SocraMetrics

What SocraMetrics does

SocraMetrics GmbH is a German clinical research services and proprietary software provider headquartered in Erfurt, with additional offices in Berlin (pharmacovigilance focus) and Dortmund. Originating in 1998 as the data management department of sister CRO SocraTec R&D, the company was incorporated as an independent GmbH in 2007 and today operates as a member of the CERTANIA Gruppe. It serves pharmaceutical companies, clinical trial sponsors, marketing authorization holders and applicants, and medical device companies with a vertically integrated stack of clinical data management, biostatistics, pharmacokinetics, pharmacovigilance, and CDISC regulatory submission services spanning early-phase (First-in-Human, Phase I) through Phase III, observational, and post-authorization studies.

The company builds and operates two proprietary browser-based platforms developed under GAMP-5 validation and FDA 21 CFR Part 11 / EMA Annex 11 compliance: SocraMate, an electronic Case Report Form (eCRF) system featuring touch/smartphone-optimized data entry, complex randomization and stratification, kit/IMP monitoring, edit checks, query management, sponsor oversight reports, audit trails, and CDISC-compliant data structures; and SocraMia, an electronic diary (ePRO) system fully integrated with SocraMate for real-time patient-reported outcomes capture. A third module, DATA Samples, handles biological sample tracking for smaller research facilities that do not require a full LIMS. Statistical programming is SAS-based and validated; pharmacokinetic analysis uses WinNonLin; and CDISC submission packages (CDASH, SDTM, ADaM, define.xml, annotated CRFs) are produced for FDA filings. Pharmacovigilance services include EU-QPPV and UK-QPPV provision, PSMF and RMP management, and signal detection.

SocraMetrics monetizes through two primary models: full-service professional engagements for end-to-end data management, biometrics, pharmacokinetics, and pharmacovigilance (priced per project scope with multi-year contracts), and SaaS subscriptions for organizations self-managing studies on SocraMate and SocraMia (priced annually with server hosting, change management, and updates included). Pricing is quote-based rather than published. Go-to-market is enterprise field sales, augmented by conference presence (AGAH, GBHI), professional society membership (SCDM, German CDISC User Group, BPI), and a content-led website channel. The company employs 21 people and serves clients across Europe, the United States, and additional international markets; no VC/PE backing is indicated.

Name

SocraMetrics

Legal name

SocraMetrics GmbH

Website

https://socrametrics.de

Company type

Private

Founded year

2007

Operating status

Operating

Headcount range

11–50 employees

Short description

SocraMetrics GmbH provides clinical data management, biostatistics, pharmacokinetics, pharmacovigilance, and CDISC submission services to pharmaceutical companies and trial sponsors, supported by proprietary GAMP-5 and CFR 21 Part 11 compliant eCRF and eDiary software platforms.

Ownership category

akta.pro rank

Product category

Clinical Data Management Software

NAICS

Software Publishers (513210), Other Computer Related Services (541519), Scientific Research and Development Services (5417), Other Scientific and Technical Consulting Services (541690)

SIC

Services-Computer Programming, Data Processing, Etc. (7370), Services-Prepackaged Software (7372), Services-Health Services (8000)

akta.pro industry

PRIMARYHLACAOAA

Electronic Data Capture (EDC) Platforms

Healthcare & Life Sciences/Digital Health & Health IT/Clinical Trials & Research Informatics (eCOA/ePRO/EDC)

SECONDARYHLACAOAB

eCOA/ePRO/eDiary & Patient-Facing Data Collection

Healthcare & Life Sciences/Digital Health & Health IT/Clinical Trials & Research Informatics (eCOA/ePRO/EDC)

SECONDARYHLACAOAO

Biostatistics, Statistical Computing & Clinical Programming (SAS/R/Pipelines)

Healthcare & Life Sciences/Digital Health & Health IT/Clinical Trials & Research Informatics (eCOA/ePRO/EDC)

