Glossary of terms
Plain-English definitions for the acronyms, methods and frameworks our teams actually use, written by people who file the dossiers, not pulled from a textbook.
A
6Accelerated approval
Accelerated approval is a regulatory pathway that allows earlier market access for therapies that address serious conditions and fill an unmet medical need based on surrogate endpoints.
Addressable population
The addressable population is the subset of patients within a broader disease area who meet specific criteria for treatment with a given product or intervention.
Advisory board
An advisory board is a structured meeting where external experts provide insights to support strategic, clinical, or scientific decision-making in pharmaceutical development.
Artificial intelligence
Artificial intelligence (AI) refers to computer systems designed to perform tasks that typically require human intelligence, such as learning, reasoning, and decision-making.
Asset evaluation
An asset evaluation establishes the attractiveness, market potential and likelihood of success for an internal or external asset.
Attribution
Attribution refers to the process of linking a scientific, clinical, or strategic outcome to a specific source, action, or stakeholder, ensuring transparency and traceability.
B
4Benefit-risk assessment
Benefit-risk assessment is the structured evaluation of a treatment’s positive therapeutic effects against its potential risks, informing regulatory and clinical decisions.
Bibliometrics
Bibliometrics refers to the quantitative analysis of academic publications used to evaluate research performance and influence.
Biosimilar
A biosimilar is a biologic medicine that is highly similar to an already approved reference biologic, with no clinically meaningful differences in safety, purity, or efficacy.
Burden of proof
In market access and regulatory contexts, burden of proof refers to the obligation of pharmaceutical companies to demonstrate the value, efficacy, and safety of their products to key stakeholders.
C
11Channel strategy
Channel strategy refers to how pharmaceutical companies engage different communication and access pathways to reach key stakeholders across medical, payer, and patient channels.
Clinical benefit
Clinical benefit refers to the positive impact a treatment has on patient health, including symptom relief, disease modification, or survival improvement.
Clinical development
Clinical development is the systematic process of testing a new medical intervention in humans to establish its safety and efficacy.
Clinical differentiation
Clinical differentiation is the degree to which a product stands out from alternatives based on its therapeutic profile, safety, or ease of use.
Clinical landscape
The clinical landscape refers to the current state of clinical development activity within a specific disease area, including ongoing and completed trials, treatment approaches, and emerging standards of care.
Clinical meaningfulness
Clinical meaningfulness describes the real-world relevance of a treatment’s effects on outcomes that matter to patients, providers, and payers.
Collaboration network
A collaboration network is a visual or analytical representation of co-authorship and institutional relationships within scientific research communities.
Comparative effectiveness
Comparative effectiveness evaluates how a treatment performs relative to other available options in terms of efficacy, safety, and real-world outcomes.
Competitive landscape
The competitive landscape refers to the current set of products, companies, and strategies competing within a specific therapeutic area, market, or indication.
Conference landscape
The conference landscape refers to the network of scientific and medical meetings where new clinical data, research, and strategic priorities are presented and discussed.
Conference planning
Conference planning is the strategic coordination of a pharmaceutical company’s activities before, during, and after a scientific or medical meeting to maximize scientific impact and stakeholder engagement.
D
10Decentralised clinical trial (DCT)
A decentralized clinical trial (DCT) is a study that uses digital tools and remote methods to reduce or eliminate the need for in-person site visits.
Development pipeline
A development pipeline is the collection of drug or therapy projects that a company, disease area or industry has in discovery and development at a given time, from early research to possible market approval.
Digital activity
Digital activity refers to the online engagement of stakeholders across platforms such as social media, webinars, and digital conferences, providing insights into their interests, influence, and network.
Digital landscape
The digital landscape refers to the network of online platforms, behaviors, and content shaping scientific dialogue, stakeholder engagement, and perception within a therapeutic area.
Digital listening
Digital listening is the continuous monitoring and analysis of online conversations to capture insights on stakeholder perspectives, emerging topics, and perceptions of scientific data.
Digital Opinion Leader (DOL)
A DOL is an influential person or organization with a large online presence, often on social media, in the healthcare or pharmaceutical industry.
Digital transformation
Digital transformation is the integration of digital technologies into core pharmaceutical operations to enhance scientific, clinical, and commercial performance.
Disease burden
Disease burden refers to the total impact of a health condition on individuals, healthcare systems, and society, including clinical, economic, and quality-of-life dimensions.
Disease severity
Disease severity refers to the extent or intensity of a condition’s impact on a patient’s health, functioning, and quality of life.
Dose optimisation
Dose optimization is the process of identifying the most effective and safe drug dose for a specific patient population.
E
7Early access program (EAP)
An early access program (EAP) allows patients with serious or life-threatening conditions to access investigational therapies prior to full regulatory approval.
