Payer material development for vaccines in hepatitis A
e-v@luate platform on vaccines for hepatitis A
Burden of disease literature review on hepatitis A in the UK and Ireland
Hepatitis B
Systematic literature review of a treatment for chronic hepatitis B
Preparation of a NICE submission for a hepatitis B drug
SMC submission for a treatment for chronic hepatitis B
Database analysis to calculate the economic burden of hepatitis B in the UK
Hepatitis C
Therapeutic area strategy analysis and reporting in chronic hepatitis C virus
Biomarkers in the treatment of hepatitis C virus infected patients – personalised medicine
Maximizing the use of a treatment for hepatitis C-infected patients through personalised medicine – extending the tool to additional treatments
Treatment algorithm for hepatitis C treatment
One-pager value communication tool for Hepatitis C
Comprehensive literature research in chronic hepatitis C in Asian countries
Database development and analysis in hepatitis C
Concept elicitation and cognitive debriefing interviews with hepatitis C patients in multiple countries
Development of an EMA summary document for several instruments used in hepatitis C trials
Development of a PRO outcomes summary document and communications support in hepatitis C trials
Description, interpretation and analysis of pooled data related to the use of several questionnaires, scales and screening tests in three hepatitis C clinical trials
Conceptual model for patients with hepatitis C
Psychometric validation of a hepatitis C symptom checklist using phase III trial data
Treatment patterns, healthcare utilization and costs associated with the hepatitis C virus in Japan
Value dossier on a treatment for post liver transplant in paediatric patients
Development of an economic model for treatment in post-liver transplant in paediatric patients
Structured literature reviews on the burden of disease of nonalcoholic steatohepatitis (NASH)
Strategic review and recommendations for paediatric endpoints to assess pruritis in colostatic liver disease
Written critique of hepatology
Measures for use in patients with autosomal dominant polycystic kidney and liver disease: development and validation of a symptom measure and validation of a health survey
Development of the evidence base regarding treatment patterns, cost and burden of disease for patients with hereditary angioedema to support the use of a new treatment
Communications package in hereditary angioedema
Clinical endpoint review, recommendations and update of an FDA submission package in hereditary angioedema
Hereditary angioedema clinical trial endpoint review, recommendations and FDA PRO submission package
Pooled clinical trial validation analysis of a PRO primary endpoint in hereditary angioedema to include in FDA submission package
FDA meeting support for a hereditary angioedema submission
Evaluation of market research reports in hereditary angioedema to support PRO submission package
Analysis of Visual Analogue Scale (VAS) summary scores with Last Observation Carried Forward (LOCF) in hereditary angioedema
Psychometric validation analysis of VAS summary scores in hereditary angioedema
Patient interviews for the face and content validation of the Patient Global Impression in hereditary angioedema
Psychometric validation of the 6-item and 8-item composite severity scores in hereditary angioedema
Consulting on the linguistic validation of a hereditary angioedema questionnaire into French, German and Portuguese
Cognitive debriefing of a questionnaire in hereditary angioedema patients
Validation and modifications to a questionnaire in hereditary angioedema patients
Consultancy services for linguistic validation of a hereditary angioedema diary
Publication strategy to present the results of studies in hereditary angioedema
Patient interviews to support a PRO submission package in hereditary angioedema
PRO briefing document in hereditary angioedema
Strategic consulting and analysis in hereditary angioedema
Re-analysis of patient composite score in hereditary angioedema
Training materials for a PRO questionnaire in hereditary angioedema
Exploration of IQ as a relevant endpoint in Hunter’s syndrome
Endpoint review in Hunter’s syndrome
PRO dossier on the Disease Activity Score (DAS), Scales of Independent Behaviour-Revised (SIB-R), Behaviour Rating Inventory of Executive Function (BRIEF) and Vineland Adaptive Behaviour Scales (VABS) for Hunter’s syndrome
Strategic PRO and ObsRO analysis of a Hunter’s Syndrome clinical trial database
Regulatory support for questionnaires in Hunter’s syndrome
Strategic treatment pathways for treatment in pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH)
Update to payer value decks in PAH and CTEPH
Framework for real world evidence generation in PAH and CTEPH
Strategic plan and real-world evidence toolkit in PAH and CTEPH
Consultancy on interpretation of phase III trial endpoints in PAH and CTEPH
Meta-analysis, systematic literature review, data extraction and report on an oral combination treatment of PAH
Systematic literature review, data extraction & report on sensitivity analyses and a meta-analysis of an oral combination treatment of PAH
Meta-analysis of an oral combination treatment of PAH
Meta-analysis of an oral treatment of PAH – exploratory analyses on the effect of administering additional PAH-specific therapy upon two additional endpoints
Literature review of pulmonary hypertension secondary to chronic obstructive pulmonary disease (COPD)
Utility assessment in PAH
Literature review of PAH secondary to chronic obstructive pulmonary disease (COPD)
Interpretation of clinical trial results in PAH
Cognitive debriefing interviews with patients with PAH
Network meta-analysis of combination therapies in PAH
Psychometric validation of the Living with Pulmonary Hypertension (LPH) questionnaire in PAH
