AICROS

Name

AICROS

Legal name

AICROS Ltd.

Website

https://aicros.com

Company type

Private

Founded year

1997

Operating status

Operating

Headcount range

51–100 employees

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 CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG), Patient Recruitment, Site Feasibility & Trial Enablement CROs (HLAGAAAI)

Keywords

• Clinical research services
• Contract research organization
• Clinical trial management
• Pharmacovigilance services
• Regulatory affairs consulting

Headquarters

HQ city

Bremen

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Full-Scope Clinical Research Services: Comprehensive clinical trial management services including biostatistics, clinical operations, data management, medical writing, pharmacovigilance, and regulatory affairs. Services range from stand-alone functional support to fully integrated packages for pharmaceutical, biotech, and medical technology sectors.
2. Stand-Alone Services: Targeted support in specific functions such as individual service modules that clients can purchase independently

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

AICROS is an alliance of nine regional CROs delivering full-scope clinical research services for pharmaceutical, biotechnology, and medical technology sponsors. Its offerings span the entire clinical development lifecycle through six integrated service modules — Biostatistics, Clinical Operations, Data Management, Medical Writing, Pharmacovigilance, and Regulatory Affairs — covering Phase I to IV trials, non-interventional studies, and medical device investigations across 80+ countries. Services are sold as either targeted stand-alone functional support or fully integrated end-to-end clinical trial packages tailored to each sponsor's program.

Product overview

AICROS (Association of International Contract Research Organizations) is a global alliance of regional CROs providing comprehensive clinical trial services. Their offering is a unified full-service CRO platform combining six integrated service modules: Biostatistics, Clinical Operations, Data Management, Medical Writing, Pharmacovigilance, and Regulatory Affairs. These services span the entire drug development lifecycle from Phase I to IV clinical trials, non-interventional studies, and medical device investigations. The integrated approach enables sponsors to access flexible and scalable solutions for pharmaceutical, biotechnology, and medical technology sectors through a single network.

Differentiator

Problem solved

Functional benefit

Products and services

• Biostatistics Expert biostatistics support for clinical trials including protocol development, statistical analysis plan (SAP) creation, clinical data analysis using SAS and R programming, CDISC data standardization, and regulatory submission support. Targeted at pharmaceutical, biotechnology, and medical technology sponsors running Phase I to IV trials.
• Clinical Operations End-to-end clinical trial operations including feasibility studies, site selection, contract and finance management, clinical monitoring (on-site, remote, and risk-based), project management, and training for CRAs and investigators. Serves pharmaceutical, biotech, and medical technology sponsors globally.
• Data Management Comprehensive clinical data management services covering electronic data capture (EDC) system design and build, data validation, query management, full CDISC standards implementation (CDASH, SDTM, ADaM), medical and SAE coding, and database lock support for clinical trials.
• Medical Writing Expert medical writing services for regulatory submissions and scientific publications, including clinical study reports (CSRs), study protocols and amendments, investigator's brochures, CTD modules, and patient-facing documents. Targeted at pharma, biotech, and medtech sponsors.
• Pharmacovigilance Comprehensive drug safety monitoring including 24/7 adverse event intake and processing, safety database management using validated Argus platform, ICSR and SUSAR reporting, signal detection, aggregate safety report writing (DSURs, PSURs, PBRERs), and risk management plan development for clinical trials and post-marketing activities.
• Regulatory Affairs Strategic regulatory guidance and submission management including regulatory strategy development, IND/CTA/IMPD preparation, FDA and EMA submissions, health authority interactions, expedited pathway support (Fast Track, Breakthrough, PRIME), and post-approval lifecycle management for pharma, biotech, and medtech sponsors.

Quantifiable outcome

• Over 80 combined years of experience across nearly all therapeutic areas
• +2 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

One partnership is on record.

• Asymchem ClinicalcoreStrategic or Co-development Partner · 12 December 2025Asymchem Clinical joins AICROS as its newest associate partner, significantly enhancing the consortium's capabilities with extensive expertise in China and the broader Asia-Pacific region. This collaboration brings invaluable localized knowledge to AICROS's global network, while allowing Asymchem Clinical to leverage AICROS's international reach to access new geographic regions and niche markets. Asymchem Clinical is recognized as a leading full-service CRO with rapid global expansion, excelling in innovative clinical development strategies, complex trial management, and cutting-edge technology integration across diverse regulatory environments.

Scale indicators6 records

Recent moves1 record

Emerging players

• Cromos Pharma: Emerging mid-size CRO with strong Eastern European / CIS regional expertise and growing global reach. Comparable to AICROS regional CRO members in positioning as 'local expertise with global coverage'.

Direct peers

• Clinipace Worldwide: Mid-size CRO offering full-service clinical development with strong technology-enabled data management. Comparable to AICROS in targeting mid-sized sponsors with flexible engagement models.
• Medpace: Mid-size, full-service clinical CRO with a strong reputation for therapeutic-area expertise and global trial execution. Comparable to AICROS in target customer (small-to-mid pharma, biotech, medical device sponsors) and full-scope service model, though significantly larger and publicly traded.
• Veristat: Specialty CRO focused on biostatistics, data management, regulatory, and medical writing for oncology and complex therapies. Directly overlaps with several AICROS service modules (Biostatistics, Data Management, Regulatory Affairs).
• Premier Research: Specialty mid-size CRO with deep expertise in biotech, rare disease, and medical device studies. Comparable to AICROS in therapeutic breadth and focus on biotech/medical device sponsors needing tailored global execution.
• Worldwide Clinical Trials: Mid-size global CRO focused on complex Phase II–III trials across multiple therapeutic areas. Directly comparable to AICROS in customer base (mid-sized pharma/biotech) and emphasis on mid-size sponsor flexibility.
• Ergomed (acquired by Veeva): Mid-size CRO with strong pharmacovigilance, rare disease, and oncology expertise prior to its Veeva transition. Comparable to AICROS in mid-size CRO positioning and PV/medical device capabilities.
• Novotech: Asia-Pacific-focused mid-size CRO providing clinical trials across Asia, Australia, and the US. Directly comparable to AICROS in serving biotech sponsors needing regional depth combined with global coverage; relevant given AICROS's recent Asymchem Clinical partnership.

Broad incumbents

• IQVIA: Largest global CRO with the deepest biotech/pharma reach and full technology-enabled trial platforms. Provides benchmark competition for any clinical CRO targeting mid-sized sponsors.
• Parexel: Large global full-service CRO with comprehensive Phase I–IV capabilities across pharma and biotech. Operates in the same clinical CRO market as AICROS but with substantially broader scale and global footprint.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Subsidiaries2 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 AICROS