Eligibility criteria
Eligibility criteria are the inclusion and exclusion rules that define which participants can enroll in a clinical trial.
Engagement planning
Engagement planning is the strategic design of how and when to interact with external stakeholders to support scientific, clinical, and commercial goals.
Epidemiology
Epidemiology is the study of the distribution, patterns and determinants of health across defined populations.
Evidence generation programme
An evidence-generation program is a coordinated plan for producing clinical, real-world, and economic data to support the value and positioning of a pharmaceutical product.
Evidence hierarchy
An evidence hierarchy is a ranked framework that classifies types of evidence based on their methodological rigor and reliability.
External control arm
An external control arm uses data from outside a clinical trial to serve as a comparator for evaluating a treatment’s effectiveness.
F
3Feasibility planning
Feasibility planning is the process of evaluating whether a clinical trial or development strategy can be successfully executed based on operational, scientific, and market factors.
First-author
First-author refers to the individual credited with leading the design, execution, and authorship of a scientific publication.
Formulary inclusion
Formulary inclusion is the decision by a healthcare payer or institution to list a pharmaceutical product as an approved treatment option.
G
3Gap analysis
Gap analysis is the process of identifying missing evidence, insights, or capabilities needed to meet strategic, regulatory, or stakeholder expectations.
Generic medicine
A generic is a medication that is chemically identical to an approved brand-name drug and intended to offer the same clinical benefit at a lower cost.
Global value dossier (GVD)
A global value dossier (GVD) is the central evidence document a manufacturer builds so local teams can make a consistent case for a product's value to payers and HTA bodies.
H
5Health economic model
A health economic model is a structured tool used to estimate the costs and outcomes associated with a healthcare intervention over time.
Health Economics and Outcomes Research (HEOR)
HEOR is the discipline focused on evaluating the economic value, clinical outcomes, and humanistic impact of healthcare interventions to inform decision-making.
Health technology assessment (HTA)
A health technology assessment (HTA) is a systematic evaluation of the clinical, social, economic and ethical implications of a new medical intervention or technology.
HEOR stakeholder
An HEOR stakeholder is an individual or organization that uses health economics and outcomes research to guide decisions in healthcare policy, reimbursement, or treatment adoption.
HTA submission
An HTA submission is a formal package of clinical and economic evidence provided to a health technology assessment body to support product reimbursement or funding.
I
10Impact factor
An impact factor is a bibliometric score VISFO uses to rank the influence of an expert — whether a key opinion leader, digital opinion leader, key clinical investigator, payer-influencing expert, rising star or co-author — using publication volume, journal quality, authorship position and citation reach.
Implementation science
Implementation science is the study of how to promote the adoption and integration of evidence-based practices into real-world healthcare settings.
Incidence
Disease incidence is the occurrence of new cases in a defined population over a specified period. It can be measured as cumulative incidence or as a rate based on person-time at risk.
Inclusion/exclusion criteria
Inclusion and exclusion criteria define who can or cannot participate in a clinical trial, based on factors like disease state, age, comorbidities, or prior treatment.
Indication
An indication is the specific disease, condition, symptom or patient setting for which a treatment or intervention is approved or authorised.
Indication assessment
An indication assessment is the strategic evaluation of market opportunities within multiple potential indications to determine which to prioritize for development and launch, and maximize the commercial success of a new product or medical device.
Institutional affiliation
Institutional affiliation refers to the academic, research, or clinical organization with which a healthcare professional is formally associated.
Integrated evidence plan (IEP)
An integrated evidence plan (IEP) outlines the coordinated generation of clinical, economic, and real-world data to support a product’s lifecycle strategy.
Internal buy-in
Internal buy-in refers to gaining cross-functional agreement and support for a strategic decision, investment, or action plan within a pharmaceutical organization.
Investigator-initiated study (IIS)
An investigator-initiated study (IIS) is a clinical or scientific study developed and led by an independent researcher, often supported by pharmaceutical funding or materials.
K
3Key Clinical Investigator (KCI)
A Key Clinical Investigator (KCI) is a highly experienced healthcare professional with a proven track record in conducting successful clinical trials.
Key Opinion Leader (KOL)
A Key Opinion Leader (KOL) is a highly influential and respected expert in their field who shapes opinions and decisioning.
Key Opinion Leader (KOL) mapping
Key Opinion Leader (KOL) mapping is the process of identifying and analyzing key opinion leaders based on their influence, expertise, and relevance to a specific therapeutic area or strategy.
L
4Launch sequence optimisation
Launch sequence optimization is a strategic process that determines the best order and timing for launching a new drug across different markets.
Lifecycle evidence generation
Lifecycle evidence generation is the strategic planning and execution of data generation activities throughout a product’s development, launch, and post-market phases.