SECONDARYHLAGACAL

Site Data Management Support (EDC/Source/SDV Readiness)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Clinical Trial Services & Site Management (SMO)

Keywords

• Clinical data management
• Pharmacovigilance services
• Electronic data capture
• Clinical trial biometrics
• CDISC compliance

Headquarters

HQ city

Erfurt

HQ country

Germany

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. Full-Service Clinical Data Management: Comprehensive data management solutions where SocraMetrics handles everything from eCRF setup and configuration to data monitoring and analysis. Customers receive complete study support as a service engagement.
2. SaaS eCRF/eDiary Software: Software-as-a-Service model where customers self-manage their studies using SocraMate and SocraMia platforms. SocraMetrics provides server hosting, change management, and software updates while customers handle study setup with basic SQL knowledge.
3. Pharmacovigilance Services: Full range of pharmacovigilance services including setup and maintenance of PV systems, EU-QPPV/UK-QPPV provision, PSMF and RMP management, signal detection, and regulatory compliance services.
4. Biometrics and Pharmacokinetics: Statistical analysis and pharmacokinetic evaluation services using validated SAS and WinNonLin systems, including study design consultation, sample size planning, adaptive designs, and NCA analysis.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

SocraMetrics GmbH provides clinical research services and proprietary electronic data capture (EDC) software for pharmaceutical companies, clinical trial sponsors, and marketing authorization holders. Its core offerings combine full-service clinical data management, biometrics and pharmacokinetics, pharmacovigilance, CDISC-compliant submission packages, and SaaS-based EDC platforms (SocraMate eCRF and SocraMia eDiary/ePRO).

Product overview

SocraMetrics offers a portfolio of proprietary software products and CRO services for clinical research. The core software products are SocraMate (eCRF system) and SocraMia (eDiary/ePRO), both available as SaaS or Full-Service delivery models. These are complemented by DATA Samples, a sample tracking module. The company provides services including clinical data management, biometrics and pharmacokinetics, CDISC standards services, and pharmacovigilance. The product architecture follows a modular approach where SocraMate serves as the central data capture platform, SocraMia handles patient-reported outcomes as an integrated component, and DATA Samples extends functionality for sample management.

Differentiator

Problem solved

Functional benefit

Brands

• SocraMate: Browser-based eCRF (Electronic Case Report Form) system for clinical trials, available as SaaS or Full-Service solution, compliant with FDA 21 CFR Part 11 and EMA Annex 11.
• SocraMia
• DATA Samples

Products and services

• SocraMate (eCRF System) Browser-based electronic Case Report Form (eCRF) system for clinical trial data capture, available as SaaS or Full-Service. Supports touch/smartphone data entry, complex randomization and stratification, kit monitoring and IMP management, edit checks, query management, sponsor oversight reports, data export, efficient monitoring (SDV), medical monitoring, comprehensive audit trail, and data-driven email notifications. Fully compliant with FDA 21 CFR Part 11 and EMA Annex 11.
• SocraMia (eDiary/ePRO System) Browser-based electronic diary (eDiary/ePRO) system for patient-reported outcomes in clinical studies. Allows participants to enter data on their own devices (smartphone, tablet) and is fully integrated with the SocraMate eCRF system, providing real-time access to diary data for study staff to monitor compliance and contact participants.
• DATA Samples Integrated sample tracking and management system for clinical research, developed under GAMP-5 guidelines. Designed for small clinical research facilities where a full LIMS is not cost-effective, allowing management and tracing of biological samples across studies.
• Clinical Data Management Services Full-service clinical data management offering covering eCRF design and setup, data validation, query management, medical monitoring, and study oversight. Tailored to clinical trials across all phases, leveraging SocraMate eCRF technology and validated under GAMP-5 and CFR 21 Part 11.
• Biometrics and Pharmacokinetics Services Statistical analysis and pharmacokinetic evaluation services using validated SAS and WinNonLin systems. Includes study design consultation, sample size planning, adaptive designs, NCA analysis, and pharmacokinetic/pharmacodynamic modeling for early-phase and Phase II studies.
• CDISC Submission Package Services Complete CDISC-compliant data packages prepared to FDA standards, including SDTM datasets, ADaM datasets, define.xml metadata, annotated CRFs, and supporting regulatory documentation for FDA submissions.
• Pharmacovigilance Services Full range of pharmacovigilance services including setup and maintenance of PV systems, EU-QPPV/UK-QPPV provision, PSMF and RMP management, signal detection, periodic safety update reports (PSURs), and benefit-risk assessment for marketing authorization holders and applicants.

