Evidence for better decisions in healthcare

Our mission is to provide end-to-end, high-quality real-world evidence from Germany and beyond that enables sustainable and informed decisions in healthcare.

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PHARGO Health is an independent research institute and scientific consultancy to companies in the life-science sector with a focus on real-world evidence.

We support national and international partners from pharma, med-tech, healthcare and academia in making the right evidence based decisions.

Niklas Schmedt, DrPH

Dr. Niklas Schmedt brings more than 15 years of experience in Real World Evidence and pharmacoepidemiology in Germany, including seven years in the pharmaceutical industry. He is the Founder and Managing Director of PHARGO Health Institute GmbH.

Solving the evidence trilemma

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Scientific Excellence

Our senior driven approach ensures deep scientific expertise and the ability to apply innovative, complex study designs. With a holistic evidence perspective, we ensure that every project meets the highest methodological standards and delivers insights that truly matter for clinical, regulatory and economic decision making.

Business-Driven Approach

We think scientifically and act strategically. Our work is shaped by close partnership with our clients, a clear understanding of stakeholder needs and a focus on solutions that create real world impact for products, portfolios and healthcare systems.

Speed

We deliver high quality and targeted evidence fast. Through fit for purpose methodologies and flexible execution, we provide timely results without compromising scientific rigor.

Our Services

Science-Driven Solutions for Better Decisions

Generating meaningful evidence requires more than data. It takes scientific rigor, methodological expertise and a clear understanding of what clinicians, regulators, payers and decision makers need. We support pharmaceutical and biotech companies throughout the entire product lifecycle, from early clinical development to market access and post-launch.

Our services combine strategic evidence planning, real-world data analyses, systematic evidence synthesis, scientific communication and pharmacovigilance expertise. Whether you need a comprehensive evidence strategy, a targeted analysis or fast answers to time-critical questions, we provide tailored solutions built on the highest scientific standards.

Scientific Consulting & Integrated Evidence Planning

We support our clients with rigorous scientific consulting and the development of ambitious, cross-functional integrated evidence plans. Our focus is methodological excellence, strategic relevance and alignment with clinical, regulatory and health economic requirements.

Integrated Evidence Planning Cross-functional evidence strategies from early phase II to post-launch, considering the needs of all relevant stakeholders

Methodological Consulting for RWE Projects Database selection, study design, epidemiological and statistical methods

Critical Appraisals of RWE Publications Quality assessment of publications related to your product or a competitor, incl. response strategy

Statistical Consulting for AMNOG Benefit Assessment Support for statistical questions in the context of the “early benefit assessment” in Germany

Educational Sessions Workshops on epi methods and RWE use cases

Real World Evidence (RWE)

We generate robust, methodologically rigorous real-world evidence in Germany, based on statutory claims data or licensed datasets to support strategic decisions for our clients. Our analyses deliver reliable insights for clinical, economic and business questions reflecting current clinical practice.

Comparative Effectiveness & Safety — Comparative analyses of the effectiveness and safety of therapeutic regimens under real-world conditions, conducted according to the highest scientific standards (target trial emulation).

Epidemiological Analyses on Unmet Need & Burden of Illness — Quantification of disease burden, care gaps, and patient-relevant outcomes.

Cost of Care & Healthcare Resource Use — Detailed evaluations of cost structures, resource utilization, and economic implications.

Natural History of Disease — Characterization of the natural course of disease to support clinical and regulatory decision-making.

Drug Utilization Studies (e.g., Adherence and Persistence) — Real-world analyses of current treatment patterns, adherence, persistence, and long-term outcomes.

External Control Arms for Direct or Indirect Treatment Comparisons — Development of RWD-based comparator cohorts for direct or indirect comparisons or supplementary evidence in clinical development programs.

Exploratory Analyses for Strategic Business Insights — Deep and targeted data driven insights into patient journeys, prescribing trends, patient characteristics, and real world care patterns to inform strategic decision making

Evidence Synthesis

We identify, evaluate and synthesize scientific evidence systematically, transparently and — if desired — AI-supported. Our evidence syntheses provide reliable foundations for clinical development, market access, medical affairs and regulatory decision-making.

Systematic Literature Reviews — Comprehensive, methodologically robust literature searches following international standards.

Targeted Literature Reviews — Focused, purpose-driven evidence searches for specific research questions.

Rapid Reviews & Rapid Assessments — Accelerated evidence syntheses for time-critical projects.

Meta-Analyses & Indirect Treatment Comparisons — Quantitative evidence integration, including network meta-analyses and matching-adjusted indirect comparisons.

Scientific Communication & Dissemination

We prepare scientific results precisely, effectively and tailored to the target audience. Our goal is to communicate complex content scientifically sound and with impact — for scientific, regulatory and strategic purposes.

