Drug Safety Research Unit

What Drug Safety Research Unit does

Drug Safety Research Unit (DSRU) is an independent academic unit and registered UK charity (No. 327206) founded in 1981, headquartered at Bursledon Hall in Southampton. It operates as an Associate Department of the University of Portsmouth's School of Pharmacy and Biomedical Sciences and conducts post-authorisation safety studies (PASS), pharmacoepidemiology research, and pharmacovigilance consulting for pharmaceutical companies of all sizes, NHS healthcare providers, and regulatory authorities including the MHRA and EMA. The organisation's core methodologies are Specialist Cohort Event Monitoring (SCEM) for hospital-based and specialist-care PASS studies and Modified Prescription Event Monitoring (M-PEM) for primary care studies, with access to CPRD real-world data covering 16 million UK patients. Over 120 drug safety studies have been completed, with all proposals accepted by EU regulatory authorities with little or no modifications.

DSRU generates revenue through three lines: contract research services (PASS studies, drug utilisation studies, registries, benefit-risk assessments, systematic reviews), consulting (pharmacovigilance, pharmacoepidemiology, and bespoke packages for smaller pharma companies), and education and training (CPD-accredited pharmacovigilance courses delivered online, PMST specialty training with the Faculty of Pharmaceutical Medicine, and biennial conferences). Distribution is direct sales-led, targeting enterprise pharma clients and NHS networks, with European expansion enabled through the SIGMA Consortium and VAC4EU networks. The organisation is supported by an academic affiliation, an independent International Working Group of 20+ member organisations, and a Centre for Pharmacovigilance Sciences launched in March 2022 to advance methodological research.

The team comprises 11-50 staff, including a Director (Dr Linda Härmark, appointed 22 April 2025), a Chief Medical Officer, Heads of Epidemiology, Education and Training, and Scientific Development, plus clinical and research fellows. The not-for-profit structure, charity governance, and academic affiliation differentiate DSRU from commercial CROs, supporting its positioning as an independent scientific authority rather than a profit-maximising vendor.

Name

Drug Safety Research Unit

Legal name

Drug Safety Research Unit

Website

https://dsru.org

Company type

Private

Founded year

1981

Operating status

Operating

Headcount range

11–50 employees

Short description

Drug Safety Research Unit (DSRU) is an independent UK academic unit and registered charity, founded in 1981, that conducts post-authorisation safety studies, pharmacoepidemiology research, and pharmacovigilance consulting and training for pharmaceutical companies, NHS providers, and regulators.

Ownership category

akta.pro rank

Product category

Pharmacovigilance & Pharmacoepidemiology Research Services

NAICS

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

SIC

Services-Commercial Physical & Biological Research (8731), Services-Health Services (8000)

akta.pro industry

PRIMARYHLAGALAH

Medical Review & Pharmacovigilance Quality (PV QA/Audits/SOPs)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Pharmacovigilance & Medical Affairs Services

SECONDARYHLAGAOAF

Pharmacovigilance, Drug Safety & Risk Management FSP

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Scientific Staffing & Functional Service Providers (FSP)

SECONDARYHLAGAKAH

Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Regulatory Affairs, Quality & Compliance Services (GxP)

Keywords

• Pharmacovigilance research
• Post-authorization safety studies
• Pharmacoepidemiology consulting
• Drug safety studies
• Pharmacovigilance training

Headquarters

HQ city

Southampton

HQ country

United Kingdom

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Consulting Services: Pharmacoepidemiology and pharmacovigilance consulting services provided to pharmaceutical companies for study design, regulatory compliance, risk management planning, and observational study execution.
2. Education and Training: CPD-accredited pharmacovigilance and pharmacoepidemiology courses delivered online. Leading provider of pharmacovigilance training in Europe with courses suitable for all levels from beginners to experienced professionals.
3. Research Studies: Contract research services conducting PASS studies, drug utilisation studies, registries, benefit-risk assessments, and systematic reviews for pharmaceutical clients and regulatory requirements.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels7 records

Core offering

Drug Safety Research Unit (DSRU) is an independent academic unit and registered charity that conducts pharmacovigilance and pharmacoepidemiology research, including post-authorisation safety studies (PASS), event monitoring studies (SCEM and M-PEM), drug utilisation studies, registries, and CPRD-based real-world data studies. It also delivers consulting in pharmacovigilance and pharmacoepidemiology to pharmaceutical companies (including bespoke support for smaller firms) and CPD-accredited education and training courses in pharmacovigilance, risk management, and benefit-risk evaluation.

