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Lumanity

Lumanity is listed as a mid sized business research supplier in the Scientist.com network, with 1 site in 1 country and 1 service area.

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Type of company: Mid sized business

Brand Communications

Patient-HCP Communication Aids Design and development of tools (visuals, guides, devices) that facilitate clear, accurate, and empathetic two-way dialogue between patients and their healthcare providers.

Clinical Consulting

Regulatory Compliance & Documentation Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations.
Regulatory Consulting Ensure that each product or device complies with all FDA rules and regulations.

Clinical Trials

Regulatory Operations Ensure that all specific regulatory documents are published and properly organized before submission. 
Statistical Analysis Planning Technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary variables...
Study/Site Feasibility Study Explore and test study practicality.
Synthetic Control Arm Creation Using RWD Using patient data from sources like electronic health records or claims databases to construct a comparator group for clinical trials, instead of enrolling a separate group of control patients.

Commercial Consulting

Portfolio Management Manage a portfolio of projects in early-stage drug discovery and provide factors that determine the success of the proposed portfolio.

Creative

Infographic Create a quick visual representation of information, data or knowledge.
Product Marketing Bring a product to market.

Data Science/Bioinformatics

RWE/HEOR Market Analysis A process to understand how a drug is performing in the market and possible opportunities in the market

Drug Development

Consulting Services Work with consultants who provide expert advice in various areas of research and technology.

Show all 190 services 178 more

HEOR

Burden of Illness/Disease Strategy and study related to assessing the impact (economic, non-economic) of disease on health outcomes in a country, region, community, patient, or health system.
Clinical Outcomes Measures patient's symptoms, mental, or physical effects of a disease or condition on how the patient functions, recorded by practitioner, provider, or instrument (not by patient).
Comparative Effectiveness The generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care.
Cost Benefit Analysis Economic evaluation in which costs and benefits (outcomes) are expressed in monetary units, to determine if the benefits of an intervention outweigh the costs.
Cost Effectiveness Analysis Compare alternative treatments that lead to similar health outcomes.
Decision Analytic Modeling Assess effects, costs and economic outcomes of treatment. These include cost-effectiveness models and budget impact models.

Show all 13 in HEOR 7 more

Health Economics and Outcomes Research (HEOR) Evaluate data collected during drug development to maximize the value of a therapeutic product.
HEOR Adherence Studies Strategy or study that assess extent to which patients or subjects follow recommendations for prescribed intervention; may include compliance assessment, as well as reasons related to actual or potential non-adherence.
Patient Reported Outcomes (PRO) Assessment of health outcomes directly reported by the patient who experienced it, without interpretation of the patient's response by a clinician.
Patient Treatment Patterns Assessment of treatment processes and patterns within clinical practice.
Resource Utilization Descriptive and/or analytical review of a treatment that investigate the marketing, distribution, prescription, and use of drugs in populations. Endpoints to be assessed are the medical, social, and economic outcomes.
Systematic Literature Review Summarizes the results of research (that meet pre-defined eligibility criteria for inclusion) and provides a high level of evidence on the outcomes assessed.
Therapy Switch Insight into the reasoning of patients switching treatments and the outcomes of the switch.

In Vitro Pharmacology

Target Validation Demonstrate that modification of target activity has potential therapeutic benefits.

Market Access

Academy of Managed Care Pharmacy (AMCP) Dossier Summary document that presents clinical, economic, and humanistic value of an intervention and associated disease state with the supporting evidence, formulated from the perspective of a particular stakeholder...
Communication & Advertisement Distribution of a range of materials, through various communication channels, to highlight a message containing scientific-related topics
Emerging Market Opportunities Analyze risks and opportunities in new markets and ensure patients have timely and continued access to new treatments.
Environmental Analysis Research or strategy related to understanding the market (size, competition, reimbursement, challenges, etc.) and is a tool used to understand if a product can be launched in the market.
Formulary & Reimbursement Strategy Develop strategy and narrative to gain formulary access on insurance plans.
Health Technology Assessment (HTA) Preparation/Strategy Dossier Development Perform evidence preparation and/or create strategies for the systematic evaluation of the properties, effects, and/or impacts of health care technology.

