Therapeutic area

Acne

  • PRO gap analysis and competitor review in acne vulgaris
  • PRO development in acne vulgaris
  • Concept elicitation interviews in acne vulgaris to reach saturation
  • Observational psychometric validation study in acne vulgaris
  • Single item validation and user’s manual in acne vulgaris
  • Mixed method evaluation of an acne vulgaris measure – racial equivalence in non-Caucasion subjects using existing data
  • Medical writing for development and validation of a PRO in acne vulgaris
  • Clinical outcome assessments in acne scars
  • Literature research and content validation in acne scars
  • Analysis, reporting and patient interviews PRO in acne vulgaris
  • PRO instrument review in acne
  • Content validity testing of and regulatory support for use of the PRE-FACE in acne vulgaris
  • Linguistic validation and translation of the PRE-FACE

Acromegaly

  • Payer value proposition, payer value dossier and cost effectiveness model in acromegaly
  • Landscape analysis of acromegaly patient registries
  • Adequacy of the Acromegaly Quality of Life Questionnaire (AcroQoL) as an endpoint in acromegaly: endpoint review & strategic recommendations
  • Analysis of PRO data to support clinical trial dissemination activities in acromegaly
  • Consultancy to review acromegaly protocol
  • Exploratory analyses in acromegaly

Actinic keratosis

  • Literature review and stakeholder interviews on payer decision drivers in actinic keratosis
  • Statistical analysis and data interpretation from a multinational observational study in actinic keratosis
  • Manuscripts on a treatment for actinic keratosis
  • Patient diary study and analyses in actinic keratosis
  • Reporting on a patient diary study on adherence to topical treatment in actinic keratosis
  • Update of a dossier and development of a value story slide set to support affiliate teams in the value of an actinic keratosis product
  • Update to a core value dossier and value messages on actinic keratosis
  • Communication of PRO analysis from a phase III trial in actinic keratosis
  • Communication tool and materials on treatment in actinic keratosis
  • Publication summaries on treatment for actinic keratosis
  • Reimbursement dossier for a treatment in actinic keratosis
  • Use of PROs and ClinROs to build the best evidence and optimise market access for actinic keratosis

Alcohol dependence

  • Analysis and report generation on the medical environment for treatment of alcohol dependence
  • Supporting the development of a strategic ‘road map’ to support a publication on the alcohol dependent population
  • Definition of the alcohol dependent population in Europe
  • Literature review to understand the diagnosis, management and referral procedures for alcohol dependency in Japan
  • High level consultancy for a PRO endpoint strategy in alcohol dependence and obsessive compulsive disorder
  • Literature research and analysis on the economic and PRO burden of alcohol dependence

Adenomyosis

  • Development of disease-specific modules for adenomyosis

Other allergic conditions

  • Structured literature review for allergy immunotherapy, including medication adherence compared to other treatments
  • Systematic literature review in allergy immunotherapy products
  • Survey of the impact of allergy on sleep (including literature review and HCP interviews)
  • Portfolio value proposition and literature review on allergy immunotherapy
  • Abstracts and posters for allergy immunotherapy compliance in allergic rhinitis
  • Cost effectiveness analysis of allergy immunotherapy products
  • Internal value communication deck on real world studies in allergic reactions
  • Analysis of phase II symptom data in a study of lactose intolerance
  • Development of a COA strategy to measure treatment side effects for peanut allergy treatments

Allergic rhinitis

  • Structured review of medication adherence in allergic rhinitis compared with other treatments for chronic conditions
  • Communications and manuscript on a survey of the impact of allergic rhinitis on sleep
  • Review of PROs and development of a patient-reported screening tool in allergic rhinitis
  • Preference questionnaire on allergic rhinitis spray devices
  • Comparative preference trial with an experience questionnaire in allergic rhinitis
  • Focus groups assessing patient experience with nasal spray in allergic rhinitis, analysis of results and development of a report on concept elicitation and cognitive debriefing
  • Literature research and communications on the burden of nasal blockage in allergic rhinitis
  • Validation of the preference module of the Experience with Allergic Rhinitis Nasal Spray Questionnaire (EARNS-Q), with revisions to an FDA briefing document on the development and validation of the EARNS-Q experience and preference modules
  • Manuscript on the development of the EARNS-Q
  • Regulatory support for the EARNS-Q

