Request a proposal Privacy policy

Real-world evidence services

Real-world evidence studies

Registries, post-authorization safety and effectiveness studies, and real-world data research in neuroscience, infectious diseases and vaccines, and cardiometabolic diseases.

Regulatory-grade evidence doesn’t stop at approval.

Meet our experts

Epidemiology CRO services

The right question. The right data. Evidence that holds up.

Regulators ask hard questions. So do payers, clinicians, and patients. AKEURA’s answers are built by epidemiologists, not adapted from a clinical model.

Real-world evidence is only as strong as the study design, data source, and analysis behind it, so our epidemiologists make those choices from the start. Patient registries, real-world data research, pragmatic studies, and external control arms all start there.

Epidemiology, statistics and modeling, systematic reviews, and medical writing stay connected from first question to final evidence. Our RWE specialists work on their own or alongside your clinical development team, with one seamless handover from first dose to real-world use.

Explore our expertise

You’re covered for every phase

A smooth, continuous journey from clinical to real-world settings

Real-world evidence takes tenacity, and we have plenty

Studies designed by epidemiologists, across neuroscience, infectious diseases and vaccines, and cardiometabolic diseases.

  • 400+

    RWE projects, from registries to PASS

  • 145+

    vaccine RWE studies, a core specialty

  • 340k+

    participants in real-world studies

  • 45+

    countries reached with real-world data

Real-world evidence across our therapeutic areas

Neuroscience

Some of the hardest indications in medicine, run by people who have spent their careers in them. We know the endpoints, the raters and the sites that actually deliver.

140+ studies Learn more

Infectious diseases and vaccines

Respiratory and tropical infections, antimicrobial resistance, and global vaccine studies, run by teams on the ground where infectious diseases circulate. We read the epidemiology before we write the protocol.

400+ studies Learn more

Cardiometabolic diseases

Event-driven outcomes trials and the tough-to-recruit metabolic indications: obesity, diabetes, MASH, and lipid disorders. We keep the participants we recruit.

100+ studies Learn more

Six things that can go wrong in RWE, and how we approach them

These are the calls we get most, and none of them scare us.

Experience means we see problems coming. Tenacity gets you through the ones that arrive anyway.

1

The data source doesn’t fit the question.

Our approach

Our epidemiologists choose the source to fit the question, never the other way around.

To estimate the burden of RSV, we built one model-based database study across eight countries on four continents.

2

The design gets questioned after the data is in.

Our approach

PASS and PAES designs are planned before approval, by people who have delivered them, and built for regulatory review from the first draft.

3

Every country records it differently.

Our approach

European data partnerships and local knowledge keep the analysis consistent across borders.

Our pneumococcal vaccine effectiveness research combines surveillance and serotyping data from Czechia, Israel, and Spain.

4

There’s no control group to compare against.

Our approach

We build external control arms from systematic literature review, meta-analysis, and real-world data.

For one complex single-arm program, we screened 7,000+ articles and drew on 2,200+ patients across Europe and North America.

5

The impact is real, but hard to prove.

Our approach

We use quasi-experimental designs on linked real-world data to separate the effect from the noise.

A controlled interrupted time-series study on linked surveillance data from Brazil measured the real-world impact of a dengue vaccine on hospitalizations.

6

The team that wins the bid isn’t the team that writes the report.

Our approach

Not here.

The expert who writes your protocol signs off your final report. Same name, same number, start to finish.

Local data at global standards. No weak links.

Choosing the right data source is one of the decisions that makes or breaks a multi-database study.

Our European data partnerships and local knowledge match each question to the right sources, account for country context, and keep the analysis consistent across borders.

Through id.DRIVE, a European public-private partnership formerly known as COVIDRIVE, our epidemiologists study the burden of infectious diseases and the real-world effectiveness of vaccines and other interventions.

With ARWEN ID, an international infectious disease observatory built with LOGEX on hospital data, we track COVID-19, RSV, influenza, and other infections, and the impact of vaccines.

Every study run by the people you chose

Meet the epidemiologists and RWE specialists behind your evidence.

