Winicker Norimed

Name

Winicker Norimed

Legal name

Winicker Norimed GmbH

Website

https://winicker-norimed.com

Company type

Private

Founded year

1993

Operating status

Operating

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical Trial Monitoring Support (On-site/Remote) (HLAGACAG)

akta.pro secondary industries

Investigator & Site Training / GCP Support (HLAGACAF), Safety Database Operations & Hosting (Argus/ARISg/Oracle) (HLAGALAB), Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)

Keywords

• Clinical research services
• Contract research organization
• Clinical trial management
• Medical device studies
• Pharmacovigilance services

Headquarters

HQ city

Nürnberg

HQ country

Germany

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Research Services: Full-service Contract Research Organization (CRO) providing clinical trial services including project management, regulatory affairs, biostatistics, monitoring, data management, quality management, medical consulting, safety/vigilance, and medical writing for pharmaceutical and medical device companies
2. Training and Certification Courses: Certified training courses for clinical research professionals including GCP, NIS, GVP, and medical device courses. Courses offered in online, video-present, and in-person formats with CME points from Bavarian Medical Association

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Winicker Norimed is a full-service Contract Research Organization (CRO) providing clinical research services for medicinal products (Phase II-IV trials, non-interventional studies, Real World Evidence) and medical devices (clinical investigations, post-market clinical follow-up). The firm delivers nine integrated service pillars — Project Management, Regulatory Affairs, Monitoring, Biostatistics, Data Management, Quality Management, Medical Consulting, Safety and Vigilance, and Medical Writing — and complements these with a portfolio of CME-certified training courses (GCP, MDR/IVDR, NIS, GVP) delivered in video-present, online, and in-person formats.

Product overview

Winicker Norimed is a full-service Contract Research Organization (CRO) providing comprehensive clinical research services for both medicinal products and medical devices. The company operates as a single integrated service platform spanning all phases of clinical development and post-market activities, including clinical trials (Phase II–IV), non-interventional studies (NIS), Real World Evidence (RWE), and Post Market Clinical Follow-up (PMCF). The portfolio is supported by eleven core service pillars: Project Management, Regulatory Affairs, Monitoring, Biostatistics, Data Management, Quality Management, Medical Consulting, Safety and Vigilance, and Medical Writing. In addition to its CRO services, the company offers a complementary portfolio of certified professional training courses covering GCP, medical device regulations (MDR/IVDR), pharmacovigilance (GVP), and non-interventional studies, which are available in video-lecture, online, and in-person formats. All services are anchored in current regulatory frameworks including EU CTR, AMG, MDR, IVDR, and ICH-GCP standards.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Research Services for Medicinal Products Full-service clinical research support for medicinal products, covering Phase II-IV clinical trials, non-interventional studies (NIS), and Real World Evidence (RWE) generation for pharmaceutical manufacturers across all project phases.
• Clinical Research Services for Medical Devices Clinical research services for medical device manufacturers covering clinical investigations for products on the path to certification and Post-Market Clinical Follow-up (PMCF) studies, supporting MDR/IVDR evidence requirements.
• Clinical Trial Project Management End-to-end project management services for clinical trials and post-marketing projects, coordinating all phases from initiation to completion for pharmaceutical and medical device sponsors.
• Regulatory Affairs Services Regulatory affairs services ensuring compliance with current requirements for medicinal products and medical devices across EU and national frameworks (CTR, AMG, MDR, IVDR, MPDG).
• Clinical Trial Monitoring On-site and remote monitoring services for clinical trials, ensuring investigator and site compliance with study protocols, GCP, and regulatory requirements across medicinal product and medical device studies.
• Biostatistics Services Biostatistical services including study design, sample size calculation, statistical analysis planning, and statistical reporting for clinical trials and non-interventional studies.
• Clinical Data Management Clinical data management services covering database design, data entry, validation, discrepancy management, and database lock for clinical trials, integrated with the EvidentIQ Marvin EDC system.
• Quality Management Services Quality management services including SOP development, audit preparation, and compliance monitoring to ensure adherence to GCP and regulatory standards across clinical research programs.
• Medical Consulting Medical and scientific consulting services providing therapeutic-area expertise and strategic guidance throughout clinical development programs for pharmaceutical and medical device sponsors.
• Safety and Vigilance (Pharmacovigilance) Pharmacovigilance and safety surveillance services including adverse event reporting, signal detection, and compliance with EU and global safety regulations for clinical trials and post-marketing pharmacovigilance.
• Medical Writing Services Medical writing services producing clinical study protocols, clinical study reports, informed consent forms, and regulatory submission documents for medicinal product and medical device sponsors.
• Certified Clinical Research Training Courses CME-accredited training courses for principal investigators, sub-investigators, study staff, and monitors covering Good Clinical Practice (GCP), medical device clinical investigations (MDR/IVDR/MPDG), non-interventional studies (NIS), and Good Pharmacovigilance Practice (GVP), priced per participant with volume discounts.

