Gastrointestinal diseases

Clostridium difficile

Pre-budget impact analysis and economic advice for personalized medicine: approaches to diagnose and control clostridium difficile infections

Constipation

Market access consultancy in the treatment of chronic idiopathic constipation
Cognitive debriefing interviews for a paediatric constipation symptom diary
Development of a PRO strategy for paediatric chronic constipation
Development of PRO instruments assessing symptoms and health-related quality of life for paediatric patients with chronic constipation
Development of a primary endpoint to assess quality of life in paediatric constipation
Providing support in the design and set up of a paediatric functional constipation dose ranging study, updating the eCOA and incorporation of the eCOA into the trial, and support in performing psychometric validation using the trial data
Face and content validation of an e-diary to assess opioid-induced constipation and other gastrointestinal side effects in chronic non-cancer pain
Planning and execution of an advisory board to obtain feedback on the PRO strategy and plans for the phase III program for a treatment for opioid-induced constipation
Patient interviews to assess content validity of an instrument for use in opioid-induced constipation
Cognitive debriefing of 7-day recall period for the Patient Assessment of Constipation, Quality of Life Questionnaire (PAC-QOL) and Patient Assessment of Constipation Symptoms (PAC-SYM) in opioid-induced constipation
PAC-SYM and analysis of a skin patch containing an opioid pain medication
Review of patient diaries and PRO questionnaires for evaluating constipation in opioid-treated non-cancer pain
In-depth interviews, instrument development and cognitive debriefing related to measurement of opioid-induced constipation
Validation of a patient e-diary to assess opioid-induced constipation
Consolidation of results on the development of a bowel function diary for opioid-induced constipation
Endpoint model, conceptual framework, cognitive debriefing interview, saturation point and report on opioid-induced constipation
Cognitive debriefing of a PRO measure of paediatric chronic constipation
Long term safety study and participation interviews in chronic constipation
Consultation on a project on chronic constipation
Manuscript based on a literature review in paediatric constipation
Literature review on chronic constipation
FDA meeting on chronic constipation
Interviews with clinicians to understand diagnoses of paediatric chronic constipation

Crohn’s disease

Early global value dossiers for a new monoclonal antibody in Crohn’s disease
Literature review and recommendations for Crohn’s disease
Payer objection/question responses in Crohn’s disease
Structured literature review and value dossier updates in a biosimilar for Crohn’s disease
Payer value deck for a biosimilar in Crohn’s disease and paediatric Crohn’s disease
White paper on PROs in Crohn’s disease
FDA briefing document on Crohn’s disease
Advisory board on a treatment for Crohn’s disease
Development and implementation of a plan to deliver economic and outcomes evidence to support commercialisation of a treatment for Crohn’s disease in key markets
US database analysis to support a pharmacoeconomic model in Crohn’s disease in the US
PRO review in Crohn’s disease
PRO gap analysis and initial PRO dossier development in Crohn’s disease
Support in development and analyses of a patient support programme in Crohn’s disease

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

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

Gastroesophageal reflux disease and gastric reflux

Literature review of COA endpoints in paediatric gastric reflux
Activities to confirm the cross-cultural validity of a conceptual model in paediatric gastro-oesophageal reflux disease (GERD)
Manuscript on the simultaneous development of the Paediatric GERD Caregiver Impact Questionnaire (in gastroesophageal reflux disease) in American English and American Spanish
Cognitive debriefings in patients with GERD
De-identification of transcripts in GERD
Content validity and pilot testing of the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-DD) in the UK and five European markets

Gastroparesis

Testing of the validity of gastroparesis symptom questions
Sub group analysis of gastroparesis patients interviewed in exploratory phase, Rasch analysis and PCA on a 5 item scale
Phase III statistical analysis plan and regulatory consulting on the gastroparesis symptom assessment (GSA) for submission
Review of a protocol amendment for a phase II gastroparesis study which includes the Care-giver Strain Index (CGSI) as a primary endpoint
Review of protocol on a phase II study of subjects with severe gastroparesis due to diabetes mellitus
Cognitive debriefing of a symptom measure of gastroparesis in diabetics and standalone validation study

Inflammatory bowel disease

Pre-budget impact analysis in personalised medicine (biomarkers) for inflammatory bowel diseases

