SocraTec R&D

What SocraTec R&D does

SocraTec R&D GmbH is a German full-service Contract Research Organization (CRO) founded in 1998 by Professor Henning Blume and Dr. Barbara Schug, headquartered in Oberursel with its main Clinical Pharmacology Unit (CPU) in Erfurt. The company delivers clinical trial services from Phase I through Phase IV plus non-interventional (post-authorisation safety, efficacy, and drug utilisation) studies, with a particular emphasis on early-phase clinical pharmacology: first-in-human studies, bioequivalence/bioavailability (BA/BE) trials, pharmacokinetics, drug-drug and drug-food interaction studies, and biosimilar PK studies. Core technical assets include a 54–60 bed modular CPU in Erfurt, a 6-bed intensive monitoring unit embedded in Helios Klinikum Erfurt for FIH and high-risk studies, CSF sampling capability, Siemens-based central surveillance, and CDISC/CDASH-compliant data management via the wholly-owned subsidiary SocraMetrics GmbH, which also runs Phoenix WinNonlin-based non-compartmental PK analyses for EU and FDA submissions.

The business sells professional services to pharmaceutical and biotech sponsors, structured as either full-service packages or modular offerings (design development, scientific advice, project management, monitoring, data management, biostatistics, medical writing, quality assurance, expert statements). Customer segments are diversified across early-phase pharma, later-phase pharma, non-interventional / post-marketing studies, and generic drug manufacturers, with therapeutic depth in BA/BE, transdermal systems, ophthalmology, gynaecology, pediatrics, oncology, and OTC products. Marketing is conducted through scientific publications, conference participation (GBHI, GPTS, AGAH, EUFEPS, Outsourcing in Clinical Trials Europe), LinkedIn, and GCP training courses co-organized with University Hospital Jena and the Thuringian Medical Association. The company remains privately held and founder-controlled, with two wholly-owned subsidiaries (SocraMetrics for biometrics/data management and SocraTec C&S for consulting) and no external institutional investment disclosed.

Name

SocraTec R&D

Legal name

SocraTec R&D GmbH

Website

https://socratec-pharma.de

Company type

Private

Founded year

1998

Operating status

Operating

Headcount range

51–100 employees

Short description

SocraTec R&D GmbH is a privately held German full-service Contract Research Organization founded in 1998, providing Phase I–IV clinical trials and non-interventional studies to pharmaceutical and biotech sponsors, with particular strength in early-phase bioequivalence, pharmacokinetics, and first-in-human studies.

Ownership category

akta.pro rank

Product category

Contract Research Services (Clinical Research Organization)

NAICS

Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (54171), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Medical Laboratories (8071)

akta.pro industry

PRIMARYHLAGAAAA

Clinical CROs (Phase I–IV)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Research Organizations (CRO)

SECONDARYHLAGAAAL

Specialty Therapeutic-Area CROs (e.g., oncology/rare disease)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Research Organizations (CRO)

SECONDARYHLAGAAAF

Clinical Data Management, Biostatistics & Statistical Programming CROs

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Research Organizations (CRO)

SECONDARYHLAGAAAI

Patient Recruitment, Site Feasibility & Trial Enablement CROs

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Research Organizations (CRO)

SECONDARYHLAGAAAG

Medical Writing & Regulatory Submission Support CROs

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Research Organizations (CRO)

Keywords

• Clinical research services
• Contract research organization
• Bioequivalence studies
• Pharmacokinetic analysis
• Early phase trials

Headquarters

HQ city

Oberursel

HQ country

Germany

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Marketing or Sales

Revenue model

1. Clinical Research Services: Full-service CRO providing comprehensive clinical trial services including design development, project management, monitoring, data management, biostatistics, medical writing, and regulatory consulting. Services offered as complete packages or modular components tailored to client needs.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

SocraTec R&D is a full-service Contract Research Organization (CRO) offering clinical trial services from Phase I through Phase IV for pharmaceutical and biotech sponsors. Services include trial design, project management, monitoring, data management (via subsidiary SocraMetrics), biostatistics, medical writing, quality assurance, and regulatory/scientific advice, delivered either as complete packages or modular components. The company operates its own 54-60 bed Clinical Pharmacology Unit in Erfurt with a 6-bed intensive monitoring unit at Helios Klinikum Erfurt for first-in-human and early-phase patient studies.