Quantifiable outcome

• 200+ satisfied clients including long-term partnerships spanning 13+ years
• +2 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

Three partnerships are on record, tiered core and minor.

• TheraLyzecoreTechnology or Integration · 30 April 2026AI-based pharmacovigilance partnership. Winicker Norimed brings 30+ years of clinical research expertise in pharmacovigilance. Together with TheraLyze, they explore AI-based support for ICSR Case Intake and processing of reports from source documents in any language with project-specific flexibility.
• EvidentIQcoreTechnology or IntegrationEvidentIQ is an eCRF (electronic Case Report Form) provider. Winicker Norimed collaborates with EvidentIQ for electronic clinical data capture solutions, with Winicker providing feedback and expertise as a power user of EvidentIQ's Marvin EDC platform.
• ClivolutionminorImplementation/ SI/ Consulting PartnerHR consulting firm that provided expert input at the BVMA Forum 2025 event hosted by Winicker Norimed, offering practical HR insights for the clinical research industry.

Scale indicators6 records

Recent moves9 records

Expansion highlights5 records

Direct peers

• Medpace: Mid-size publicly listed CRO operating globally with full-service clinical development across all therapeutic areas, leveraging an embedded medical and regulatory model—comparable to Winicker Norimed as a mid-sized independent CRO, though at meaningfully larger global scale.
• FGK Clinical Research: Privately held mid-size German CRO based in Munich offering full-service clinical trial management, biostatistics, data management, and regulatory affairs for pharma and medical device sponsors in Europe—directly comparable in size, scope, and DACH market focus to Winicker Norimed.
• Charité Research Organisation: Berlin-based contract research organization affiliated with Charité university hospital, conducting sponsor and investigator-initiated clinical trials in Germany—comparable as a regional German CRO with strong academic and clinical trial execution capabilities.
• Cromsource: Italy-headquartered independent European CRO providing clinical trial, biostatistics, regulatory, and pharmacovigilance services across Europe and North America—comparable to Winicker Norimed as a mid-sized full-service CRO competing for EU-sponsored studies.
• Worldwide Clinical Trials: Mid-size global CRO focused on Phase I–IV and real-world evidence across complex therapeutic areas, including biostatistics, PV, and regulatory consulting—comparable to Winicker Norimed as a similarly sized independent full-service CRO.
• Staburo GmbH: Munich-based biostatistics-focused CRO with clinical trial and pharmacovigilance offerings serving pharma and medical device sponsors—comparable as a German mid-size CRO with overlapping biostatistics, data management, and regulatory services.

Broad incumbents

• Syneos Health: Global full-service CRO and commercialization provider covering clinical development through post-launch—broad incumbent competitor for large multi-region sponsor trials.
• ICON plc: One of the largest global CROs offering full-service clinical development, consulting, and real-world evidence across all geographies—relevant incumbent competitor for multinational sponsor mandates that Winicker Norimed cannot fully cover.
• Parexel International: Large global CRO with deep regulatory, biostatistics, and clinical operations capabilities across all therapeutic areas—typical incumbent competing against mid-size German CROs for international Phase II–IV mandates.
• IQVIA: Largest global CRO with technology-enabled clinical development, RWE, and consulting—operates broadly across all trial phases and geographies, representing the dominant incumbent against which mid-size CROs like Winicker Norimed benchmark.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/winicker-norimed

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 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 Winicker Norimed