Show all 16 in Market Access 10 more

Health Technology Assessment Submission (HTA Submission) Analyze the medical, social, ethical, humanistic, and economic considerations of a drug, medical device, or clinical procedures. Submissions are sent to regulatory agencies with different requirements that govern...
Market Access - HTA Landscape Assessment Conduct a HTA landscape assessment to evaluate the direct and indirect impact of health technology on a specific region.
Market Access Materials Find general strategies and methods used to market a pharmaceutical product or device.
Market Research & Business Intelligence Run market feasibility studies, establish customer needs, improve product performance and analyze competition.
Marketing and Commercialization Identify, promote and prove the value of a particular drug to key stakeholders.
Payer Toolkit Communicate product value to payers utilizing digital and mobile technology (For example, Payer-Facing iPad Models).
Population Health Analytics Aggregation of patient data across multiple health information technology resources, the analysis of that data into a single, actionable patient record, and the actions through which care providers can improve both...
Pricing Strategy Develop value story tailored to a payer audience that will determine the appropriate price for treatment.
Study Start Up Consulting Request for RWE/HEOR/Market Access Study Start Up Consulting
Value Dossiers Development Summary document that presents clinical, economic, and humanistic value of an intervention and associated disease state with the supporting evidence, formulated from the perspective of a particular stakeholder...

Medical Communications

1:1 KEE Engagement Management Compliant, individualized planning and documentation of scientific exchange meetings between Medical Science Liaisons (MSLs) and Key External Experts (KEEs).
Abstracts Request services related to the writing and review of abstracts
Advisory Boards Logistical and content support for organizing panels of external experts to gather critical strategic insights and feedback on therapeutic and product development plans.
All Medical Meeting Materials and Content End-to-end service providing slide decks, handouts, training guides, and logistics required to run an internal or external medical meeting successfully.
Animated Content Development of diverse visual, interactive digital assets like infographics, data visualizations, and short animations to explain complex medical and scientific concepts simply.
Communication Plan Communications plan enables organizations and corporations to effectively deliver information to appropriate stakeholders and customers.