Product overview

The Drug Safety Research Unit (DSRU) is a service-based organisation providing pharmacovigilance and pharmacoepidemiology research, consulting, and education services. Its core offerings include Post-authorisation Safety Studies (PASS), Event Monitoring Studies (using SCEM and M-PEM methodologies), CPRD Studies, Drug Utilisation Studies, Risk Minimisation Services, Registries, Flu Vaccine Studies, Benefit-Risk Assessments, and Systematic Reviews. These services are delivered alongside consulting offerings in pharmacovigilance, pharmacoepidemiology, and specialised consulting for smaller companies. DSRU participates in European research networks (SIGMA Consortium and VAC4EU) and houses the Centre for Pharmacovigilance Sciences with its International Working Group and Global Pharmacovigilance Observatory. Education services include short courses, PMST training, and conferences. The organisation does not offer a software product but rather provides research and consulting services to pharmaceutical companies and healthcare organisations.

Differentiator

Problem solved

Functional benefit

Brands

• Centre for Pharmacovigilance Sciences: Established to advance methodological research in pharmacovigilance and pharmacoepidemiology
• DSRU International Working Group on New Developments in Pharmacovigilance
• DSRU Global Pharmacovigilance Observatory

Products and services

• Post-authorisation Safety Studies (PASS) Studies conducted on authorised medicinal products to identify, characterise, or quantify safety hazards, confirm safety profiles, and measure effectiveness of risk management measures, delivered to pharmaceutical companies and regulatory bodies.
• Event Monitoring Studies (SCEM & M-PEM) Hospital-based PASS studies using Specialist Cohort Event Monitoring (SCEM) methodology and primary care PASS studies using Modified Prescription Event Monitoring (M-PEM) methodology for post-authorisation safety surveillance.
• Drug Utilisation Studies Studies examining the distribution and use of drugs in real-world settings to determine how medicines are prescribed and used compared with intended use.
• CPRD Studies Studies using real-world data from the Clinical Practice Research Datalink (CPRD), the NHS observational data service, to investigate pharmacovigilance and pharmacoepidemiology research questions.
• Risk Minimisation Services Advisory and implementation services for additional risk minimisation measures and monitoring of the effectiveness of risk minimisation activities, including routine and additional measures per GVP Module XVI.
• Registries (Disease, Product, Pregnancy Exposure) Organised systems using observational study methods to collect uniform data to evaluate specified outcomes for populations defined by particular diseases, conditions, or exposures.
• Flu Vaccine Studies Active or passive enhanced safety surveillance studies on seasonal flu vaccines conducted annually per EMA interim guidance requirements.
• Benefit-Risk Assessment Assessments weighing benefits of specific treatments with risks, using systematic methodologies including the BRAT framework to support regulatory decision-making.
• Systematic Reviews Comprehensive literature reviews offering evidence-based overviews of health topics used to inform drug safety decisions, including meta-analysis when appropriate.
• Pharmacovigilance Consulting Expert consultancy covering regulatory enquiries, benefit/risk evaluations, additional risk minimisation measure proposals, PASS study suggestions, medical writing, and in-house training for pharmaceutical clients.
• Pharmacoepidemiology Consulting Advisory and support services covering all stages of pharmacoepidemiological study design and conduct, including non-interventional observational studies and self-controlled designs.
• Consulting for Smaller Companies Bespoke pharmacoepidemiology consulting services tailored for small to medium pharmaceutical companies lacking in-house expertise, including planning and conducting observational studies.
• Education & Training Courses Pharmacovigilance and pharmacoepidemiology training courses delivered online, covering beginner to advanced topics including Global Pharmacovigilance Regulatory Requirements, Risk Management, and AI in Pharmacovigilance. DSRU is described as a leading provider of pharmacovigilance training in Europe.
• Pharmaceutical Medicine Specialty Training (PMST) Specialty training for pharmaceutical physicians delivered in collaboration with the Faculty of Pharmaceutical Medicine (FPM), including FPM-accredited courses in pharmacovigilance, risk management and benefit-risk evaluation.