Product overview

SocraTec R&D is a full-service Contract Research Organization (CRO) providing comprehensive clinical research services from early-phase trials (Phase I) through later phases (Phase II-IV) and non-interventional studies. Their core offerings are organized as modular service packages that can be provided as full-service solutions or individual modules. The company operates their own 60-bed Clinical Pharmacology Unit in Erfurt with 6 intensive monitoring beds. Their portfolio includes specialized therapeutic expertise areas (oncology, ophthalmology, gynaecology, pediatrics, transdermal systems, inhalatives), bioequivalence/bioavailability studies, pharmacokinetic analysis using Phoenix WinNonlin®, drug interaction studies, medical writing, clinical monitoring, data management via subsidiary SocraMetrics (CDISC-compliant), biostatistics, quality assurance, and GCP training courses. The subsidiary SocraMetrics handles data management, biometrics, statistics, IT and EDC services.

Differentiator

Problem solved

Functional benefit

Products and services

• Early Phase Clinical Trials (Phase I)
• Phase II / Proof of Concept Trials
• Phase III Clinical Trials
• Phase III in OTC
• Non-Interventional Studies
• Medical Devices Clinical Trials
• Nutrition Studies
• Biosimilars PK Studies
• Bioavailability/Bioequivalence Studies
• Pharmacokinetic Analysis
• Drug Interaction Studies
• Oncological Trials
• Ophthalmological Trials
• Inhalative Drug Trials
• Transdermal Therapeutic Systems Trials
• Pediatric Clinical Trials
• Gynaecological Trials
• Design Development
• Scientific Advice
• Project Management
• Quality Assurance
• Clinical Monitoring
• Clinical Performance
• Data Management / eTrials
• Biostatistics
• Medical Writing
• Expert Statement
• GCP Courses
• Clinical Pharmacology Unit (CPU) Services

Quantifiable outcome

• 26 days for regulatory and ethics approval in mono-national German studies
• +3 more outcomes

Named customers2 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• Helios Klinikum ErfurtcoreStrategic or Co-development Partner · 1 January 2021Cooperation with maximum care hospital (58,000 patients/year) for second Clinical Pharmacology Unit. SocraTec provides scientific expertise and coordinating oversight while Helios contributes medical expertise across 30+ specialties. Enables FIH trials with highest safety standards and complex early-phase patient trials.
• SocraMetrics GmbHcoreStrategic or Co-development Partner · 1 January 2007Founded in 2007 by SocraTec founders and Frank Donath to provide state-of-the-art data management, pharmacokinetics, and statistical evaluation. CDISC-compliant with SDTMIG standard and CDASH-based, validated IT system per CFR 21 Part 11.
• dinoxminorStrategic or Co-development PartnerPartnership for endometriosis research capabilities. Combined expertise enables clinical trials from first-in-human through pivotal efficacy trials for endometriosis in early and late-stage development.
• Zentrum für Klinische Studien des Universitätsklinikums JenaminorStrategic or Co-development PartnerCollaboration for GCP training courses and continuing education for investigators, study team members, and clinical research personnel.
• Landesärztekammer ThüringenminorStrategic or Co-development PartnerCollaboration for GCP training courses and continuing education for medical professionals involved in clinical trials.
• Physikalisch-Technische Bundesanstalt (PTB) BerlinminorStrategic or Co-development PartnerAdditional CPU established in 2006 within PTB for gastrointestinal imaging studies using Magnetic Marker Monitoring technique.
• Global Bioequivalence Harmonisation Initiative (GBHI)coreStrategic or Co-development PartnerActive participation in EUFEPS/PQRI/AAPS organized GBHI conferences contributing to international bioequivalence harmonization efforts and guideline development.
• SocraTec C&S (Consulting)coreStrategic or Co-development PartnerThe consulting company SocraTec C&S provides independent consultancy services complementing the CRO portfolio, supporting scientific advice, protocol assistance, and regulatory consultations.

Scale indicators6 records

Recent moves10 records

Expansion highlights5 records

Market position

Competitive moat5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/socratec-r-d
• Xx.com/SocraTec
• Facebookfacebook.com/socratec.probandenstation

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 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 SocraTec R&D