Show all 68 in Medical Communications 62 more

Competitive Intelligence Develop a coordinated competitive intelligence program which contains a systematic collection and analysis of information from multiple sources about a specific business's industry.
Congress Assets Development of all visual, printed, and digital materials needed for a medical congress, including posters, booth graphics, and digital screens.
Congress Listening/Insights Report Systematic collection, analysis, and summary of key discussions, scientific trends, competitor movements, and data presented at major medical congresses.
Congress Planning Comprehensive logistical and content management for a company's participation in major medical conferences, including booth design, abstract submission, and staff briefing.
Consensus reports Develop and submit a report that is a comprehensive examination by an expert panel of a scientific or medical issue.
Creation of Non promotional Education/Awareness Content Development of scientifically rigorous, balanced materials (like disease state primers or journal clubs) aimed purely at enhancing clinical understanding, not driving product use.
Creation/Maintenance of Scientific Narrative and Lexicon Establishing and managing a unified set of core messages and terminology used across all company communications to ensure consistent scientific understanding.
Data Visualization Visualize data collected from clinical trials and/or clinical research.
Development of non promotional Medical Education Plan Creation of a strategic, compliant framework outlining educational needs, target audiences, content objectives, and tactical deployment of medical materials without promoting a product.
Digital Opinion Leader (DOL) Mapping and Engagement Planning Systematic process to identify and compliantly plan engagement with influential digital experts (e.g., social media, online forums) within the medical and scientific community.
Direct to Patients (D2P) A healthcare model where pharmaceutical companies or other healthcare providers engage directly with patients.
Disease or Drug-Related Literature Curation, development, and compliant distribution of written materials (e.g., abstracts, manuscripts, summaries) related to a specific illness or medicinal product.
Distribution Strategy & Channel Recommendations Developing plans for how and where medical content (e.g., publications, training, MOA videos) will be efficiently delivered to the target healthcare audience.
Educational Content Development Comprehensive development of diverse, multi-channel content assets that offer education and information about a specific therapeutic area or medicinal product.
Educational Impact Analysis Measurement and evaluation of non-promotional activities to determine the change in healthcare professionals' knowledge, attitude, or behavior resulting from the education.
eLearning Modules Development Development of interactive, self-paced digital courses that allow learners (internal staff or external HCPs) to master scientific content or therapeutic knowledge remotely.
Expertise in Adult Learning Principles Applying instructional design methods (like andragogy) to training and educational materials to maximize retention, application, and skill development for mature learners.
Fact/Reference Checks Rigorous verification of all scientific claims, data points, and quotations against original source materials to ensure medical and regulatory accuracy.
Faculty and/or Steering Committee Management Oversight and compliant coordination of expert groups involved in clinical trials, publication steering, or educational program development.
Gap Analysis Compare the actual performance of an organization or corporation with potential or desired performance, as ways to effectively analyze resource management or allocation.
HEOR/Value Publications Writing and submission of manuscripts and abstracts focusing on Health Economics and Outcomes Research (HEOR) data, which demonstrate the economic and value proposition of a therapy.
Internal Evidence Providing organized access and summaries of unpublished company-held data (e.g., clinical study reports) to internal medical and scientific teams.
KEE Identification, Mapping & Engagement Planning Systematic process to identify, categorize, and strategically plan outreach to Key External Experts (KEEs) based on their influence, specialization, and research activity.
KOL Engagement & Management Building and maintaining compliant, value-driven relationships with Key Opinion Leaders (KOLs) to collaborate on scientific exchange and clinical education initiatives.
Landscape Analysis Find a cohesive and consistent view of your main organization. Develop initiatives in analyzed areas of operations and analyze chosen key aspects of them.
Literature Audits A systematic review and assessment of all published and unpublished scientific literature related to a product or therapeutic area for compliance or strategic purposes.
Market & Competitor Analyses Evaluating the current therapeutic landscape, identifying unmet needs, and assessing the scientific positioning and data of competitor products.
Mechanism of Disease (MOD) & Mechanism of Action (MOA) Videos Production of dynamic, scientifically accurate animated videos illustrating how a disease develops (MOD) and how a drug therapeutically affects the body (MOA).
Medical Academy Training Developing structured, curriculum-based training programs for internal medical affairs teams, focusing on scientific, therapeutic, and compliance knowledge mastery.