Irritable bowel syndrome

Literature review of PROs and endpoints of pain in irritable bowel syndrome (IBS)
Literature review and manuscript on IBS
Patient interviews and qualitative work on IBS
Analysis of focus group data in IBS
Productivity workshop in IBS
Focus groups in IBS
Consulting for PROs for a treatment used in IBS
Prospective outcomes study in IBS
PRO strategy in generalized anxiety disorder with functional digestive disorders / IBS
Mixed methods analysis of cognitive debriefing data in irritable bowel syndrome with constipation or chronic constipation (IBS-C/CC)
PRO dossier in IBS-C
Independent analysis, evidence saturation and report on 30 interviews in IBS-C
Development of a PRO strategy for paediatric IBS-C
Literature review in IBS-C
Manuscript based on the findings of the exit interview study of patients taking a treatment for IBS-C within a long term safety study
Exploratory analysis of PRO data to support the interpretation of change on IBS-C abdominal symptom endpoints
Development of PRO instruments assessing symptoms and health related quality of life for paediatric patients with IBS-C
Testing and cognitive debriefing interviews for a diary in paediatric symptoms of IBS-C/CC
Network meta-analysis of treatments for IBC-C/CC
Conference poster and debriefing of paediatric IBS-C
Cognitive debriefing of a PRO measure of IBS-C symptoms
Long term safety study and participation interviews in IBS-C
Consultation on a project on IBS-C
FDA meeting on IBS-C
Interviews with clinicians to understand diagnoses of paediatric IBS-C
Development and validation of a primary endpoint to support an indication in irritable bowel syndrome with diarrhoea (IBS-D)
Psychometric validation of a newly developed PRO for IBS-D
Analysis of qualitative data on IBS-D from focus groups
Psychometric validation for a newly developed PRO in IBS-D
Development of a PRO measurement dossier on IBS-D for submission to the FDA
Development of a PRO instrument assessing symptoms in paediatric patients with IBS-D
Assistance with preparations for an FDA type C meeting on IBS-D
Development and validation of a primary endpoint for an FDA submission in IBS-D
Selection of PROs for IBS-D, regulatory strategy and support
Phase II data analysis: Interim and final psychometric testing in IBS-D
Manuscript on IBS-C and IBS-D

Other gastrointestinal experience

Development of a global value dossier and budget impact model for capsule endoscopy for colonoscopy
Global value dossier for a therapy device in refractory ascites
Biosimilar payer communications in gastroenterology
Health economics support package in gastroenterology
Value proposition on a treatment for heartburn and indigestion
Cognitive debriefing and content validation of the diarrhoea symptom assessment measure
Cognitive debriefing of the Gastrointestinal Symptom Rating Scale Diarrhoea Domain in patients with Fabry’s disease
Support with interviews in paediatric vomiting
Managing patients with stoma: Adaptation of a Quality of Life Index (QLI) questionnaire to current needs for colostomy patients
Consultation and conduction of a discussion panel at the European Council of Enterostomal Therapy conference
Development of a manuscript based on modification of an ostomy study
Language validation interview for an ascites impact questionnaire
General consulting agreement in gastrointestinal assessments
Training work on post-operative nausea and vomiting
Strategic consultancy in gastrointestinal symptoms of Fabry’s disease
HEOR consulting services including clinical outcomes and regulatory approach

Post-operative ileus

Literature review of the management of post-operative ileus in Europe
Analysis of the burden of illness of post-operative ileus in 4 European countries
Analysis of post-operative ileus in a complicated population using country-specific databases

Rotavirus

Payer value deck in adult rotavirus gastroenteritis
Payer material development for vaccines in rotavirus gastroenteritis
Payer value deck in adult rotavirus gastroenteritis (pneumococcal conjugate vaccination)
Payer value deck on the humanistic burden of rotavirus
e-v@luate platform on a vaccine for rotavirus
Manuscript, economic model and literature review on the burden of rotavirus and the impact of vaccination on health care utilization in Europe

Short bowel syndrome

Initial market access evidence assessment for a new orphan drug for short bowel syndrome
UK patient disease journey in short bowel syndrome

Ulcerative colitis

Payer objection/question responses in ulcerative colitis
Manuscript reporting the literature review and qualitative research project with ulcerative colitis subjects
Workshop and FAQ development in immunology in ulcerative colitis
Development of a payer value deck in immunology in ulcerative colitis
Payer value deck for a biosimilar in ulcerative colitis
Structured literature review and value dossier updates in a biosimilar for ulcerative colitis
PRO gap analysis and initial PRO dossier development in ulcerative colitis
Support in development and analyses of a patient support programme in ulcerative colitis