Scientific Publications and Conference Contributions — Development of manuscripts, abstracts, posters and presentations for journals and scientific congresses.

Medical Writing for Regulatory Purposes — Preparation of key sections of regulatory documents, including Periodic Safety Update Reports (PSUR, PBRER), Risk Management Plans, Development Safety Update Reports (DSUR), Orphan Designation Dossiers and Pediatric Investigation Plans (PIP).

Pharmacovigilance & Regulatory Affairs

We provide expert consulting in pharmacovigilance and regulatory requirements. Our focus is on planning, evaluating and conducting Post-Authorization Safety Studies as well as rapid, evidence-based signal assessments. We combine methodological excellence with deep understanding of regulatory processes.

Methodological Consulting for Post-Authorization Safety Studies (PASS) — Support in study design, data source landscaping, statistical methods and regulatory interactions (e.g., type II variations).

Rapid Signal Assessments Based on Real-World Data — Fast, reliable analyses using German claims data, including background incidence estimation and characterization of affected patient groups.

Rapid Literature Assessments — Timely literature reviews to evaluate potential safety risks (AI-supported on request).

Analysis of Spontaneous Reporting Databases — Evaluation of international databases such as FAERS, EudraVigilance or VigiAccess to identify and assess safety signals.

Have a question? Find answer here

Get quick answers about working with us and our approach to evidence generation. Can’t find what you are looking for? Reach out below.

01. What data sources does PHARGO Health use?

We primarily work with German statutory health insurance claims data, which cover a large and representative share of the German population. These data enable longitudinal analyses of diagnoses, prescriptions, hospitalizations, and healthcare costs.

Depending on the research question, we also integrate licensed datasets and international spontaneous reporting systems, including FAERS, EudraVigilance, and VigiAccess.

During an initial scoping call, we jointly assess which data source can reliably answer your question.

02. How long does a typical project take?

Project duration depends on the scope and complexity of the work. We understand that speed is critical for our clients, and we tailor timelines accordingly.

Exploratory business insights analyses and rapid literature assessments are typically delivered within a few weeks after contract signature.

In contrast, a full systematic literature review or a comparative effectiveness study using claims data usually spans several months, including protocol development, data analysis, and reporting.

After an initial discussion of your needs, we provide a realistic and transparent timeline for your specific project.

03. How do you ensure the methodological quality of your analyses?

We ensure high methodological quality by adhering to established international standards for real-world evidence (RWE), pharmacoepidemiology, and evidence synthesis. Our work is grounded in widely recognized guidelines, including:

ISPE Good Pharmacoepidemiology Practices (GPP)
ENCePP Guide on Methodological Standards in Pharmacoepidemiology (EMA)
Target Trial Emulation principles for causal inference in observational data
PRISMA / PRISMA-S / PRISMA-R for systematic and rapid literature reviews
STROBE / RECORD for transparent reporting of observational researc

Before any analysis begins, we develop a fit-for-purpose analysis plan or study protocol, document all assumptions, and ensure that analytical decisions remain transparent and traceable throughout the project. We also ensure that all data are stored for the time period required for the respective project and in accordance with regulatory expectations.

This structured approach ensures that our analyses are robust, reproducible, and suitable for scrutiny by journal reviewers, HTA bodies, and regulatory authorities.

04. Do you use AI in your work?

Yes — where it adds value and if you request it. AI-supported screening can significantly accelerate literature reviews, especially in rapid assessments with tight timelines. It can also streamline the development of study protocols, analysis plans, and study reports.

Every AI-assisted step is human-supervised, fully documented, and validated against established methods to ensure methodological rigor.

Whether AI is used in your project is entirely up to you. Beforehand, we explain the trade-offs between speed and methodological convention transparently so you can make an informed decision.

05. At which stage of a project should we get in touch with PHARGO Health?

PHARGO Health provides end-to-end support across the entire evidence generation cycle — from early evidence planning to the communication and dissemination of results. You can reach out to us at any stage of your project.

To maximize impact and efficiency, we recommend involving us as early as possible, ideally during the evidence planning phase. Early alignment ensures that research questions, data sources, and methodological approaches are strategically coordinated from the start.

Evidence for better decisions in healthcare

PHARGO Health is an independent research institute and scientific consultancy to companies in the life-science sector with a focus on real-world evidence.

We support national and international partners from pharma, med-tech, healthcare and academia in making the right evidence based decisions.

Niklas Schmedt, DrPH

Dr. Niklas Schmedt brings more than 15 years of experience in Real World Evidence and pharmacoepidemiology in Germany, including seven years in the pharmaceutical industry. He is the Founder and Managing Director of PHARGO Health Institute GmbH.

Solving the evidence trilemma

Our Services

Science-Driven Solutions for Better Decisions

Have a question? Find answer here

Start your experience with PHARGO Health today.

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