmaceutical and biotech companies as well as public health institutes and NGOs. MTA is a member of this global clinical trials alliance.
• Associazione Farmaceutici Ticinese (AFTI)minorOthers · 1 January 2017MTA Swiss SA became member of AFTI, the Ticino pharmaceutical association, demonstrating local industry engagement in Swiss-Italian region.
• AICRO (Italian Association of Contract Research Organizations)minorOthers · 1 January 2017Full member of AICRO, the Italian Association of Contract Research Organizations, demonstrating professional standing and adherence to industry standards.
• InterACT (International Academic Coordination of Trials)minorStrategic or Co-development Partner · 1 January 1996International scientific network for academic study coordination, monitoring, and data management. Partners combined expertise, networking, data management skills, core laboratories, and international experienced monitors. Basis in UK and Netherlands.
• University of BresciacoreStrategic or Co-development PartnerHistorical founding partner through the Cardiovascular Research Institute created in 1992. Maintained close relationship for academic collaboration and research coordination.
• University of FerraracoreStrategic or Co-development PartnerCurrent academic partner for clinical research coordination. MTA collaborates with University of Ferrara for clinical trials, medical education programs, and prevention awareness initiatives including Ferrara European City of Prevention 2010.
• IUSS Ferrara 1391 (University Institute for Higher Studies)coreStrategic or Co-development PartnerPartnership for organizing medical education including one-year Master's Degree Programs and two-year post-graduated School in Clinical Research and Epidemiology. MTA is partner with IUSS in conducting School for Clinical Research and Epidemiology.

Scale indicators6 records

Recent moves8 records

Expansion highlights6 records

Broad incumbents

• Medpace: Mid-to-large global CRO focused on small and mid-sized biopharma, with full-service Phase I–IV capabilities. While larger than MTA, it competes head-to-head for many of the same sponsor relationships and is a relevant incumbent benchmark.
• IQVIA: Largest global CRO and life sciences technology vendor, offering clinical operations, real-world evidence, and analytical services. Sets the pricing and capability benchmark against which mid-size CROs like MTA compete for sponsor RFPs.
• ICON plc: One of the largest global CROs offering end-to-end clinical, regulatory, and post-approval services across pharma and medical devices. Competes with MTA broadly for sponsor budgets and serves as the upper-scale benchmark on service breadth.

Direct peers

• PSI CRO: European-headquartered full-service CRO running Phase I–IV trials globally, with strong oncology and cardiovascular franchises. Comparable to MTA as a mid-size, therapeutically focused CRO competing for similar sponsor segments.
• Ergomed: UK-based mid-size CRO with strong specialty therapeutic expertise (oncology, rare disease) and pharmacovigilance services. Comparable to MTA in size, European roots, and focus on complex trial delivery for specialty indications.
• Premier Research: Mid-size CRO with specialty expertise in rare disease, oncology, and medical device clinical trials. Comparable to MTA as a mid-tier full-service CRO targeting specialty indications and complex studies.
• Worldwide Clinical Trials: Mid-size global CRO offering full-service Phase I–IV clinical trial management across multiple therapeutic areas, including cardiovascular and medical device indications. Highly comparable to MTA in scale, service breadth, and target sponsor profile, with a similar positioning as a mid-tier alternative to Tier-1 CROs.
• Cromsource: European CRO providing clinical trial management, staffing, and biometrics services across pharma and medical device sponsors. MTA's delivery model, geographic profile, and European mid-size positioning closely mirror Cromsource.
• Clinipace Worldwide: Mid-size global CRO serving small and mid-sized biopharma and device sponsors with therapeutic-area expertise. Comparable to MTA in target customer profile and service breadth despite a US-centric footprint.

Emerging players

• NAMSA: Specialized medical device CRO focused on regulatory, clinical, and laboratory services, with deep EU MDR expertise. Direct comparability to MTA's medical device line of business, particularly around EUDAMED, clinical evaluation, and PMCF work.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/mtagroup

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

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 Medical Trials Analysis