Talk to a real-world evidence expert
Kaatje Bollaerts

Kaatje Bollaerts

Senior Vice President, Real-World Evidence

20+ years in vaccine and infectious disease biostatistics, now leading global real-world evidence research and partnerships.

Elisabeth (Lisanne) Mesfun-Kap, MSc

Elisabeth (Lisanne) Mesfun-Kap, MSc

Head of Epidemiology

7+ years of real-world evidence across oncology, heart failure, and liver disease, now leading epidemiological study design for vaccine research.

Margarita Riera, MD, MSc

Margarita Riera, MD, MSc

Strategy Director, Real-World Evidence

Field medicine and epidemiology across Africa and Asia, now shaping real-world evidence strategy for vaccine research.

Aleksandra Polkowska-Kramek, PhD

Aleksandra Polkowska-Kramek, PhD

Program Head, Epidemiology

Leading infectious disease and vaccine evidence programs, backed by 10+ years of epidemiology and public health work.

Omar Okasha, MD, MPH

Omar Okasha, MD, MPH

Epidemiologist

Leading real-world studies of vaccine impact, effectiveness, and safety, backed by 20+ years as a physician-epidemiologist.

Real-world evidence CRO services

What we deliver in real-world evidence

  • Epidemiology and study design
  • Post-authorization studies (PASS and PAES)
  • Patient registries and observational studies
  • Database and EHR analysis
  • Systematic literature reviews and meta-analysis
  • Burden of disease and health economics
  • Vaccine effectiveness studies
  • Safety surveillance and pharmacovigilance
  • External control arms

When your program needs a clinical trial

Early and late phase clinical development specialists, working alongside your real-world evidence team or on their own.

Early phase clinical development

Confident first steps from first dose to proof of concept, with answers your next study can trust

Explore early phase

Late phase clinical development

Phase IIb to Phase IV trials at scale, built to carry your program through approval and beyond

Explore late phase

Frequently asked questions

Answers to your questions about real-world evidence

Real-world data are routinely collected health data, including electronic health records, claims, registries, and surveillance data. Real-world evidence is the clinical evidence generated by analyzing those data to answer questions about treatment use, safety, effectiveness, and outcomes.

We conduct patient registries, observational and database studies, pragmatic studies, external control arms, PASS, PAES, vaccine effectiveness and safety studies, burden-of-disease research, and systematic literature reviews.

Before approval, real-world evidence can test study feasibility, identify patient populations, inform endpoint and comparator strategies, and support external control arms in real-world patient populations. AKEURA’s RWE and clinical development teams can work together or independently from the start.

Yes. Real-world evidence can support regulatory submissions, post-authorization safety and effectiveness requirements, label expansion, pharmacovigilance, and long-term benefit-risk assessment. The study design and data must fit the question and intended use.

Depending on the question, a study may use electronic health records, medical claims, patient or disease registries, surveillance systems, chart review data, linked databases, and other routinely collected health data. AKEURA selects diverse sources tailored to clinical relevance, coverage, and purpose based on your study’s unique needs.

An external control arm uses patient data collected outside the current trial to provide a comparator for a treatment group. It can be useful when randomization is difficult or inappropriate, including in cancer, certain rare diseases, and in single-arm studies.

Look for epidemiology leadership, fit-for-purpose data selection, experience with the study design and geography you need, transparent methods, and direct access to the experts doing the work. AKEURA’s RWE studies are led by epidemiologists, with 400+ RWE projects behind them, including 250+ full-service studies.

Yes. AKEURA designs and runs patient and disease registries, including long-term registries that support post-authorization safety and effectiveness commitments. Our teams keep sites and participants engaged across years of follow-up.

Connect with an expert

Tell us what you need.
Your message goes to the team that handles your study.

Name
Kaatje Bollaerts

Kaatje Bollaerts

Senior Vice President, Real-World Evidence

20+ years in vaccine and infectious disease biostatistics, now leading global real-world evidence research and partnerships.

Global headquarters

Nieuweroordweg 1,
3704 EC Zeist,
The Netherlands

+31 30 656 99 00

Weena 690,
Unit 26.18,
3012 CN Rotterdam,
The Netherlands