Quantifiable outcome

• All proposals accepted by EU regulatory authorities with little or no modifications
• +2 more outcomes

Named customers4 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

Feature3 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• SIGMA Consortium (part of ENCePP)coreStrategic or Co-development Partner · 1 January 2020The SIGMA Consortium was established by ENCePP (European Network of Centres for Pharmacoepidemiology & Pharmacovigilance) in 2020. DSRU joined as a member to integrate expertise and data from multiple European countries for multi-country real-world evidence research. The consortium comprises 15 leading research organisations across Europe providing state-of-the-art methodological pharmacoepidemiology and RWE research services.
• VAC4EU (Vaccine monitoring collaboration for Europe)coreStrategic or Co-development PartnerVAC4EU is a not-for-profit international association of 28 members forming a public study network for monitoring vaccine safety and effectiveness. DSRU joined during the COVID-19 pandemic and has conducted more than 10 vaccine safety studies through the network. The network has 14 data sources providing real-world data for regulatory-grade vaccine studies.
• CPRD (Clinical Practice Research Datalink)coreTechnology or IntegrationDSRU uses CPRD data from the NHS observational data service for pharmacoepidemiology studies. CPRD provides electronic primary healthcare records of 16 million active patients representative of the UK population. DSRU accesses both CPRD Aurum and Gold databases.
• NIHR CRN (National Institute for Health Research Clinical Research Network)coreStrategic or Co-development PartnerDSRU collaborates with NIHR CRN and other networks across the UK to identify hospital-based prescribers in relevant specialities for patient recruitment into PASS studies. This collaboration enables access to secondary care prescribing data.
• St George's Medical School, LondonminorStrategic or Co-development PartnerCollaboration with St George's Medical School, London on the DARE (Drug-induced Arrhythmia Risk Evaluation) study, funded by the British Heart Foundation. The study used a prospective case-control design to record and characterise drug-induced arrhythmia cases.
• Faculty of Pharmaceutical Medicine (FPM)coreStrategic or Co-development PartnerDSRU has worked with FPM for many years to deliver training in Pharmacovigilance, Risk Management and Benefit-Risk Evaluation for Pharmaceutical Medicine Specialty Training (PMST). Three courses are accredited by FPM.
• University of PortsmouthcoreStrategic or Co-development PartnerDSRU is an Associate Department of the School of Pharmacy and Biomedical Sciences, University of Portsmouth. This academic affiliation provides research collaboration opportunities and academic credibility.
• MEMO Research, University of DundeecoreStrategic or Co-development PartnerDSRU formed a consortium with MEMO Research, University of Dundee to monitor safety and effectiveness of COVID-19 vaccines. This consortium led to the 'One Million Study' for post-authorisation vaccine monitoring.

Scale indicators4 records

Recent moves9 records

Expansion highlights6 records

Broad incumbents

• IQVIA: Global full-service CRO with a substantial pharmacovigilance, real-world evidence, and pharmacoepidemiology practice. Overlaps with DSRU on PASS design and execution but typically bundled with broader clinical and commercial engagements.
• Parexel International: Major global CRO offering pharmacovigilance, regulatory, and real-world evidence services. Competes with DSRU particularly on multi-region PASS and risk management programmes for large pharma.
• ICON plc: Global CRO with dedicated pharmacovigilance and outcomes research capabilities. Comparable to DSRU on post-marketing safety studies but at much greater scale and geographic reach.

Direct peers

• Evidera: Pharmacoepidemiology and real-world evidence research organisation (now part of PPD/Thermo Fisher). Direct competitor on observational study design, PASS execution, and benefit-risk assessments using large healthcare datasets.
• PharSafer: UK-based pharmacovigilance specialist providing QPPV services, safety database hosting, and drug safety consulting. Comparable to DSRU's PV consulting arm, particularly in serving small-to-mid pharma clients.
• PrimeVigilance: Specialist pharmacovigilance and risk management CRO offering case processing, signal detection, and benefit-risk services to pharma. Closest direct competitor to DSRU's PV consulting and pharmacoepidemiology work, operating on a commercial (for-profit) basis.
• NDA Group: Independent regulatory and pharmacovigilance consulting firm with strong HTA and benefit-risk capabilities. Competes with DSRU on PV/regulatory consulting and advisory engagements for pharma clients.
• RTI Health Solutions: Specialist pharmacoepidemiology and health economics research consulting firm. Overlaps with DSRU on post-authorisation safety studies, drug utilisation research, and benefit-risk evaluations for pharma and regulators.

Emerging players

• Oxford PharmaGenesis: Independent healthcare communications and PV consultancy with a strong publications and real-world evidence focus. Comparable to DSRU on evidence dissemination, scientific communications, and serving pharma on PV-related content.

Others

• Faculty of Pharmaceutical Medicine (FPM): UK professional body accrediting pharmaceutical medicine specialty training. DSRU partners with FPM to deliver PMST-accredited PV courses; relevant as a training/standards peer rather than a commercial competitor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/DSRUDrugSafety
• LinkedInlinkedin.com/company/about
• Instagraminstagram.com/drugsafetyresearchunit
• Facebookfacebook.com/DrugSafetyResearchUnit

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Funding overview

Funding rounds

Investors

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Drug Safety Research Unit