Medical Affairs Services for non-promotional scientific exchange, supporting the dissemination of accurate medical data and the development of educational content.
Medical Affairs Dossiers Develop medical affairs dossiers such as Global Value Dossiers or AMCP Dossiers.
Medical Communications Master Class Design and execution of in-depth, high-level educational sessions led by top Key Opinion Leaders (KOLs) focusing on advanced clinical or scientific topics.
Medical Education & Training Creation, development, production and dissemination (internally and externally) of non-promotional disease and treatment-related materials that educate specifically with medicine or healthcare.
Medical Infographics Creation of visually engaging, concise graphic summaries to rapidly convey complex clinical data, scientific concepts, or statistical results.
Medical Literature Reviews Systematic searching, appraisal, and synthesis of published scientific literature to generate evidence-based reports on a specific topic, disease, or treatment.
Medical Publications Make clear and accurate presentations of scientific and technical data.
Medical Science Liaison (MSL) External Presentation Develop and design Medical Science Liaison External Presentations.
Medical Science Liaison (MSL) Support Support services for Medical Science Liaisons (MSL).
Medical Science Liasion (MSL) Training Training for medical science liaisons who want to work in pharmaceutical, biotechnology, medical device, and managed care companies.
Medical Website/Hub Design Design and maintenance of a compliant online portal serving as a repository for scientific publications, educational resources, and medical information for external stakeholders.
Medical Writing and Editing/Manuscript Development Communicate scientific, technical and health-related information to a range of audiences.
Meeting and Events A gathering of people with a shared purpose, often for business or organizational goals
New Product/Indication Launch Planning Strategic development of the medical affairs communication road map and activities necessary to support the successful introduction of a new therapy or approved use.
Patient Advocacy Group Engagement Compliant collaboration and information sharing with non-profit organizations that represent patient communities to understand their needs and provide education.
Patient Narratives Compliant collection and use of individual patient stories to illustrate the impact of a disease or treatment, often for training or empathy-building purposes.
Payer Directed Communication Tools (other than Dossiers) Request services related to payer directed communication tools.
Postcast Production Production of audio content featuring expert interviews, clinical data reviews, or scientific discussions, providing easily digestible learning for healthcare professionals (HCPs).
Proactive and Reactive Medical Affairs Assets Development of both planned educational materials and responsive documents used by Medical Affairs to address scientific information gaps.
Publication Writing Create further publication documents. Investigational device exemptions (IDEs) BLAs, MAA, PMA, eCTDs, informed consents, CMC and manufacturing reports, orphan drug designations (ODD), briefing books.
Publications Plan Development & Management Strategic planning and oversight of all research dissemination activities, including outlining target journals, timelines, authors, and compliance for clinical data publications.
Regulatory Submissions and Compliance Draft, format, and submit documents to Pharmaceutical approval agencies according to documentation and guidelines. This includes documents such as NDAs, INDs, SUSARs, AE reporting, RMPs, and PSURS.
Review Article/ Submission Drafting and managing the process of submitting an objective, comprehensive summary of the current literature on a disease or treatment area to a peer-reviewed journal.
Sales Training Modules Develop and distribute sales training modules.
Sales Training Webinar Slide Decks Develop slide decks for sales training webinars.
Scientific Platform Develop a rigorous approach to creating a core story (grounded in the scientific literature) for a product. This involves identifying core concepts that address disease states, clinical needs, and product-related...
Scientific Positioning Strategic development of the evidence-based argument that defines how a drug or therapy is distinct, superior, or beneficial relative to competitors in the market.
Scientific Share of Voice Measurement Quantitative analysis tracking the volume and nature of a company's, or a competitor's, scientific discussion across publications and medical meetings.
Scientific Training Solutions Developing comprehensive educational programs and materials to ensure internal teams, field medical staff, or external partners are fluent in the therapeutic area and product data.
Strategic Medical Communication Development & Planning High-level planning to define the core scientific messages and the tactical strategy needed to effectively convey clinical data to key stakeholders over time.
Survey to KEE’s, External Expert Mapping Conducting compliant research and analysis to identify, categorize, and gather feedback from influential external medical and scientific experts.
Target Product Profile (TPP) A sponsor prepared document which summarizes the drug development program that is described in terms of the labelling concepts. This profile is a communication method used between the FDA and sponsor which can be used...
Therapy Area Disease Insights Report Creation of a comprehensive analysis of the current scientific, clinical, and competitive landscape within a specific therapeutic area.

