Name

Cunesoft GmbH

Legal name

Cunesoft GmbH

Website

https://phlexglobal.com

Company type

Private

Founded year

2013

Operating status

Acquired

Headcount range

11–50 employees

Ownership category

akta.pro rank

Headquarters

HQ city

Munich

HQ country

Germany

HQ region

Europe

Offices5 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. eTMF Software Subscriptions: SaaS-based electronic Trial Master File software with purpose-built platform solutions including PhlexTMF Enterprise, PhlexTMF Express, PhlexTMF for Viewing, and PhlexTMF for CROs.
2. Professional Services: Expert TMF services including consulting, document processing, quality review, training, study resources, migrations, M&A support, and Veeva Vault support.
3. Per-Study Pricing: Flexible per-study pricing model for PhlexTMF Express, allowing customers to pay for individual study implementations without enterprise-wide commitments.

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels6 records

Core offering

Cunesoft GmbH is a European-headquartered provider of cloud-based regulatory software solutions and services for the life sciences industry. Following its January 2020 acquisition by Phlexglobal, the combined entity delivers a purpose-built eTMF SaaS platform (PhlexTMF) along with vendor-agnostic professional services spanning document processing, TMF quality review, migrations, and regulatory consulting for pharmaceutical, biotech, CRO, and MedTech organizations.

Product overview

Cunesoft GmbH operates as part of Phlexglobal, offering a unified portfolio of purpose-built eTMF software and expert services. The core product suite includes PhlexTMF Enterprise and PhlexTMF Express as the primary electronic Trial Master File platforms, supplemented by PhlexTMF for Viewing (mid-term archive storage), PhlexTMF for CROs, and PhlexTMF for MedTech (ISO14155 compliance). The company provides PhlexTMF+ as an end-to-end managed services wrapper combining all software with expert services. Professional services include Document Processing, TMF Quality Review, TMF Heatmaps, Consulting Services, M&A Support, Study Resources staffing, Migrations & Imports, Expert Training, and Veeva Vault Support. The portfolio is built around AI-powered automation for document indexing and filing, with PhlexTMF Enterprise offering the most comprehensive feature set including intelligent placeholders, wizard-driven completeness tracking, and oversight dashboards. The company also supports the TMF Reference Model as a core industry initiative.

Differentiator

Problem solved

Functional benefit

Products and services

• PhlexTMF Enterprise
• PhlexTMF Express Lightweight, self-serve eTMF solution with online trials, 30-day onboarding, and usage-based pricing for small teams and individual studies.
• PhlexTMF for Viewing
• PhlexTMF for CROs CRO-specific eTMF tier providing multi-sponsor workspace separation, SSO, and scale features for contract research organizations running trials on behalf of multiple sponsors.
• PhlexTMF for MedTech MedTech-specific eTMF solution adapted to medical device clinical investigation documentation requirements, supporting MDR, IVDR, and FDA regulatory frameworks.
• PhlexTMF+ Fully managed TMF service wrapping PhlexTMF software with expert operational services for end-to-end trial master file management.
• TMF Quality Review Service Vendor-agnostic service providing expert TMF completeness, timeliness, and quality review against the TMF Reference Model to support regulatory inspection readiness.
• TMF Heatmaps Visual diagnostic service generating TMF health heat maps to identify completeness, timeliness, and quality gaps across the trial master file.
• Document Processing Service Service for processing, classifying, and indexing clinical trial documents with metadata, supporting both PhlexTMF and third-party eTMF platforms.
• TMF Consulting Services Consulting services providing TMF strategy, regulatory compliance guidance, and operational best practices for life sciences organizations.
• Veeva Vault Support Service Specialist support services for organizations using Veeva Vault eTMF, including document processing, migrations, quality review, and operational support.
• TMF Migrations & Imports Service Service for migrating trial master file content from legacy systems into PhlexTMF or other target eTMF platforms, including data mapping and integrity validation.
• Expert Training Paid training services covering TMF management best practices, regulatory compliance, and platform usage, delivered by Phlexglobal experts.
• M&A Support Service Service supporting clinical trial asset transfer, due diligence, and TMF continuity during mergers, acquisitions, and divestitures.

