CW-Research & Management GmbH

What CW-Research & Management GmbH does

CW-Research & Management GmbH is an independent European Contract Research Organization (CRO) headquartered in Munich, Germany, with additional offices in Vienna and Adlwang, Austria. The company provides end-to-end clinical trial services to pharmaceutical, biotechnology, and medical device sponsors, as well as digital health application (DiGA) manufacturers, and has been operating in clinical research for over three decades. Its service portfolio covers the full clinical study lifecycle including study planning and preparation, clinical monitoring, data management, biometrics, medical writing, quality assurance, regulatory affairs consulting, risk management, project management, coding services, and a dedicated Study Governance and Oversight module spanning sponsor oversight, site activation, inspection readiness, audit support, vendor oversight, and cross-border coordination.

The firm's operating model is built on three explicit pillars: a governance-first approach that establishes regulatory frameworks, controls, and responsibilities at study initiation; senior-led execution that pairs clients with experienced professionals rather than rotating junior teams; and realistic, risk-based planning intended to keep studies on time and within budget. It is EN ISO 9001:2015 certified (TÜV) and positions itself around European regulatory frameworks including EU Regulation 536/2014, the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR), and the ICH E6(R3) Good Clinical Practice guideline. The company distributes services exclusively through direct, project-based professional services contracts negotiated after initial non-binding consultations, with no disclosed intermediaries, resellers, or subscription products. Management is led by Christian Wolflehner, a clinical trial specialist trained at the Medical University of Graz who serves as Managing Director, certified Quality Lead Auditor, and data protection officer.

Name

CW-Research & Management GmbH

Legal name

CW-Research & Management GmbH

Website

https://cw-rm.com

Company type

Private

Operating status

Operating

Headcount range

1–10 employees

Short description

CW-Research & Management GmbH is an independent European CRO with offices in Munich, Vienna, and Adlwang, providing end-to-end clinical trial services (planning, monitoring, data management, biometrics, regulatory affairs, and governance oversight) to pharmaceutical, biotechnology, medical device, and digital health sponsors under ICH E6(R3) and MDR/IVDR frameworks.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) 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)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Clinical Trial Monitoring Support (On-site/Remote) (HLAGACAG), Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

Keywords

• Clinical research services
• Contract research organization
• Clinical trial management
• Regulatory affairs consulting
• Medical device studies

Headquarters

HQ city

Munich

HQ country

Germany

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Trial Services: Professional services revenue generated through comprehensive CRO services including study planning, monitoring, data management, biometrics, medical writing, quality assurance, and regulatory consulting. Services are provided on a project/contract basis tailored to specific sponsor requirements.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

CW-Research & Management is an independent European CRO that provides end-to-end clinical trial services for pharmaceutical, biotechnology, and medical device sponsors. Its core offerings cover study planning and preparation, clinical monitoring, data management and biometrics, medical writing, quality assurance, regulatory affairs consulting, and study governance/oversight. The firm emphasizes ICH E6(R3)-compliant oversight, risk-based quality control, and senior-led execution delivered through project-based contracts.

Product overview

CW-Research & Management GmbH is an independent European CRO providing comprehensive clinical trial services. The company offers a unified service portfolio centered around clinical trial management, combining study planning, monitoring, data management, quality assurance, and regulatory consulting into an integrated offering. Key service modules include study planning and preparation, clinical monitoring, quality assurance, data management with biometrics, medical writing, regulatory affairs, and project management. The company emphasizes its governance-first approach, risk-based quality control, and ICH E6(R3)-compliant study oversight throughout the clinical trial lifecycle.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Trial Management Services Comprehensive CRO services covering the entire lifecycle of clinical studies for pharmaceutical, biotechnology, and medical device sponsors, including planning, execution, monitoring, data management, and regulatory compliance.
• Clinical Monitoring Services Continuous monitoring services to ensure data quality, regulatory compliance, and participant safety throughout clinical study execution for sponsors.
• Data Management and Biometrics Structured collection, organization, coding, and statistical analysis of clinical trial data to ensure data integrity, compliance, and valid study results.
• Medical Writing Services Creation of clear, precise, and regulatory-compliant clinical and regulatory documentation derived from trusted and verified data sources.
• Regulatory Affairs Consulting Expert consultation on regulatory submissions, MDR/IVDR compliance, ethics committee coordination, and authority interactions for clinical trials and performance studies across the EU, Germany, and Austria.
• Study Governance and Oversight Sponsor oversight support including efficient site activation, inspection readiness, audit support, vendor oversight, and cross-border coordination for multi-jurisdictional European clinical trials.
• Quality Assurance Services Regular independent audits and continuous quality control to ensure compliance with regulatory requirements and the highest safety standards throughout the clinical study lifecycle.