Alopecia

  • Gap analysis of PROs for the use of a drug to grow darker and longer hair on the scalp
  • Conference poster on a gap analysis in alopecia
  • Development and validation of a photographic assessment and symptom measure in alopecia
  • Development of a symptom and impact PRO in alopecia
  • Development of a treatment satisfaction module for alopecia
  • Brief statistical analysis synthesis and interpretation (photo guide) in alopecia
  • Patient interviews for the development of alopecia-related PRO measures
  • Observational psychometric validation study in alopecia
  • Dossier on PRO measures in alopecia
  • PRO dossier for Subject Self-Assessment of Alopecia (SSAA)
  • Observational psychometric testing study in alopecia
  • Single item analysis in alopecia
  • Development of PRO and ClinRO instruments for alopecia totalis and alopecia universalis
  • Review and provide input into the development of a data analysis plan, validation study, drafts and final report of a randomized controlled trial on alopecia medicine
  • Conceptual equivalence testing of alopecia ePROs
  • Cognitive debriefing of the revised Subject Self-Assessment (SSA) and Hair Growth Questionnaire (HGQ) with patients with androgenic alopecia
  • Psychometric analyses and regulatory support in the development of PRO and ClinRO instruments for alopecia areata patchy, universalis and totalis

Alzheimer’s disease

  • Advisory panel on Alzheimer’s disease
  • Critical analysis and report to support the widespread use of a combination therapy in Alzheimer’s disease
  • Analysis and report generation of widespread use of combination therapy in Europe for the treatment of Alzheimer’s disease
  • Summary report on EMA marketing organisation for a treatment in Alzheimer’s disease
  • Budget impact model in Alzheimer’s disease
  • Disutility study in Alzheimer’s disease
  • Disutility of caregiver burden associated with Alzheimer’s disease in Japan
  • Health state development for mild cognitive impairment in Alzheimer’s disease
  • Early payer value deck for Alzheimer’s disease
  • Targeted literature review in Alzheimer’s disease and associated insomnia
  • Development of additional caregiver burden items for the Resource Utilization in Dementia Questionnaire for Alzheimer’s disease
  • Literature research and analysis on the Alzheimer’s disease landscape in Japan
  • Conceptual framework for the Alzheimer’s Disease Caregiver Preference Questionnaire (ADCPQ)
  • Linguistic validation of the ADCPQ into Chinese
  • Validation of the Alzheimer’s disease caregiver preference questionnaire
  • Evaluation of quality of life in cognitively impaired Alzheimer’s disease patients
  • Review of the Alzheimer’s Disease Activity Scale-cognitive subscale (ADAS-Cog)
  • Development of a COA strategy for mild-moderate symptomatic Alzheimer’s disease
  • Development of a trial-specific caregiver satisfaction and preference questionnaire for a treatment for Alzheimer’s disease
  • PRO instrument development, qualification quantitative component of content validity stage and in-trial psychometric analysis stage in mild cognitive impairment
  • Review of the University of California San Diego Performance-based Skills Assessment (UPSA) in Alzheimer’s disease
  • Cognitive debriefing of the Alzheimer’s Disease Co-operative Study – Activities of Daily Living Inventory (ADCS-ADL) questionnaire
  • Analysis of an open label extension study in Alzheimer’s disease

Anaemia

  • NICE consultancy for a treatment for chemotherapy-induced anaemia
  • Statistical pharmacoeconomic analysis of patient level data for a treatment for anaemia following chemotherapy
  • Linking a cost utility assessment model with a budget impact model for treatment for anaemia in cancer
  • Phase II cognitive interviews and regulatory support in inflammatory anaemia in cancer
  • Evaluation of the PRO landscape using a systematic literature review on chemo-induced anaemia in oncology
  • Patient consultations on anaemia
  • General consulting agreement for iron treatment in anaemia

Angina

  • Gap analysis of PRO measures to substantiate labelling claims in angina trials of a drug-eluting stent (DES)
  • Cognitive debriefing interviews and item finalization for a PRO for microvascular angina (MVA)

Angioedema

  • Telephone consultation on angioedema
  • Strategic PRO and ObsRO consulting of an angiotensin converting enzyme (ACE) inhibitor induced angioedema clinical trial database
  • Cognitive debriefing interviews in ACE inhibitor induced angioedema
  • Investigator training for the ACE inhibitor induced angioedema investigator rating scale
  • Translation and linguistic validation of clinician assessments in ACEI-Angioedema
  • Communications on clinician assessments in ACEI-Angioedema

Anxiety

  • Validation of the SIS in anxiety
  • Manuscripts on the development and validation of the Sleep Impact Scale (SIS) in generalised anxiety disorder
  • PRO strategy in generalized anxiety disorder with functional digestive disorders / irritable bowel syndrome (IBS)