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Two partnerships are on record, tiered core.

• SocraTec R&D GmbHcoreStrategic or Co-development Partner · 1 January 2007Closely integrated sister company within the SocraGroup providing full-service CRO capabilities. Companies work hand-in-hand to offer comprehensive solutions: SocraMetrics provides data management, biometrics, pharmacokinetics, and pharmacovigilance while SocraTec R&D offers clinical operations, monitoring, and GCP training services. Joint product development and shared validation standards under GAMP-5 and CFR 21 Part 11.
• CERTANIA GruppecoreOthers · 1 January 2007Parent company group (certania-group). SocraMetrics operates as 'Ein Unternehmen der CERTANIA Gruppe' (A company of the CERTANIA Group), providing integrated services under the group umbrella.

Scale indicators2 records

Recent moves8 records

Expansion highlights6 records

Broad incumbents

• Veeva Systems: Cloud platform provider whose Vault CDB and Vault EDC compete with SocraMate in regulated clinical data capture. Veeva's broader life-sciences CRM and content footprint make it a broad incumbent adjacent to SocraMetrics' SaaS and CDISC services.
• Medidata Solutions: Dassault-owned industry-leading EDC / eCOA / ePRO platform (Rave) used across Phase I–III trials globally. Direct overlap with SocraMate and SocraMia in clinical data capture and patient-reported outcomes, though Medidata operates at vastly greater scale and breadth.
• Clario (formerly CRF Health / Bioclinica): Large clinical trial technology and eCOA vendor (formerly CRF Health) that competes directly with SocraMia in patient-reported outcomes and with broader EDC/endpoint services overlapping SocraMetrics' offerings.
• Oracle Clinical One: Oracle's unified clinical platform (formerly Phase Forward) competes with SocraMate in EDC and with biometric services in CDISC/SDTM data delivery. A broad incumbent serving many of the same global pharma sponsors.

Emerging players

• Climedo Health: Munich-based eCOA and ePRO platform competing in the same mid-market European segment as SocraMia. Comparable as a German-headquartered, emerging digital clinical data vendor focused on patient-facing data collection.

Direct peers

• Castor: Cloud-based EDC platform widely used in academic and mid-market commercial trials, with growing ePRO capabilities. Closely comparable to SocraMate as a focused EDC SaaS targeting non-Phase III and decentralized studies.
• OpenClinica: Open-source and enterprise EDC vendor serving clinical trials with CDISC-compliant outputs. Comparable to SocraMate in providing flexible, regulatory-compliant electronic data capture for small and mid-sized sponsors.
• Clinipace Worldwide (now Worldwide Clinical Trials): Mid-sized CRO offering clinical data management, biostatistics, and pharmacovigilance services similar to SocraMetrics' full-service model. Competes for the same mid-market European and US pharma sponsors.
• DATATRAK: EDC / eClinical SaaS vendor focused on mid-sized and complex clinical trials. Comparable to SocraMate as a purpose-built EDC platform with CDISC-compliant data delivery to sponsors and CROs.

Others

• SocraTec R&D GmbH: Sister CRO within the SocraGroup / CERTANIA Gruppe providing clinical operations, monitoring, and GCP services. Not a competitor but the most strategically integrated partner, jointly delivering full-service studies alongside SocraMetrics.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/socrametrics

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 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 SocraMetrics