Line of therapy
Line of therapy refers to the sequence in which treatments are given to a patient, typically categorized as first-line, second-line, or third-line based on clinical guidelines or treatment history.
Literature library
A literature library is a curated collection of publications relevant to a specific individual, topic, or strategy, used to support insight generation and engagement planning.
M
14Market Access
Market Access is a function within pharmaceutical and biotechnology companies ensuring that the patients most likely to benefit from a new drug can access it, and that the drug is both cost-effective for healthcare systems and commercially viable for the manufacturer.
Market Access Key Opinion Leader (MAKOL)
A Market Access Key Opinion Leader (MAKOL) is a recognized expert who regularly publishes on market access themes, for example, disease burden, treatment cost-effectiveness and reimbursement challenges, within a specific therapeutic area.
Market conditioning
Market conditioning is the strategic process of shaping stakeholder awareness, perceptions, and expectations ahead of product launch or clinical milestone.
Market potential
Market potential is the estimated maximum revenue opportunity for a pharmaceutical product within a defined population, therapeutic area, or geography.
Market shaping
Market shaping is the deliberate effort to redefine or expand a therapeutic space by influencing standards of care, stakeholder behavior, or access pathways.
Market value
Market value refers to the current or projected financial worth of a pharmaceutical product or therapeutic area based on real-world sales, pricing, and market dynamics.
Medical Affairs
Medical Affairs is a strategic function within the pharmaceutical, biotechnology and consumer healthcare industries that communicates scientific data to healthcare professionals, payers and policymakers.
Medical insight capture
Medical insight capture is the process of collecting, analyzing, and synthesizing insights from healthcare professionals to inform strategy and decision-making.
Medical Science Liaison (MSL)
A Medical Science Liaison (MSL) is a scientific expert who engages with healthcare professionals to communicate clinical data and gather insights that inform medical and commercial strategy.
Medical strategy
Medical strategy is the plan that guides how scientific and clinical knowledge is generated, interpreted, and communicated throughout a product’s lifecycle.
Morbidity rate
Morbidity rate is a measure of how frequently a disease or health condition occurs within a specific population over a defined period of time.
Mortality rate
Mortality rate is a measure of the frequency of death in a defined population over a specified period, often used to assess the severity or impact of a disease.
Multi-stakeholder engagement
Multi-stakeholder engagement refers to the coordinated interaction with diverse healthcare decision-makers, including providers, payers, regulators, and patient advocates.
Multiplicity
Multiplicity refers to the increased risk of false-positive results when multiple statistical tests are performed in a clinical trial.
O
2P
16Patient advocacy group
A patient advocacy group is an organization that represents the interests of individuals affected by a particular disease or condition, often influencing research, policy, and access.
Patient engagement
Patient engagement is the active involvement of patients in the design, development, and evaluation of healthcare strategies, including clinical trials and evidence generation.
Patient-reported outcomes (PROs)
Patient-reported outcomes (PROs) are direct reports from patients about their symptoms, functioning, or quality of life, without interpretation by clinicians.
Payer Influencing Key Opinion Leader (PIKOL)
A Payer Influencing Key Opinion Leader (PIKOL) is a key influencer of healthcare policy and reimbursement decisions.
Peer-to-peer engagement
Peer-to-peer engagement involves direct scientific exchange between healthcare professionals, often facilitated by field medical teams such as medical science liaisons (MSLs).
Pharmacovigilance
Pharmacovigilance is the science and practice of monitoring, detecting, assessing, and preventing adverse effects or other drug-related problems after a product has entered the market.
Placebo-controlled study
A placebo-controlled study is a clinical trial in which the effects of an investigational treatment are compared against an inactive substance that mimics the treatment but has no therapeutic effect.
Population health impact
Population health impact refers to the measurable effect of a therapy or intervention on the overall health outcomes of a defined population.
Predictive analytics
Predictive analytics uses historical and real-time data to forecast future outcomes, helping guide strategic decisions in clinical development and market access.
Prevalence
Prevalence is the proportion of a defined population that has a disease at a specified point in time. It supports disease-burden analysis, population forecasting and access planning.
Price benchmarking
Price benchmarking is the process of comparing the price of a pharmaceutical product to similar therapies across markets to inform pricing strategy and negotiation.
Price potential
Price potential refers to the estimated price a pharmaceutical product could reasonably achieve based on its clinical value, competitive positioning, and payer willingness to pay.
Pricing and reimbursement
Pricing and reimbursement refers to the processes by which a pharmaceutical product is assigned a price and granted coverage or funding by healthcare payers.
Product value communication
Product value communication is the strategic process of articulating the unique attributes, patient benefits, and economic value of a drug or therapy.
Publication strategy
A publication strategy is a structured plan for disseminating scientific and clinical data through peer-reviewed journals and congresses to support a product’s development and value story.