Artery diseases and high cholesterol

  • Literature review of burden of illness and cardiovascular risk group identification of symptomatic peripheral artery disease
  • Literature review and payer appraisals in peripheral artery disease
  • Budget impact and economic evaluation of a statin
  • Advisory board on arterial occlusive disease
  • Workshop communicating health economic data of an anticoagulant medication for deep vein thrombosis (DVT)
  • Development of a treatment satisfaction measure for an injectable low-density lipoprotein (LDL) cholesterol lowering medication
  • Costs for psychometric validation of the Injection-Treatment Acceptance Questionnaire (I-TAQ) in an independent observational study in hypercholesterolemia
  • Statistical consultancy to support use of the I-TAQ for a cholesterol-lowering medication
  • Production of a revised heart model for hypercholesterolaemia incorporating additional comments from country affiliates
  • Worldwide database analysis of statins and cholesterol levels
  • Probabilistic analysis of a statin model and advice on a pharmacoeconomic manuscript
  • Endpoint review for FDA-approved flushing claims in atherosclerosis

Arthritis

  • Manuscript and analysis on an anti-inflammatory treatment for arthritis
  • PRO literature review for two different anti-inflammatory drugs for the treatment of arthritis

Ankylosing spondylitis

  • Interactive cost-effectiveness model for a selective inhibitor treatment used for ankylosing spondylitis
  • Manuscript cost-effectiveness analysis of a treatment for ankylosing spondylitis in Norway
  • Workshop and FAQ development in immunology in ankylosing spondylitis
  • Development of a payer value deck in immunology in ankylosing spondylitis
  • Competitor review deck in ankylosing spondylitis
  • Total Brand FAQ deck and Total Brand Workshop in ankylosing spondylitis
  • Global value dossier and budget impact model for a biosimilar in ankylosing spondylitis
  • Competitor value story slide deck in ankylosing spondylitis
  • Payer slide kit in non-radiographic axial spondyloarthritis
  • Core value dossier in ankylosing spondylitis
  • GI tolerability endpoint white paper including literature and instrument reviews on ankylosing spondylitis

Juvenile idiopathic arthritis

  • Workshop and FAQ development in immunology in juvenile idiopathic arthritis
  • Development of a payer value deck in immunology in juvenile idiopathic arthritis
  • Frequently asked questions deck in juvenile idiopathic arthritis

Osteoarthritis

  • Global value dossier and budget impact model for a biosimilar in osteoarthritis
  • Literature review of PROs and endpoints of pain in osteoarthritis
  • Literature review to support the use of COA measures in osteoarthritis
  • Competitive assessment and burden of illness study in osteoarthritis
  • Review of endpoints for clinical trials in osteoarthritis
  • Instrument review and assessment strategy in osteoarthritis
  • Mixed treatment comparison of two treatments for osteoarthritis of the knee
  • Mode of administration validation study for an electronic diary in back pain for osteoarthritis patients
  • Development and cognitive debriefing on a patient global response to a treatment measure in osteoarthritis pain
  • Translation and validation of the revised Hopkins Verbal Learning Test for osteoarthritis
  • Translation and validation of an osteoarthritis diary
  • Development of a measure of disease flare in osteoarthritis patients
  • Patient interviews to capture disease burden and unmet treatment needs in hand osteoarthritis
  • Mode of administration equivalency and usability testing of COA instruments in osteoarthritis
  • GI tolerability endpoint white paper including literature and instrument reviews on osteoarthritis
  • Consulting on PRO analysis and study design of trials in osteoarthritis
  • Top up literature review of PROs in osteoarthritis
  • Gap analysis and review of PRO measures in osteoarthritis
  • Qualitative exit interviews to assess the patient experience of treatment and clinical trial participation among patients with osteoarthritis

Psoriatic arthritis

  • Payer dossier update in psoriatic arthritis
  • Support for a manuscript on a network meta-analysis in psoriatic arthritis
  • Systematic literature review and network analysis in psoriasis and psoriatic arthritis
  • Targeted literature review in psoriatic arthritis patients with concomitant moderate to severe psoriasis
  • Workshop and FAQ development in immunology in psoriatic arthritis
  • Development of a payer value deck in immunology in psoriatic arthritis
  • Competitor review decks in psoriatic arthritis
  • Competitor value story slide deck in psoriatic arthritis
  • Data checks and DEF amendments in psoriatic arthritis
  • HTA support regarding psoriatic arthritis submissions in Canada, Spain and the UK
  • Regulatory support on SMC questions on psoriatic arthritis work
  • Development and Drug Development Tools (DDT) qualification of a PRO measure to assess the symptoms of psoriatic arthritis
  • Core value dossier on psoriatic arthritis