PRO claims for PAH – endpoint review and regulatory support for the FDA and EMEA
PRO claims for PAH: endpoint review, regulatory support and qualitative patient interviews
Qualitative research to explore patient preference for modes of administration in PAH treatments
Budget impact model for an anti-hypertensive treatment
UK cost offset model of two treatments for hypertension
Preparation of an interactive report on a cost-offset model for a treatment for hypertension
Asian value dossier for hypertension
Heart study economic model in hypertension
Advisory board on hypertension
Cost model for a direct renin inhibitor medication for the treatment of hypertension
Validation of an adherence questionnaire for hypertension patients utilizing administrative data
Hypertension database analysis in Japan
Data management and reporting on a cardiovascular health outcomes project switching study in hypertension
Development of a compliance and persistence screener in hypertensive patients at risk for cardiovascular events
Validation of data analysis with an FDA response in orthostatic hypertension
Adaptation of a heart study economic model in hypertension to Korea
Validation of the hypertension / dyslipidaemia treatment satisfaction survey
Hypotension
Defence of the use of the Orthostatic Hypotension Questionnaire (OHQ) to demonstrate treatment benefit and labelling claim in neurogenic orthostatic hypotension
Validation of the OHQ in neurogenic orthostatic hypotension using clinical trial data
Key opinion leader interviews on neurogenic orthostatic hypotension
Evaluation of the current measurement strategy in neurogenic orthostatic hypotension
Development of a payer value deck in immunology in ankylosing spondylitis, juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis
Payer value slides for a varicella vaccine
Payer value slides for immunology biosimilars
Payer value slide deck in muscle relaxation management
Payer value deck for an MMR and varicella vaccine
Payer focused value communication on rheumatoid arthritis
Payer material development for vaccines in hepatitis A, rotavirus gastroenteritis (RVGE), shingles, varicella and pneumococcal disease
Payer evidence dossier for a new psoriasis treatment
Payer value proposition in rheumatoid arthritis
Update to payer materials in rheumatoid arthritis
Communications package in hereditary angioedema
Patient support programme, payer communication tool and briefing pack in immunology
Frequently asked questions deck in juvenile idiopathic arthritis
Frequently asked questions to support the introduction of a new biosimilar in immunology
Frequently asked questions for biosimilar policy in immunology
Frequently asked questions on an immunology biosimilar for rheumatoid arthritis
Workshop and FAQ development in immunology in ankylosing spondylitis, juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis
Literature and content searches for global value dossiers in dermatology and immunology
Structured literature review for allergy immunotherapy, including medication adherence compared to other treatments
Strategic literature review and gap analysis in systemic lupus erythematosus and lupus nephritis
Communication of a literature review on systemic lupus erythematosus and lupus nephritis
Literature review of unmet need in rheumatoid arthritis
Literature review and update to budget impact model in an immunology biosimilar
Targeted literature review in psoriatic arthritis patients with concomitant moderate to severe psoriasis
Health economics training and model training in immunology
Interactive model in immunology
Economic workshop in immunology
Economic evaluation of a workplace influenza vaccination in Russia
Total Brand FAQ deck and Total Brand Workshop in rheumatoid arthritis, prostate-specific antigen (PsA), psoriasis, ulcerative colitis, Crohn’s disease and ankylosing spondylitis
Updates to a US budget impact model for an immunology biosimilar
AMCP dossier, budget impact model and global value dossier development in immunology
Update for a core value dossier in uveitis
Early global value dossiers for a new monoclonal antibody in Crohn’s disease and psoriasis
Global value dossiers and budget impact models for biosimilars in ankylosing spondylitis, Crohn’s disease, inflammatory bowel disease, osteoarthritis, psoriasis and rheumatoid arthritis
Update to an AMCP dossier for an immunology biosimilar
Updates to a global value dossier, AMCP dossier and budget impact model on a rheumatoid arthritis biosimilar
Two competitor review decks in psoriatic arthritis and ankylosing spondylitis
Two competitor reviews in psoriatic arthritis
Competitor value story in rheumatoid arthritis
Competitor value story in psoriatic arthritis
Competitor review of two JAK inhibitors in rheumatoid arthritis
Kidney transplant pricing research
Development of launch materials in ankylosing spondylitis and psoriatic arthritis
HTA strategy in immunology (ankylosing spondylitis and psoriatic arthritis)
Payer interviews and message testing in psoriatic arthritis
Cross-therapy area value proposition alignment in immunology
Originator vs. biosimilar value proposition update in immunology
Regulatory support on SMC questions on psoriatic arthritis work
Product value insight evaluation and strategy in atopic dermatitis
Core value dossier on psoriatic arthritis
Objection handler in rheumatoid arthritis
Budget impact model on the costs of treating psoriasis
Budget impact model on a biosimilar in multiple immunology indications
Early value dossier with value message proposition in systemic sclerosis
Pricing research on kidney transplant in emerging markets
Identification of PRO measures suitable for implementation in phase III oncology and immunotherapy trials
Analysis of a PRO and resource utilization in systemic lupus erythematosus
