Therapeutic area

Dry eye

  • Healthcare resource costing study for dry eye disease in the UK
  • Development of a user manual on the Impact of Dry Eye in Everyday Life (IDEEL) using FDA guidelines
  • Revision of a manuscript on an IDEEL questionnaire for submission
  • Poster documenting development of the IDEEL
  • Consultation on composite endpoints for dry eye
  • Development of PRO for dry eye
  • Validation of a PRO for dry eye
  • Topline literature review to confirm information relating to three COAs for dry eye

Duchenne muscular dystrophy

  • Gap analysis of clinical outcome assessments and natural history of duchenne muscular dystrophy
  • Qualitative interviews with patients, caregivers and clinicians to define a clinician global impression of change item for duchenne muscular dystrophy

Duchenne muscular dystrophy

  • Gap analysis of clinical outcome assessments and natural history of duchenne muscular dystrophy
  • Qualitative interviews with patients, caregivers and clinicians to define a clinician global impression of change item for duchenne muscular dystrophy

Dyslipidemia

  • Development of a manuscript from an existing report detailing an analysis already performed using an existing economic model in dyslipidemia
  • Creation of a global value dossier for a treatment for dyslipidemia

Dyspepsia

  • Payer value proposition in dyspepsia
  • Interviews in dyspepsia
  • Development of a briefing packet for a FDA Type C meeting for a primary endpoint in functional dyspepsia
  • Linguistic validation of the Severity of Dyspepsia Assessment (SODA) and Pain Treatment Satisfaction Scale (PTSS) questionnaires into UK English
  • Development of a PRO to assess the symptoms of functional dyspepsia for the purposes of labelling
  • Quantitative research in functional dyspepsia

Ear infections and acute otitis media

  • Value communication support in acute otitis media associated with respiratory syncytial virus (RSV)
  • Diary of a caregiver validation for ear infection using the standard methodology
  • Training and manuscripts on the acute otitis media caregiver diary
  • Quality of life impact of otitis media and associated productivity loss in Malaysia and South Korea

Eczema

  • Literature review to identify the chronic hand eczema population in the US
  • Regulatory support in chronic hand eczema
  • Development of a manuscript to communicate the patient experience of chronic hand eczema
  • Two abstracts to communicate the development of a conceptual model in chronic hand eczema

Emphysema

  • General consultancy on economics, quality of life and reimbursement in lung volume reduction surgery in emphysema

Endometriosis

  • Validation of ePRO endpoints and a regulatory dossier to support claims in endometriosis
  • Qualitative research in Europe and validation of ePRO endpoints to support product labelling claims in endometriosis
  • Development and validation of ePRO endpoints for use in endometriosis
  • Psychometric validation and communications for newly developed PROs in endometriosis
  • PRO instrument development in endometriosis
  • Manuscript on PRO development and validation in endometriosis
  • Endpoint validation and finalisation in endometriosis
  • Review of a revision of a psychometric validation report on endometriosis and in-person attendance at FDA meeting
  • Endometriosis symptom diary and impact scale communications strategy
  • Exploration of instrument scoring (following EMA CHMP advice), psychometric evaluation using data from clinical studies and development of instrument user manuals in endometriosis
  • Consultancy services for linguistic validation of an endometriosis symptom diary and endometriosis impact scale
  • Endpoint review and regulatory support regarding the suitability of the Biberoglu & Behrman Scale (B&B) and Endometriosis Health Profile-30 (EHP-30) for supporting US product labelling claims in endometriosis
  • FDA PRO dossier updates and the development of Endometriosis Symptom Diary (ESD) and Endometriosis Impact Scale (EIS) user manuals
  • Review of a briefing book concerning a compound in development for the treatment of pain and other symptoms arising from endometriosis
  • Face and content validity of a new measure to assess symptoms associated with endometriosis
  • Development and face and content validation of a diary to assess symptoms associated with endometriosis
  • Development of disease-specific modules for endometriosis