Rheumatoid arthritis

  • Literature search, data extraction and report on rheumatoid arthritis
  • Cost-consequences manuscript on rheumatoid arthritis
  • Generating evidence to support the unmet need in rheumatoid arthritis
  • Measuring indirect and societal costs of morning stiffness in patients with rheumatoid arthritis
  • Manuscript on a treatment in rheumatoid arthritis
  • Review of an economic model to assess utility requirements for a treatment in rheumatoid arthritis
  • Utility study and economic model in rheumatoid arthritis
  • Review of European HTA requirements for treatment in rheumatoid arthritis
  • Adaptation of an economic model on treatment of rheumatoid arthritis for the USA
  • Value message testing for a biosimilar in rheumatoid arthritis
  • Objection handler in rheumatoid arthritis
  • Economic model on a treatment for rheumatoid arthritis
  • Budget impact model for a biosimilar in rheumatoid arthritis
  • Competitor review in rheumatoid arthritis
  • Competitor review of two JAK inhibitors in rheumatoid arthritis
  • Payer focused value communication on rheumatoid arthritis
  • Payer value proposition in rheumatoid arthritis
  • Frequently asked questions on an immunology biosimilar for rheumatoid arthritis
  • Literature review of unmet need in rheumatoid arthritis
  • Literature review and recommendations for rheumatoid arthritis
  • Utility study in rheumatoid arthritis
  • Competitor value story in rheumatoid arthritis
  • Competitor value stories for two treatments of rheumatoid arthritis
  • Manuscript on a budget impact model for a cross-indication biosimilar in conditions including rheumatoid arthritis
  • Core value dossier, value deck and objection handler in rheumatoid arthritis
  • Update to an AMCP dossier for a rheumatoid arthritis biosimilar
  • Global value dossier and budget impact model for a biosimilar in rheumatoid arthritis
  • Workshop and FAQ development in immunology in rheumatoid arthritis
  • Development of a payer value deck in immunology in rheumatoid arthritis
  • Total Brand FAQ deck and Total Brand Workshop in rheumatoid arthritis
  • Review of PROs and preparation and writing of a PRO briefing document for the FDA on the treatment of rheumatoid arthritis
  • Generation of evidence to support the unmet need in rheumatoid arthritis
  • Modified Delphi Panel to gain consensus in rheumatology (rheumatoid arthritis)
  • Development of a PRO strategy in rheumatoid arthritis
  • Qualitative research in rheumatoid arthritis
  • Poster and manuscript on an indirect comparison of biologic treatments for TNF-IR rheumatoid arthritis patients
  • Systematic review to explore minimal important differences in PROs for rheumatoid arthritis
  • Meta-analysis of joint structural deterioration over time in minimally treated rheumatoid arthritis patients with inadequate response to disease-modifying anti-rheumatic drugs (DMARD-IR)
  • Mixed treatment comparison of efficacy and safety of an immunosuppressant drug versus a TNF inhibitor drug in rheumatoid arthritis patients with DMARD-IR
  • Mixed treatment comparison of an oral drug used in the treatment of rheumatoid arthritis
  • Characterising and predicting treatment response to rheumatoid arthritis biologic therapy
  • Literature review of unmet need in rheumatoid arthritis
  • Mixed treatment comparison of a treatment for rheumatoid arthritis populations – DMARD-IR and MTX-naive patients
  • Q&A and mixed treatment comparison on a treatment for rheumatoid arthritis
  • Indirect comparison of a monotherapy treatment for rheumatoid arthritis patients with DMARD-IR
  • Face and content validity testing of a tiredness item in a sample of rheumatoid arthritis patients
  • Development and Drug Development Tools (DDT) qualification of a PRO measure to assess the symptoms of rheumatoid arthritis
  • Psychometric evaluation of a PRO in rheumatoid arthritis
  • Evaluation of fatigue in rheumatoid arthritis using a PRO instrument
  • Patient interviews on rheumatoid arthritis
  • Patient interviews to capture disease burden and unmet treatment needs in rheumatoid arthritis
  • Support in development and analyses of a patient support programme in indications including rheumatoid arthritis
  • GI tolerability endpoint white paper including literature and instrument reviews on rheumatoid arthritis
  • Top up literature review of PROs in rheumatoid arthritis
  • Development and Drug Development Tools (DDT) qualification of a PRO measure to assess the symptoms of rheumatoid arthritis