Publication type
Publication type categorizes scientific articles by format and purpose, influencing how they are perceived and weighted in bibliometric analysis.
Q
2Qualitative research
Qualitative research is a method used to gather non-numerical insights into stakeholder behaviors, perceptions, motivations, and decision-making processes.
Quantitative research
Quantitative research involves the collection and statistical analysis of numerical data to identify patterns, test hypotheses, or measure outcomes.
R
10Real-world data (RWD)
Real-world data (RWD) refers to health-related data collected outside of traditional clinical trials, used to understand how treatments perform in routine clinical practice.
Real-world effectiveness
Real-world effectiveness measures how well a treatment performs in routine clinical practice, outside the controlled environment of clinical trials.
Real-world evidence (RWE)
Real-world evidence (RWE) refers to clinical insights derived from the analysis of real-world data (RWD), used to evaluate how treatments perform outside of controlled trial settings.
Regulatory strategy
Regulatory strategy is the plan that guides how a pharmaceutical company will navigate requirements for product approval, labeling, and post-marketing commitments.
Regulatory submission
A regulatory submission is a comprehensive dossier submitted to health authorities to seek approval for a new drug, indication, or formulation.
Reimbursement landscape
The reimbursement landscape refers to the policies, payer expectations, and pricing mechanisms that influence whether and how a product will be funded.
Research and development (R&D)
Research and development (R&D) is the process of discovering, designing, and testing new pharmaceutical products to advance medical science and improve patient outcomes.
Rising Star
A Rising Star is a medical or scientific professional in the early to mid-stage of their career who demonstrates potential to become a prominent and influential voice in their field.
Risk factor
A risk factor is any attribute, condition, or behavior that increases the likelihood of developing a disease or experiencing an adverse health outcome.
Risk-sharing agreement
A risk-sharing agreement is a contractual arrangement in which a pharmaceutical company and payer share financial or clinical risk based on treatment outcomes.
S
8Scientific exchange
Scientific exchange refers to non-promotional, data-driven communication between a pharmaceutical company and healthcare professionals, focused on advancing clinical understanding.
Scientific landscaping
Scientific landscaping is the systematic analysis of published and emerging research to identify trends, gaps, and strategic opportunities within a therapeutic area.
Sentiment analysis
Sentiment analysis is the use of natural language processing (NLP) and machine learning to evaluate the tone and emotional context of written or spoken content.
Share of voice
Share of voice (SOV) is a metric that measures the proportion of total mentions or visibility a product, brand, or company receives within a defined competitive or thematic space.
Stakeholder mapping
Stakeholder mapping is the creation of a comprehensive overview of key stakeholders relevant to a particular therapeutic area, indication, condition or product.
Stakeholder segmentation
Stakeholder segmentation is the process of categorizing healthcare stakeholders into groups based on shared attributes, interests, or behaviors to tailor engagement strategies.
Stakeholder sentiment
Stakeholder sentiment refers to the tone and attitude expressed by healthcare professionals, payers, patients, or other influencers toward a product, topic, or company.
Surrogate endpoint
A surrogate endpoint is a biomarker or intermediate measure used in clinical trials as a substitute for a direct measure of clinical benefit.
T
5Target product profile (TPP)
A target product profile (TPP) outlines the ideal characteristics of a pharmaceutical product to guide development and align stakeholder expectations.
Thought leader
A thought leader is an individual widely recognized for their expertise, original ideas, and ability to influence thinking and practice within a specific field.
Time-to-peak-uptake
Time-to-peak-uptake is the period it takes after launch for a product to reach its maximum level of market adoption.
Treatment landscape
The treatment landscape describes the full range of available therapies and treatment strategies for a particular disease or condition.
Trial site analysis
Trial site analysis is the evaluation of potential clinical trial sites to optimize study performance.
U
2Unbranded engagement
Unbranded engagement involves scientific or educational communication that does not promote a specific product but builds awareness around a disease, unmet need, or treatment approach.
Unmet need
Unmet need refers to a gap in medical care where current treatment options are inadequate, unavailable, or ineffective for a specific patient population or condition.
V
2Value proposition
A value proposition is a clear, evidence-based summary of the benefits a product offers to patients, providers, and payers.
Voice of the customer
Voice of the customer (VoC) refers to insights gathered from stakeholders that reflect their needs, expectations, and experiences with a product or therapeutic area.
W
2Willingness to pay
Willingness to pay refers to the maximum amount a healthcare payer, provider, or system is prepared to spend for a treatment, based on its perceived value and health outcomes.
Workflow integration
Workflow integration refers to the alignment of a product or tool with the routines and systems used by healthcare professionals in clinical practice.
The glossary is living. If you spot a gap, an outdated definition or want a worked example, tell us and we'll add it.