Eosinophilic esophagitis

  • Development and validation of a PRO measure in paediatric patients with eosinophilic esophagitis
  • Qualitative interviews to develop a symptom measure in adult patients with eosinophilic esophagitis
  • Re-analysis of qualitative data and cognitive debriefing interviews to create a symptom measure in esonophilic esophagitis
  • Analysis of a field trial on eosinophilic esophagitis
  • Cognitive debriefing and modification of the Eosinophilic Esophagitis Activity Index (EEsAI)
  • Modification of the Eosinophilic Esophagitis Activity Index (EEsAI)

Eosinophilic gastroenteritis

  • Evaluation of COA tools in eosinophilic gastroenteritis (EGE) and eosinophilic gastritis (EG) with additional longitudinal data collection

Epilepsy

  • Mapping the health economic evidence landscape for anti-epileptic treatments
  • Systematic literature review and mixed treatment comparison for a treatment in epilepsy
  • Abstract review for the systematic literature review and mixed treatment comparison investigating treatments in epilepsy
  • Value dossier for an anticonvulsant medication for use in epilepsy
  • Evidence synthesis and modelling for an anticonvulsant medication in epilepsy
  • SMC submission for an anticonvulsant treatment for epilepsy
  • Brief literature review in epilepsy and search of FDA and EMA websites
  • Payer meeting and consultancy on an anti-epilepsy drug
  • Consultancy on an Italian model adaptation in epilepsy
  • Development of a US value dossier (meeting AMCP and WellPoint guidelines) and an expanded budget impact model on epilepsy
  • Cost-effectiveness analysis of two different anticonvulsant medications as adjunctive therapy for adults with partial refractory epilepsy in the US
  • Mixed treatment comparison summary for epilepsy

Dravet syndrome

  • Development of a composite trial endpoint for Dravet syndrome
  • Interviews on the development of a composite trial endpoint for Dravet syndrome
  • Manuscript on the development of a composite trial endpoint for Dravet syndrome
  • Publication support to disseminate findings from interviews with caregivers of children with Dravet syndrome, and independent qualitative analysis of findings

Lennox-Gastaut syndrome

  • Cost utility analysis model for Lennox-Gastaut Syndrome
  • Training with the client to discuss the Lennox-Gastaut Syndrome economic model/report and payer submission
  • Eliciting utilities in Lennox-Gastaut Syndrome
  • Assistance with responding to questions from the AWMSG and SMC on Lennox-Gastaut syndrome

Erectile dysfunction

  • Development of a symptom and QoL questionnaire on erectile dysfunction
  • Manuscript on the development of a questionnaire on treatment satisfaction in erectile dysfunction
  • International psychometric validation of the total symptom score (TSS) questionnaire in erectile dysfunction
  • Linguistic validation of the Rosenberg Self-Esteem Scale (RSES) questionnaire for erectile dysfunction into UK English
  • Linguistic validation and cognitive debrief of a self-esteem and relationship questionnaire for erectile dysfunction
  • FDA dossier for PRO instruments measuring the impact and symptoms of erectile dysfunction
  • Patient interviews to support the development of an FDA dossier on an erection hardness score questionnaire
  • Review of excel tables and a regulatory document for a treatment for management of erectile dysfunction

Esophogeal cancer

  • Payer value deck in esophogeal cancer
  • Burden of disease deck in esophogeal cancer
  • Response to payer questions in esophogeal cancer
  • Clinical trial analyses to support HRQoL in oesophageal cancer
  • Reimbursement scenario analysis in oncology for 11 country adaptations and inclusion of esophageal cancers

Excess sebum (oily skin)

  • Development and validation of a questionnaire to assess patient’s satisfaction with treatment for oily skin (excess sebum)
  • Validation of the Excess Sebum Treatment Satisfaction Scale and the Patient Reported Excess Sebum Co-primary efficacy endpoint
  • Focus group sessions presentation on excess sebum
  • Cognitive debriefing interviews in excess sebum
  • Consultation on a methods study to validate primary and secondary endpoint measures in excess sebum
  • Initial psychometric validation of an oily skin questionnaire
  • Face and content validation of the oily skin PRO instruments in adolescents

