FAQ

Medaffcon is a Nordic research and consulting company specializing in Real-World Evidence, Market Access, and Medical Affairs for the pharmaceutical, medtech, and healthcare industries.

We provide research and expert services across the Nordics and Europe, combining expertise in health economics, medicine, and data science.

Medaffcon has offices in Espoo, Finland and Stockholm, Sweden, and operates across the Nordic region including Finland, Sweden, Denmark, and Norway.

Our projects often span multiple Nordic countries, reflecting how companies in the industry increasingly approach the Nordics as an integrated market.

Medaffcon operates across the Nordic region and serves clients in the Nordics and Europe.

Our Nordic network of experts and research partners allows us to deliver Nordic-wide projects and services seamlessly across the region.

We mainly operate in Finland, Sweden, Denmark and Norway, and as a partner for international companies seeking to use Nordic healthcare data.

Our clients include pharmaceutical and medtech companies, as well as other healthcare organizations seeking evidence generation, market access support, or medical expertise.

Medaffcon works primarily with:

• Pharmaceutical companies
• Biotechnology companies
• Medical technology companies
• Healthcare organisations
• Research institutions

We collaborate closely with industry experts, healthcare providers, academic institutions, and research organisations to advance healthcare research and innovation.

1. Deep Nordic expertise

2. Strong RWE capability

3. The ability to combine medical, health economic, and data science perspectives in one partner.

We have one of the largest RWE teams in the Nordics and a wealth of hands-on experience with Nordic health data, reimbursement environments, and cross-functional pharma needs.

Medaffcon supports pharmaceutical and healthcare companies throughout the lifecycle of medicines and healthcare technologies. Medaffcon’s core services include Real-World Evidence, Market Access, and Medical Affairs.

Across these areas, we offer i.e. project-based consulting, evidence strategy and generation, health economic modelling, pricing and reimbursement support, stakeholder mapping, scientific communication, expert resourcing, and tailored training.

We support the full RWE process—from study design and data access to analysis and reporting—helping generate insights for decision-making, payer discussions, and publications.

Projects range from comprehensive, end-to-end RWE studies to streamlined “FastTrack” data requests designed for rapid insights.

Our services include:

• Registry-based studies
• Real-world data analysis
• Evidence generation strategy
• Data gap analysis and study design
• Scientific publications and communication

Our team combines medical expertise, epidemiology, health economics, and advanced data analytics to deliver high-quality research.

Real-world data is routinely collected health data, such as electronic health records, claims, and registries; when analyzed, it can generate real-world evidence on treatment patterns, outcomes, safety, disease burden, and healthcare resource use.

FDA and EMA both describe RWD/RWE as important for understanding how treatments perform in routine practice. Medaffcon uses RWE i.e. to support epidemiology, payer evidence, health economic analyses, and market access decision-making.

Medaffcon helps pharmaceutical and medtech companies demonstrate the value of their products to healthcare decision-makers and reimbursement authorities.

Market Access services include:

• Health economic modelling
• Pricing and reimbursement strategy
• Market analytics
• Value communication tools
• Risk-sharing agreements
• Market entry and lifecycle strategy

The goal is to help new treatments and technologies reach the right patients quickly and at an optimal price while addressing non-medical barriers such as reimbursement, budget impact, and payer evidence requirements.

Health economic modelling is a structured way to combine clinical, epidemiological, cost, and outcomes data to estimate the likely impact of a healthcare intervention.

Health economic modelling is a central tool for authorities, experts, and payers, especially for cost-effectiveness and budget impact analysis. Economic evaluation is a core part of reimbursement and assessment decisions.

Risk sharing agreements are arrangements between a manufacturer and payer that help manage uncertainty around a medicine’s budget impact, outcomes, or value after launch, often linking reimbursement to real-world performance.

In many systems they are discussed under the broader term managed entry agreements. NICE describes managed access as a way to allow temporary access while further evidence is collected.

Medaffcon provides expert support for such conditional reimbursement and contractual arrangements.

Medaffcon provides Medical Affairs support in areas such as literature reviews, scientific summaries, healthcare environment assessments, stakeholder mapping, expert meetings, marketing material reviews, training, and interim expert resourcing.

We can support both product launch preparation and lifecycle management projects.

Medical Affairs serves as the scientific bridge between R&D, commercial teams, healthcare professionals, and the wider healthcare ecosystem. Medical Affairs is responsible for scientific exchange, evidence communication, external engagement, and helping ensure that medical strategy remains evidence-based and ethically grounded.