Medical/Commercial

Health & Pharmacoeconomics Identify, measure and compare the cost-benefit ratio of products and services.

Old Category HEOR, RWE, Market Access

Data - Other Extract insights and patterns from large and complex datasets.
Non-Interventional Studies Examine different aspects of drug usage, including efficacy and safety, under real-life conditions.
Patient-Reported Outcome Studies Get self-reported information regarding the personal health status of an individual.
RWE/HEOR/Market Access Disease/Clinical Outcomes Study the course of disease and the possible outcome of disease, including expected frequency.
RWE/HEOR/Market Access Hybrid Study Combine different methodologies (retrospective, prospective, registries, chart or claims review, electronic medical/health records) to gain insights into real world patient behavior or drug use.
RWE/RWD Enriched Studies Combine different methodologies (retrospective, prospective, registries, chart or claims review, electronic medical/health records) to gain insights into real world patient behavior or drug use.

Primary Market Research

Advertising Testing (qual/quant) Assesses reactions to creative advertising materials using both qualitative and quantitative methods. Supports refinement of campaign assets before launch.
Asset Prioritization Studies Assesses stakeholder interest and unmet need across multiple assets in development. Helps pipeline teams allocate investment and identify lead candidates.
Behavioral Segmentation Groups stakeholders based on their actions and choices rather than demographics. Enables precise targeting and tailored intervention strategies.
Competitive Intelligence and Message Recall Measures awareness of competitor messaging and materials among stakeholders. Informs counter-positioning and promotional strategy.
Competitive Landscape Research Maps competitor products, positioning, trial activity, and perception among stakeholders. Delivers inputs for SWOT analysis and differentiation strategy.
Detail Aid and Promotional Materials Testing Tests visual aids and promotional content with HCPs for clarity, accuracy, and persuasiveness. Delivers insights for regulatory compliance and effectiveness.

Show all 34 in Primary Market Research 28 more

Early Concept Testing Evaluates initial ideas or positioning strategies with target audiences before refinement. Provides go/no-go input and direction for further development.
Ethnographic research (in-home, diary studies) Observational or self-reported research capturing real-world experiences in home or daily life contexts. Provides authentic behavioral data used for patient journey mapping and product usability evaluation.
Focus groups (in-person/virtual) Facilitated group discussions to evaluate reactions to concepts, messages, or services. Produces consensus insights and contrasting views used to refine strategy, materials, or offerings.
Generalists and specialists (e.g., oncologists, neurologists) Research targeting both broad-practice physicians and specialists to understand treatment preferences, diagnostic challenges, and clinical decision-making. Provides comparative insights for segmentation, messaging...
Growth Potential Quantifies market size, penetration rates, and uptake forecasts for new products or categories. Guides business development and portfolio prioritization.
In-depth interviews (IDIs) One-on-one qualitative interviews conducted with key stakeholders to explore beliefs, decision drivers, and unmet needs. Delivers rich narrative data to inform trial design, product positioning, and message development.
Interpretation and Real-Time Translation for Live Interviews Live translation during interviews or advisory boards to enable multilingual engagement. Supports seamless international research execution.
Iterative concept/message testing with interim adjustments Tests concepts or materials in cycles with refinements after each round based on feedback. Delivers optimized content that evolves with stakeholder input.
Journey Mapping (Patient, HCP, Payer) Visual representation of stakeholder experiences across disease or treatment timelines. Identifies pain points, decision triggers, and opportunities for engagement or support.
Launch Readiness Assessments Evaluates internal and external preparedness for product launch, including sales force, market awareness, and access environment. Identifies gaps and supports launch planning.
Lifecycle Extension Concept Testing Tests ideas for extending the commercial life of a product (e.g., new formulations, indications). Supports long-term planning and investment decisions.
Market Opportunity Assessments Quantifies addressable market size, unmet needs, and competitive landscape. Supports go/no-go decisions and commercial forecasting.
Message / Claims testing Iterative research to assess clarity, relevance, and impact of key messages. Delivers validated communications that align with stakeholder expectations.
Message recall and aided/unaided awareness studies Studies that assess brand or campaign awareness with and without prompts. Data is used to measure campaign reach, retention, and comparative brand effectiveness.
Name Testing - Market Research Tests product or brand names for memorability, appropriateness, and appeal across markets. Supports final naming decisions and regulatory readiness.
Payer and HTA Expectations Research Engages payers and HTA bodies to uncover evidence needs, pricing thresholds, and access drivers. Informs clinical and economic evidence generation planning.
Persona Development Synthesizes qualitative and quantitative data to build detailed, actionable profiles of stakeholder archetypes. Supports targeted communications and segmentation strategies.
Positioning and Value Proposition Testing Tests various positioning statements and value messages with target audiences. Refines messaging to maximize resonance and differentiation.
Primary Market Research Primary market research, such as, focus groups, surveys, interviews and data collection field services.
Product Landscape and Unmet Needs Reports Synthesizes secondary data and expert input into landscape maps and gap analyses. Informs asset development and positioning.
Psychological Research Explores cognitive and emotional drivers of stakeholder behavior. Informs persuasive communication and behavior change strategies.
Segmentation and Profiling Divides target audiences into distinct groups based on attitudes, behaviours, or demographics. Informs tailored messaging and targeting strategies.
Sequential qual-quant studies Combines initial qualitative exploration with follow-up quantitative validation. Ensures both depth and scale in evaluating concepts, needs, or strategies.
Simulation Models (e.g., uptake models) Builds dynamic frameworks to simulate adoption, market share, or treatment behavior over time. Supports forecasting and strategic scenario planning.
Strategic Recommendations for Brand Teams Delivers synthesized insights and data-driven strategic guidance to commercial teams. Supports brand planning and lifecycle management.
Target Product Profile (TPP) Testing Tests stakeholder reactions to hypothetical product profiles across key attributes. Guides clinical development prioritization and access positioning.
Tracking - Market Research Longitudinal studies that monitor key metrics like awareness, usage, and satisfaction over time. Supports campaign optimization and lifecycle planning.
Virtual Reality Simulations (e.g., Mock Detail Aids) Immersive simulations that test materials or concepts in realistic digital settings. Provides experiential feedback on content usability and engagement.

