Sacura

What Sacura does

Sacura GmbH is a privately held full-service Contract Research Organization (CRO) headquartered in Münster, Germany, founded in 2012 and operating with 11–50 employees. The company provides end-to-end clinical trial services — consulting, project management, e-collaboration, and full study execution — to biotech companies, pharmaceutical firms, academic institutions, and medical device manufacturers across Europe, North America, and Asia. Sacura has executed more than 130 clinical trials spanning 85+ indications in 25+ countries and has been inspected by the FDA with no Form 483 observations, a quality credential the company prominently markets.

The firm's service portfolio is anchored by e.tract, a proprietary web-based collaboration and electronic Trial Master File (eTMF) platform developed jointly with OrbiTeam Software GmbH & Co. KG and built on OrbiTeam's BSCW groupware (originally a Fraunhofer FIT spin-off). e.tract provides document management with version control, role-based access, mobile collaboration, and 21 CFR Part 11 compliance, and is adapted to the DIA Trial Master File Reference Model. Sacura positions itself as a niche specialist in complex, "tricky" clinical trials, orphan drug programs, and rescue studies, drawing on a leadership team with 20+ years of clinical development experience across big pharma, biotech boards, and CRO/SMO operations.

Sacura monetizes through professional-services engagements (consulting, project management, study execution) priced on a quote basis, with no public pricing, recurring SaaS disclosure, or institutional funding. The firm is owned and operated by three partners — Gabriele Hartwig (deceased August 2025), Dietmar Rescheleit, and Frank Hartwig — with no parent company, subsidiaries, or external investment referenced. Go-to-market is enterprise direct sales augmented by participation in European life-sciences conferences (BIONNALE, BIO-Europe, GQMA Jahrestagung, BVMA Symposium, DMEA, Nordic Life Science Days, Deutsche Biotechnologietage, EUCROF, DGPharMed).

Name

Sacura

Legal name

Sacura GmbH

Website

https://sacura-cro.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

11–50 employees

Short description

Sacura GmbH is a privately held, full-service German Contract Research Organization (CRO) providing consulting, project management, eTMF collaboration via its e.tract platform, and full clinical study execution for biotech, pharma, academic, and medical device sponsors across 25+ countries.

Ownership category

akta.pro rank

Product category

Contract Research Organization / Clinical Trial Services

NAICS

Scientific Research and Development Services (5417), Professional, Scientific, and Technical Services (541)

SIC

Services-Commercial Physical & Biological Research (8731)

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)

SECONDARYHLAGAAAG

Medical Writing & Regulatory Submission Support CROs

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

SECONDARYHLAGAAAB

Preclinical CROs (Discovery/Pharmacology/DMPK)

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

SECONDARYHLAGAAAH

Pharmacovigilance, Risk Management & Medical Affairs CROs

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

Keywords

• Clinical trial services
• Contract research organization
• Electronic trial master file
• Biotech consulting
• Pharmaceutical research

Headquarters

HQ city

Münster

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Research Services: Full-service contract research organization providing comprehensive clinical trial services including consulting, project management, study execution, and e-collabortion solutions. Services cover the complete life cycle from Target Product Profile (TPP) to market access.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

Sacura is a full-service contract research organization (CRO) that plans, manages, and executes international clinical trials for biotech, pharmaceutical, academic, and medical device clients. Its offering spans consulting, project management, e-collaboration, and study execution services, anchored by its proprietary e.tract web-based eTMF and collaboration platform developed with OrbiTeam Software. The company covers the complete clinical development life cycle from Target Product Profile to market access, with particular emphasis on complex trials, orphan drug studies, and rescue studies.

Product overview

Sacura is a full-service Contract Research Organization (CRO) offering a portfolio of clinical trial services built around its core e.tract software platform. The offering combines consulting services (management consultancy, pre-clinical planning, crisis management), project management (planning, budgeting, quality assurance, risk management), the e.tract eTMF/collaboration platform, and full study execution services. The e.tract platform is a web-based solution developed with OrbiTeam Software, providing secure document collaboration, workspaces, and electronic Trial Master File functionality for clinical trial sponsors.

Differentiator

Problem solved

Functional benefit

Brands

• e.tract: A web-based online platform for secure collaboration of all partners in clinical trials. The software simplifies editing, sharing, tracking and archiving of study documents. Central domains include individually structured workspaces and an electronic Trial Master File (eTMF). Developed in cooperation with OrbiTeam Software based on their BSCW groupware platform.