Medaffcon’s scientific and strategic support for Medical Affairs organizations includes:

• Scientific communication
• Literature reviews
• Advisory boards and expert meetings
• Stakeholder mapping
• Medical training and coaching
• Interim Medical Affairs support

These services help ensure accurate scientific communication and strong stakeholder engagement.

Medaffcon offers flexible outsourcing and expert resourcing solutions to support pharmaceutical and healthcare organizations across Market Access, Medical Affairs, and marketing functions. We provide experienced professionals who can seamlessly integrate into your team on a temporary, project-based, or longer-term basis—depending on your needs.

Our network includes roles such as Medical Science Liaisons, Medical Advisors, Market Access Managers, Health Economists, Scientific Project Managers, and marketing support specialists. In addition, we support activities like literature reviews, scientific communication, stakeholder engagement, and marketing-related deliverables.

We manage the full outsourcing process—from identifying the right expert to handling recruitment, employment, and administration—ensuring a smooth and efficient experience. This allows you to quickly access the right expertise, scale resources as needed, and stay focused on your core business.

Medaffcon offers tailored training and coaching programs in areas such as health economics, reimbursement and market access practices, compliance, and the use of real-world evidence.

The trainings are customized with the client in advance and can be delivered in Finnish, Swedish or English.

Nordic healthcare registries are large, routinely collected datasets maintained by public authorities and healthcare systems, covering areas such as hospital care, prescriptions, cancer, births, causes of death, and population data.

The Nordic registries are population-based, longitudinal, and often linkable at individual level under strict legal controls.

The Nordics are especially valuable for healthcare research because they combine universal healthcare systems, high-quality registries, long follow-up periods, and strong public data infrastructure. This creates a unique environment for healthcare research, with broad coverage, prospective data collection, and strong possibilities for longitudinal and comparative studies.

Together, the Nordic countries represent a population of around 27 million people, creating valuable datasets for real-world research.

Real-World Data is data about patient health or healthcare delivery that is routinely collected outside traditional randomized clinical trials.

FDA defines RWD as data relating to patient health status and/or the delivery of healthcare routinely collected from sources such as EHRs, claims, and registries; EMA likewise points to observational data stored in sources like electronic health records and disease registries.

Examples include:

• National health registries
• Electronic health records
• Prescription databases
• Insurance claims data

This data can be analyzed to generate Real-World Evidence that helps evaluate treatment outcomes and healthcare utilization.

Real-World Evidence is the clinical or decision-relevant evidence generated by analyzing real-world data.

In practice, it is used to understand how treatments perform in actual care settings, including effectiveness, safety, treatment pathways, healthcare utilization, and outcomes in broader patient populations than those typically studied in trials.

RWE can be used i.e. to support epidemiology, burden-of-disease research, payer evidence, post-launch effectiveness assessment, safety monitoring, health economic modelling, and market access planning.

Real-World Evidence studies help answer important questions such as:

• How treatments perform in clinical practice
• Treatment patterns and patient pathways
• Disease burden and healthcare resource use
• Cost-effectiveness of therapies

These insights support regulatory decisions, payer discussions, and clinical strategy.

Companies typically benefit from an RWE consultancy when they need robust real-world insights for launch planning, payer discussions, epidemiology, post-launch evidence generation, treatment pathway analysis, or health economic inputs. This is especially useful when internal teams need Nordic data expertise, fast access to local evidence planning, or support navigating data access and study execution across countries.

Companies typically involve Real-World Evidence experts when they need to generate evidence to support:

• Market access and reimbursement
• Clinical development strategy
• Post-marketing studies
• Treatment outcome research
• Health economic evaluations

External expertise helps ensure studies are scientifically robust and aligned with regulatory and payer expectations.

A Market Access consultancy is particularly valuable before launch, during pricing and reimbursement planning, when preparing value dossiers, or when addressing uncertainty through modelling and managed access arrangements.

In Finland, for example, reimbursement status and a reasonable wholesale price are confirmed by the Pharmaceuticals Pricing Board, making local process expertise important for successful access planning.

Medical Affairs support is useful when a company needs scientific communication, literature synthesis, healthcare environment mapping, stakeholder engagement, training, launch readiness support, or temporary expert capacity.

The need often arises both before launch and during lifecycle management, especially when teams need specialized expertise quickly.

For general inquiries, info@medaffcon.com.

For service-specific discussions:

• Real-World Evidence: Mariann Lassenius, +358 50 345 2393, mariann.lassenius@medaffcon.com
• Medical Affairs: Kristiina Pelli, +358 40 510 0838, kristiina.pelli@medaffcon.com
• Market Access: Simo Jääskeläinen, +358 40 580 0567, simo.jaaskelainen@medaffcon.com