Real World Evidence & Data

Claims Data - Medical Includes hospitalization,physician visits,emergency department visits. May or may not include laboratory information including resource utilization, costs or charges, as well as ICD-9 or 10 codes.
Claims Data - Pharmacy Includes medications, prescription orders, payment submissions, patient adherence, among others.
Cohort Study Investigating the causes of disease to establish links between risk factors and health outcomes.
Data Asset Validation Tools for validating that patient data and source has been accurately recorded.
Data Merging Tools for combining various data sets into a single data set. Includes data consolidation.
Exploratory Study Explore study design, outcomes, data-collection method, and selection of population for a topic that needs more research information.

Show all 29 in Real World Evidence & Data 23 more

HealthVerity - Health Data Platform HealthVerity platform serves as the foundation for the rapid creation, exchange and management of healthcare and consumer data. Through best-in-class identity resolution and matching capabilities, increased...
Meta-Analysis Use quantitative statistical approaches to pool results across multiple studies to improve power or resolve uncertainty; may be used in conjunction with a systematic review.
Multi-Source Data Pools Multiple data sources aggregated into singular platforms for analysis. May or may not include real-time analytics capabilities.
Non-Comparative Study Assess an intervention using a single arm study design (without a control or comparator group).
Patient Reported Outcomes (PRO) Databases Database or collection of data related to health outcomes directly reported by the patient who experienced it, without interpretation of the patient's response by a clinician or anyone else.
Predictive Analytics Variety of statistical techniques from data mining, predictive modeling, and machine learning, that analyze current and historical facts to make predictions about future or otherwise unknown events.
Pregnancy Registries Database containing, through utilizing observational research methods, standardized data about women taking medication or vaccines while pregnant. Data may also collected on the newborn.
Quantitative or Qualitative Research Either to understand concepts, thoughts, or experiences with qualitative research or to quantify the problem by generating numerical data or data that can be transformed into usable statistics with quantitative research.
Real World Evidence (RWE) Studies Studies (prospective or retrospective) utilizing data obtained from "real world settings" , and is outside the tight controls of a clinical trial design.
Real-World Data Acquire real-world data from patients' electronic medical records including clinical information generated during the course of healthcare.
Real-World Evidence Acquire clinical data from patients' medical records to analyze trends and the frequency of occurrence of different medical conditions.
Registries - Disease Database containing, through utilizing observational research methods, standardized data about patients who have the same disease.
Registries - Patient Database containing, through utilizing observational research methods, standardized data about patients who have the same condition, disease, or exposure and is used to evaluate an outcome
Registries - Product Includes specific information about a product of interest, route of administration, dose, duration of use, start and stop date.
Retrospective Exploratory Studies Retrospective exploratory studies
RWD - COVID-19 Data from COVID-19 patients, can include diagnosis, treatment, among others.
RWD - Diagnostics/Laboratory Includes information on laboratory procedures/results.
RWD - Electronic Medical Record (EMR) Digital version of a patient's medical or health chart containing demographic, clinical, medical, and other treatment information.
RWD - Genomics Genomic data collected from a patients with different diseases, can be derived from a range of sources.
RWD - Oncology Data from oncology patients, can include clinical treatment, diagnosis, among others.
RWD - Rare Diseases Data from patients with rare diseases, can include clinical treatment, diagnosis, among others.
RWE/RWD Observational Research Research method for documenting clinical, economic, and or humanistic outcomes of actual medical practice absent the constraints of a more formal experimental design. See also Pragmatic Clinical Trials.
Secondary Real World Evidence Analyze clinical trial data.