Products and services

• e.tract Web-based online platform for secure collaboration of all partners in clinical trials, featuring individually structured workspaces and an electronic Trial Master File (eTMF). Enables sponsors to demonstrate compliance with Good Clinical Practice standards and regulatory requirements, with document version control, role-based access, mobile access, and CFR Part 11 compliance. Developed by Sacura and OrbiTeam Software based on the BSCW groupware platform; marketed to pharmaceutical and biotech clients.
• Consulting Services Management consultancy for clinical development programs for biotechs, academic institutions, and medical device companies. Includes late-stage pre-clinical development planning for first clinical studies, state-of-the-art support from a network of pharmaceutical industry veterans, one-stop-shop coverage from Target Product Profile to market access, and crisis management including rescue study expertise.
• Project Management Services Clinical trial project management covering project planning with compilation of management plans and key parameter definition (milestones, budgets, resources, logistics, project tools); project performance including budgeting, cost management, resource coordination, and third-party provider management; quality assurance; and risk management covering trial management, monitoring approach, and control.
• E-Collaboration Services Operational embedding of the e.tract collaboration and eTMF platform in study-related processes. Covers professional document management with version control, efficient teamwork and communication across time zones with integrated mobile access, project control and management workflows with role-based access, and data safety and traceability with CFR Part 11 compliance.
• Study Execution Services Complete study services including selection and evaluation of key opinion leaders and investigator coordination; planning and implementation (kick-off meetings, electronic systems implementation, supply of investigational product and materials); on-site support with GCP training, audits, and clinical quality assurance; reporting and submission to authorities; and on-site, centralized, and data monitoring.

Quantifiable outcome

• 130+ clinical trials completed successfully
• +2 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Five partnerships are on record, tiered minor and core.

• CONELIS (Competence Network Life Science)minorStrategic or Co-development Partner · 24 May 2013Sacura became a sustaining member of CONELIS e.V. on 24 May 2013. CONELIS is an association of selected life science experts covering the entire value chain from early discovery to product commercialization including Chemistry, Manufacturing and Control, Preclinical R&D, Clinical Development, Drug Regulatory Affairs, and Business Strategy.
• BIO DeutschlandminorStrategic or Co-development Partner · 25 April 2012Sacura joined BIO Deutschland (Biotechnologie-Industrie-Organisation Deutschland e.V.) on 25 April 2012. BIO Deutschland is the German association of the biotechnology industry with about 300 members. The organization works on political initiatives to improve legal parameters for innovative SMEs and represents Germany's biotechnology sector at EuropaBio.
• OrbiTeam Software GmbH & Co. KGcoreTechnology or IntegrationSacura and OrbiTeam developed the collaboration system 'e.tract' based on BSCW (an award-winning groupware platform). OrbiTeam is a spin-off of Fraunhofer Institute for Applied Information Technology (FIT), founded in 1998. The e.tract platform includes an eTMF adapted to Trial Master File Reference Model standards supported by the Document and Records Management SIAC of DIA.
• DGPharMed (German Society for Pharmaceutical Medicine)minorStrategic or Co-development PartnerThe German Society for Pharmaceutical Medicine (Deutsche Gesellschaft für Pharmazeutische Medizin) deals with investigation and development as well as security of pharmaceuticals and medical products, profiling pharmaceutical medicine through ensuring and developing standards, competence and ethical integrity.
• GQMA (German Quality Management Association e.V.)minorStrategic or Co-development PartnerGQMA was founded in 1995 and is Europe's second largest association dedicated to quality management in the chemical and pharmaceutical industries with more than 900 members. Members include quality assurance professionals, study directors, physicians, and monitors from industry, CROs, central labs, hospitals and government agencies.

Scale indicators4 records

Recent moves6 records

Expansion highlights4 records

Broad incumbents

• Parexel International: Global full-service clinical CRO serving large pharma and biotech; broad incumbent competitor in the same clinical trial services category.
• IQVIA: World's largest clinical CRO with end-to-end Phase I–IV services and proprietary eClinical platforms; broad incumbent Sacura competes against for biotech and pharma awards.

Direct peers

• KCR: European-headquartered mid-sized clinical CRO with full-service offerings for biotech and pharma across multiple therapeutic areas; comparable mid-tier European CRO profile.
• Worldwide Clinical Trials: Mid-sized global clinical CRO offering full-service Phase I–IV execution with biotech and mid-market pharma clients; comparable to Sacura in service scope and target customer profile.
• Medpace: US-headquartered, mid-sized full-service clinical CRO with strong biotech/small-pharma focus and proprietary technology platforms; a direct strategic analogue to Sacura's biotech-oriented, full-service model, though at materially larger scale.
• Ergomed: Mid-sized clinical CRO historically focused on orphan and complex indications for biotech; notable specialty overlap with Sacura's orphan/rescue positioning.
• Clinipace Worldwide: Mid-sized technology-enabled clinical CRO focused on small and mid-sized biotech and specialty indications; comparable mid-market full-service positioning to Sacura.
• FGK Clinical Research: Munich-based European full-service clinical CRO of similar size and headcount serving biotech, pharma, and medical device clients; the closest geographic and scale peer to Sacura.
• Advanced Clinical: Mid-sized full-service clinical CRO serving biotech, pharma, and medical device sponsors with focus on complex and niche studies; directly comparable in size and service mix.
• TFS International: Mid-sized European-based full-service and functional CRO with biotech and mid-market pharma customers; comparable scale, geography, and clinical service scope.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/SacuraCRO

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 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 Sacura