Quantifiable outcome

• Studies completed on time and within budget through realistic planning and proactive risk management

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators2 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• PPH plus GmbH & Co. KG: PPH plus is a German CRO based in Augsburg providing clinical trial management, monitoring, data management, and biometrics for pharma and medical device sponsors. Comparable to CW-R&M in size, geographic focus on Germany, and emphasis on quality management and ISO certification.
• Accovion GmbH: Accovion (formerly ClinStar) is a Frankfurt-based European CRO focused on clinical trial management, biometrics, regulatory affairs, and post-marketing studies across CEE and Western Europe. Directly comparable to CW-R&M on service mix (CRO + biometrics + regulatory) and European mid-cap sponsor focus.
• Charité Research Organisation GmbH: Charité Research Organisation is a Berlin-based German CRO spun out of the Charité hospital, providing clinical trial management, monitoring, biometrics, and regulatory consulting for academic and industry-sponsored studies. Comparable to CW-R&M in mid-size European CRO positioning with deep regional regulatory expertise.
• FGK Clinical Research GmbH: FGK is a Munich-based independent CRO offering Phase I–IV clinical trial services, biostatistics, data management, and regulatory affairs for pharma, biotech, and medical device sponsors in Europe. It is the closest direct competitor to CW-R&M on geography (Germany), service portfolio, and mid-cap sponsor target segment.
• Smerud Medical Research International AB: Smerud is a Nordic/European CRO headquartered in Norway with operations in Sweden, Denmark, Finland, the UK, Germany, and Switzerland, offering clinical trial management, regulatory affairs, biometrics, and medical writing. Comparable to CW-R&M as a mid-size independent European CRO with a similar governance-led value proposition and cross-border execution.

Broad incumbents

• Parexel International Corporation: Parexel is a global CRO (currently owned by EQT and Goldman Sachs) offering full-service clinical development, regulatory, and post-approval services across all major therapeutic areas and geographies. Comparable as a global incumbent setting the competitive ceiling on mid-cap European CRO engagements.
• Medpace Holdings, Inc. Medpace is a US-headquartered mid-to-large CRO with significant European operations, known for a full-service model focused on small-to-mid-cap biotech sponsors. Comparable as a broad incumbent whose 'science-first' positioning parallels CW-R&M's governance-led approach at much larger scale.
• Syneos Health: Syneos Health is a global CRO and commercialization services provider with biopharma customers across Europe, North America, and Asia. Comparable broad incumbent competing for clinical trial services work in Germany and Austria alongside CW-R&M.
• IQVIA Holdings Inc. IQVIA is the largest global CRO and life sciences services provider, offering full-spectrum clinical, technology, and data services. Relevant as the dominant incumbent against which CW-R&M competes for mid-cap sponsor trials in Europe; broader scale and technology stack but less specialized governance focus.
• ICON plc: ICON plc is a global CRO with extensive European operations formed in part through the PRA Health Sciences merger, offering Phase I–IV clinical services, labs, and decentralized trial technology. Comparable broad incumbent competing for the same European sponsor RFPs as CW-R&M.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/cw-research-und-management-gmbh

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 CW-Research & Management GmbH