Regulatory Affairs

Life Cycle Management Plan and strategy of the data collection and information throughout the different phases of product development (portfolio assessment, pre-clinical trials, clinical trials, pre-authorization, post-authorization, and RWE)
Periodic Safety Update Report (PSUR) Preparation of safety reports to report adverse events that occurred during a specified time period. Evaluate if safety profile of treatment has changed since last report
Post Authorization Efficacy Study (PAES) Answer uncertainties in efficacy of treatment, and improve understanding of treatment and the benefit-risk profile. These studies are specifically asked for by European Medicines Agency (EMA) to continually grant...
Post Authorization Safety Study (PASS) Evaluate the safety, benefit-risk profile, and risk management of a treatment. These studies are specifically asked for by European Medicines Agency (EMA) and they can be mandatory or voluntary.
Post-authorization Safety Studies Research efforts conducted after a drug has been approved for market to monitor its safety profile in the general population. These studies aim to identify, characterize, or quantify potential adverse effects...
Regulatory Submission Documents Request services related to the submission and writing of New Drug Applications (NDA), Investigational New Drugs (INDs), and Investigator Brochures (IB) to the FDA and other regulatory bodies.

Show all 8 in Regulatory Affairs 2 more

Risk Benefit Assessment Determine ratio of treatment risk to the potential benefits.
Safety Signals Early indication that a new or unknown adverse event occurred that may be caused by treatment and investigation is needed to determine a causal relationship. Can be investigated through spontaneous reports, studies...

Other services

NDA Writing Receive assistance in the NDA application process.
Plain Language Summaries Request services related to the creation of plain language summaries.

Service areas:

Drug development

United Kingdom London 1 site

BresMed provides health economic solutions to the global pharmaceutical industry. Founded in 2006 and based in Sheffield, UK, BresMed has worked closely with the industry to develop economic modelling for submission to Nice, the SMC and PBAC, as well as other European and international fourth-hurdle authorities. Our most recent submissions include Yervoy® (BMS) for the treatment of advanced melanoma (NICE; STA), Botox® (Allergan) for the treatment of Chronic Migraine (NICE; STA), Buccolam® (ViroPharma) for the treatment of acute epilepsy (SMC) and Colomycin® (Forest Laboratories)...

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Our most recent submissions include Yervoy® (BMS) for the treatment of advanced melanoma (NICE; STA), Botox® (Allergan) for the treatment of Chronic Migraine (NICE; STA), Buccolam® (ViroPharma) for the treatment of acute epilepsy (SMC) and Colomycin® (Forest Laboratories) for the treatment of lung infection in cystic fibrosis (NICE; MTA).

As a team of approximately 20 economic modellers, statisticians and clinical writers, we are passionate about our work and deliver targeted and robust research. We have significant experience dealing with health technology assessment groups at all levels: project managing submissions, producing economic models, conducting utility studies, analysing trial data and the submission of patient access schemes. Working closely with our clients, we provide insight and advice on every aspect of the process. In addition, BresMed offer related services, including budget impact modelling, strategic pricing support, input to clinical trial design, and training in the health economic arena.

Website: www.lumanity.com

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