Critical review of PRO instruments in systemic lupus erythematosus and fatigue and pain in rheumatic disease
Review of PROs in systemic sclerosis/scleroderma
Development of posters on the analysis of a PRO and resource utilization in systemic lupus erythematosus
Patient focused outcomes in amyloidosis: Exit interviews to capture the patient experience of systemic amyloidosis, treatment and clinical trial participation
Translation and linguistic validation of clinician assessments in ACEI-Angioedema
Communications on clinician assessments in ACEI-Angioedema
Measurement strategy to demonstrate efficacy of medical devices in patients with pigmented villonodular synovitis (PVNS) or tenosynovial giant cell tumour (dTGCT)
Strategic consultancy on physician attitudes and preferences regarding adult vaccinations
Regulatory support for the validation of a questionnaire for influenza vaccination
Demonstrating the value of antibiotic resistance testing software
Modification of the Eosinophilic Esophagitis Activity Index (EEsAI)
Development of a value dossier, health economic model and literature review in an infertility biosimilar to support pricing and reimbursement submissions in 15 EU countries
Workshop on the EU price strategy for a recombinant follicle stimulating hormone used for the treatment of infertility
Conference presentation of health economic data on infertility treatment
Pricing updates in Europe for a biosimilar hormone treatment for female infertility
Advisory board with two payers to appraise an infertility product for reimbursement
Value story and communications for an infertility study
Upgrade of current model-structure and sensitivity analysis in influenza
Adaptation of a cost effectiveness model for an influenza vaccine for Germany, Austria and Mexico
Two manuscripts on an influenza vaccine for patients at risk and patients over 65 years old in France
Conference poster on the cost effectiveness of adjuvant influenza vaccination in France
Update of a value dossier on an influenza vaccine
Cost-effectiveness analysis of an influenza vaccine
Modification of the SIR dynamic model to the SEIR model for the USA and Italy
Modelling of influenza coverage rates
Communication of influenza coverage rates within the European Union
Book chapter written on the economics of influenza
Review of influenza vaccine uptake data
Updating an economic model of influenza vaccination (phase 1) – update of a model in patients aged over 65 years in France and the UK
Economic evaluation of a workplace influenza vaccination in Russia
Communication of the economics of an influenza vaccine
Interactive model on influenza
Adaptation of an influenza vaccine model to Belgium
Positioning paper on influenza
Economic value dossiers for influenza vaccines in a) an unprimed paediatric population and b) a primed school age population (intranasal delivery) including literature review, gap analysis and recommendations
Literature research and reporting on epidemiology and the economic burden of influenza B in Japan
Modification of a SIR dynamic model to a SEIR model for the US and Italy
Dynamic model to inform internal decision making regarding pandemic influenza
Regulatory support for the validation of a questionnaire for influenza vaccination
Survey of the impact of allergy on sleep (including literature review and HCP interviews)
Value communication support for an insomnia study
Value communication support for a systematic literature review in insomnia
Global value dossier and AMCP dossier in insomnia
Systematic literature review of real world evidence in insomnia
Literature review and report update in insomnia
Advisory panel in insomnia
Targeted literature review in Alzheimer’s disease and associated insomnia
Manuscript on a publication of a systematic literature review in insomnia
Review of PROs in insomnia
Cognitive debriefing of the daytime insomnia symptom scale and FDA support
Strategic consulting in insomnia
Validation of a primary insomnia functioning questionnaire
PRO strategy in insomnia
Manuscripts on the development and validation of the Sleep Impact Scale (SIS) in insomnia
Support on translation of the SIS in insomnia
Communications on the SIS in insomnia
Support on the adaptation of the SIS into three languages
Support on linguistic validation of the SIS in insomnia
Investigator meeting, review and presentation of slides on the Functional Outcomes of Sleep Questionnaire (FOSQ) and Work Limitation Questionnaire (WLQ)
Validation of the FOSQ in insomnia
Development of a conceptual framework and endpoint model in insomnia, plus qualitative patient interviews to confirm the validity of the conceptual framework and the psychometric validation of the final conceptual framework
Consultation on study design and interpretation of data on insomnia
Advisory panel in sleep disorders
Quality of life questionnaire in sleep disorders
Modification to the Sleep Impact Questionnaire following FDA review
Validation and linguistic adaptation of a sleep questionnaire
Linguistic validation of the Fatigue Impact Scale (FIS) into Argentinean Spanish, Austrian German, South African English, Norwegian and Afrikaans
Evaluation of the potential for a satisfaction claim for sleep disorders
Development of a PRO instrument for measuring mood swings and sleep problems resulting from vasomotor symptoms during the menopause
Evaluation of existing documentation and recommendations for psychometrically validating the modified Daytime Insomnia Symptom Scale (mDISS)
Scenario model in sleep disorders
Development of a sleep measure in different conditions
Report of sleep problems in fibromyalgia
Content validation of the modified Daytime Insomnia Symptom Scale (DISS) and the Sleep Impact Questionnaire event log
Manuscript on validation and efficacy results in insomnia
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