Quantifiable outcome

• 95% right-first-time document processing accuracy, regardless of volume or system
• +3 more outcomes

Named customers7 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

AI capability4 records

Feature5 records

Partnerships

Five partnerships are on record, tiered flagship and core.

• PharmaLexflagshipStrategic or Co-development Partner · 25 January 2022Merger between PharmaLex Group and Phlexglobal. PharmaLex is a leading provider of specialized services for pharma, biotech and medtech industries. Expands global footprint for clinical and regulatory services.
• PRA Health SciencesflagshipStrategic or Co-development Partner · 23 September 2020Global TMF Center of Excellence partnership. Fit-for-purpose eTMF SaaS software and expert services strengthens PRA customers' confidence in TMF compliance and inspection readiness from plan to archive.
• CunesoftflagshipStrategic or Co-development Partner · 8 January 2020Phlexglobal acquired Cunesoft in January 2020. Expansion into Regulatory Information Management and Artificial Intelligence Technology. Cunesoft India Pvt. Ltd. becomes part of Phlexglobal organization.
• ArkivumcoreTechnology or Integration · 1 January 2020Technical partnership enabling Phlexglobal customers to achieve compliance over entire TMF lifecycle, covering live trial and 25+ year archiving period. Cross-sector expertise in archiving and digital preservation.
• Oracle Health SciencescoreTechnology or Integration · 23 October 2019Enhanced integrations between Oracle Health Sciences eClinical technology and Phlexglobal's TMF technology and services. Accelerates speed and accuracy of regulatory compliance and inspection readiness in clinical trials.

Scale indicators8 records

Recent moves6 records

Expansion highlights6 records

Emerging players

• Ennov: Ennov provides regulatory information management, document management, and quality management software for life sciences. It is a smaller but focused direct competitor in the RIM space serving mid-market pharma and biotech.

Broad incumbents

• IQVIA: IQVIA is a global leader in clinical research services and technology, offering E360, RIM Smart, and broader clinical/regulatory software. It competes with Cunesoft/Phlexglobal across both technology and adjacent CRO services.
• Parexel International: Parexel is a global CRO with significant technology investments (including the LORENZ-adjacent regulatory publishing space). It offers some competing clinical and regulatory technology and is part of the same sponsor procurement ecosystem as Cunesoft/Phlexglobal.
• Dassault Systèmes MEDIDATA: MEDIDATA, part of Dassault Systèmes, offers the Rave Clinical Cloud platform that includes clinical trial, regulatory, and patient engagement technology. It is a broader incumbent in clinical technology with overlapping RIM-adjacent capabilities.
• Oracle Health Sciences: Oracle Health Sciences provides eClinical and clinical trial technology (including former Phase Forward and Siebel CTMS) and is an integration partner of Phlexglobal. It serves overlapping life sciences customers with broader clinical software capabilities.

Direct peers

• ArisGlobal: ArisGlobal provides LifeSphere RIM and other life sciences regulatory technology platforms, including submission management, pharmacovigilance, and clinical software. It is one of the closest direct competitors to Cunesoft's RIM offering for pharma and biotech.
• Veeva Systems: Veeva Systems is the leading provider of cloud-based life sciences software, including Veeva Vault eTMF and Vault RIM. It directly competes with Cunesoft/Phlexglobal in regulatory information management and clinical document management for pharmaceutical companies.
• MasterControl: MasterControl provides quality management, regulatory compliance, and document control software for life sciences manufacturers. It overlaps with Cunesoft/Phlexglobal in regulatory document management and compliance workflows.
• Signant Health: Signant Health provides eCOA, eConsent, and clinical technology solutions for pharmaceutical trials. It competes with Phlexglobal-adjacent clinical technology providers serving the same pharma and CRO customers.
• LORENZ Life Sciences Group: LORENZ specializes in regulatory information management (docuBridge) and electronic submission publishing for life sciences. It directly competes in the same regulatory software niche Cunesoft occupies.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/Cunesoft_GmbH
• LinkedInlinkedin.com/company/cunesoft-gmbh

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds2 records

Investors3 records

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 Cunesoft GmbH