Eyelash/eyebrow satisfaction

  • Development of a poster and manuscript for the validation of an eyelash satisfaction questionnaire in China
  • Development of an EMA PRO dossier for an eyelash satisfaction questionnaire
  • Validation of the EEM and ESS in eyelash hypotrichosis
  • Item-level validation for a questionnaire in eyelash health and satisfaction
  • Validation of the eyelash satisfaction questionnaire in Japan
  • Development of a PRO dossier for the 9-item eyelash satisfaction questionnaire for Japan
  • Translation and validation of an eyelash questionnaire in China
  • Gap analysis of PROs for the use of a drug to grow darker and longer eyebrows
  • Content testing and adaptation of the eyelash satisfaction questionnaire (ESQ-9) for eyebrows
  • Cognitive interviews on the eyebrow satisfaction questionnaire
  • User manual and single item validation in eyebrow satisfaction
  • Qualitative interviews to evaluate the psychological impact of the brow satisfaction questionnaire and to validate in a post-chemotherapy population

Fabry’s disease

  • Global value dossier in the treatment of Fabry’s disease
  • Strategic literature review in Fabry’s disease
  • Development of a PRO questionnaire to assess gastrointestinal symptoms of Fabry’s disease
  • Survey administration in an observational study to evaluate gastrointestinal symptoms of Fabry’s disease
  • Strategic consultancy on a protocol for Fabry’s disease
  • Consulting agreement and communication in Fabry’s disease
  • Strategic consultancy in gastrointestinal symptoms of Fabry’s disease
  • Cognitive debriefing of the Gastrointestinal Symptom Rating Scale Diarrhoea Domain in patients with Fabry disease

Facial wrinkling

  • Development and validation of a PRO measure in facial lines
  • Validation plan and FDA regulatory support for the Facial Wrinkling Scale
  • Poster production for two PRO measures of facial wrinkling to be presented at a dermatological conference
  • Development of a manuscript to report the results of a PRO measure in facial wrinkling
  • Validation of a PRO measure of facial line satisfaction
  • Qualitative interviews to support the concept of psychological impact on the facial line outcomes questionnaire
  • Cognitive interviews in facial line satisfaction
  • Validation of the subject facial wrinkle scale in China
  • Psychometric evaluation of a PRO in facial lines
  • Support in securing advice on marketing claims not currently in the FDA-approved product label for a cosmetic treatment for facial lines
  • FDA dossier on a cosmetic treatment for facial lines
  • EMA dossier on a cosmetic treatment for facial lines
  • Content validation of the subject-rated facial wrinkle scale for forehead lines
  • Cognitive debriefing of a ClinRO in facial lines
  • Cognitive debriefing of a PRO in facial lines
  • Validation of a skin / wrinkling module
  • Validation of questionnaires for facial lines in Japan
  • Validation of questionnaires for facial lines in China
  • Consulting for ClinROs and PROs in facial lines and hyperhidrosis
  • Content validation of the facial wrinkle scale
  • Review of PRO endpoints for use of a topical botulinum toxin in trials for the treatment of crow’s feet
  • Development of a PRO briefing document to support the facial wrinkling scale in crow’s feet
  • Qualitative analysis of patient interviews to identify how subjects describe the severity of crow’s feet
  • Cognitive debriefing of a PRO in glabellar lines
  • Preparation of a payer briefing document for a treatment for glabellar facial lines
  • Abstract and poster development for a glabellar line clinical program
  • Support in the linguistic validation of glabellar facial line PROs
  • Publication strategy of PROs in glabellar lines
  • Psychometric evaluation and regulatory strategy of PROs in glabellar lines
  • Consulting agreement for trial preparation and PRO endpoints in canthal lines
  • Evaluation of psychological impact using the facial lines outcome-11 questionnaire in forehead lines, glabellar lines and upper facial lines
  • Prescription Drug Marketing Act (PMDA) PRO dossier for a cosmetic program