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
Manuscript publication on a monthly contraceptive device
Development of a PRO strategy in oral contraceptives and gynaecological therapies
Modification, development and validation of an existing tool in order to explore satisfaction and tolerability for an intrauterine device (IUD) versus oral contraceptives
Modification of the EVAPIL-R in order to explore tolerability for an intrauterine system (IUS) versus an implantable contraceptive
Linguistic validation of the EVAPIL-R questionnaire on tolerability of oral contraceptives
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
Consultancy support for a clinical trial statistical analysis plan (SAP) in Cushing’s disease
Publication support and consultancy associated with patient-reported outcomes data for a trial in patients with Cushing’s disease
Consultancy and support associated with proposed analysis, communication and regulatory submission of patient-reported outcomes data for a trial in patients with Cushing’s disease
Development of an online therapy tool for depression along with a landscape analysis, structured and grey literature review, local language literature review, gap analysis, local language payer interviews and clinician interviews
Literature review and advisor feedback on the burden of illness, clinical and economic outcomes in US patients receiving adjunctive treatment for major depressive disorder
Literature review of the burden of depression in haemodialysis patients (in chronic kidney disease)
Literature review and sourcing of UK unit costs in depression
KOL interviews and Delphi method to estimate the direct health care costs of treating patients with treatment-resistant depression
Delphi method to estimate healthcare resource utilisation in major depressive disorder (MDD) with suicidal ideation
Delphi study cost estimates for healthcare resource utilisation in treatment-resistant depression
Delphi panel to estimate costs associated with major depressive disorder with suicide ideation (MDSI)
Delphi panel in depression
Manuscript and content validity of a PRO measure in major depressive disorder
Validation of the Children’s Depressions Rating Scale – Revised (CDRS-R) in Japan
Translation of the CDRS-R manual
PRO dossier on major depressive disorder for EMA submission
Development of an EMA technical document for PROs in depression
Instrument review and development of an EMA technical document to support patient-reported health-related quality of life labelling claims in depression
Communications on PRO clinical trial data and a literature review on depression
Development of a manuscript and presentation based on clinical trial PRO data in depression, primarily focused on interpretation of treatment
Validation and treatment effect analysis of the Sleep Impact Scale (SIS) in major depressive disorder
Review of PRO and CRO measures in severe depression
Selection of a PRO for depression in multiple sclerosis (MS)
Linguistic validation of a quality of life questionnaire on depression into UK English
Manuscript on validation and efficacy results in depression
Critical review of economic models, development of initial economic model structure in excel, development of budget impact model and publication in type 2 diabetes
Budget impact models for a biosimilar in type 1 and type 2 diabetes mellitus
Budget impact model for payer discussions in diabetes
Innovative budget impact model in type 2 diabetes
Communication on a formulary pack for medication in type 2 diabetes
NICE submission and SMC submission for an injectable drug for treatment of type 2 diabetes
SMC submission dossier for a treatment for type 2 diabetes
Payer strategy analysis of literature search results in type 2 diabetes
Payer value proposition and communication for a new remote patient monitoring platform in diabetes
Payer value deck in diabetes
Payer value slide deck for a biosimilar in diabetes
Payer communications in diabetes using data from the short form health survey (SF36)
Costing of pre-diabetes care in the US
Development of abstracts, posters and a manuscript on the critical review of economic models in diabetes
Global value dossier, AMCP and accompanying slide sets for an insulin biosimilar
Global value dossier updates, AMCP dossier updates and literature review in diabetes
Targeted literature review of the burden of type 2 diabetes mellitus
Systematic literature analysis on GLP1 receptor agonists in type 2 diabetes
Systematic literature analysis abstracts and white paper development on GLP1 receptor agonists in type 2 diabetes
Willingness to pay research in the UK, France and Germany in type 2 diabetes mellitus
e-v@luate EVIDENCE platform development for diabetes
e-v@luate platform for a payer value deck in type 2 diabetes
Manuscript on the barriers to intensification of insulin treatment in patients with type 2 diabetes in the Netherlands
Review of an Iranian manuscript on the cost of diabetes
Burden of disease in diabetes: Developing journal and conference publications based on market research data
Scientific communication for a time trade off (TTO) study in diabetes
Scientific communication of a Swedish cost-effectiveness analysis in diabetes
Manuscript on patient preference and willingness to pay in diabetes for South Africa
Scientific communications for a diabetes patient preference study in the UK
Scientific communications on a bolus insulin dosing study
Data collection for the use of long-acting insulin in the UK
Analysis and summary of outputs of client research with key opinion leaders to support reimbursement submissions and internal communications in diabetes mellitus (type 1 and 2)
Key opinion leader testimonials report and German data update in diabetes mellitus (type 1 and 2)
Key opinion leader testimonials poster in diabetes
Willingness to pay utility study in diabetes
Scientific communications for a willingness to pay study in diabetes
Frequently asked questions in diabetes
Posters regarding long acting insulin usage
Attendance at and strategic input into a diabetes workshop
Content validation of the paediatric quality of life questionnaire (PEDSQL) for type 1 diabetes mellitus
PRO selection, implementation, analysis and reporting on a low carbohydrate (CHO) trial in type 2 diabetes
Exploratory analyses and slide deck for a CHO trial in type 2 diabetes
PRO selection, implementation, analysis and reporting in type 2 diabetes mellitus
Gap analysis, endpoint model and FDA recommendations in type 2 diabetes
Recruitment and cognitive debriefing of three patients with type 2 diabetes
Indirect comparison of a treatment in type 2 diabetes
Systematic review of two treatments for type 2 diabetes
Validation of a hypoglycaemia questionnaire in type 2 diabetes
Development and validation of a PRO measure of hypoglycaemia, weight gain, tolerability and compliance in type 2 diabetes
Blind data review of a clinical trial in type 2 diabetes
Clinical trial analysis of a dose ranging study in type 2 diabetes mellitus
Analysis of PROs in two clinical trials in type 2 diabetes mellitus
Analysis of changes in HbA1C and health-related quality of life (HRQoL) in type 2 diabetes
Analysis of hypos versus no hypos in type 2 diabetes mellitus
Post-hoc analysis of clinical trial data: Linking clinical outcomes to PRO outcomes in type 2 diabetes mellitus
Biostats training and SAS program development for EQ-5D training in type 2 diabetes mellitus
Development of a dossier on the novel hypo instruments in type 2 diabetes mellitus
HEOR strategy support and study development in type 2 diabetes mellitus
Patient interviews in type 2 diabetes for development of a new PRO measure
Strategic literature review in type 2 diabetes
Literature review and development in type 2 diabetes
Consultation on a market research study on patient perceptions of pre-filled insulin pens
PRO analysis of a diabetes pre-post meal study
Gap analysis to identify the most responsive diabetes PRO measure for clinical trials
Validation of a revised symptom checklist in diabetes
Validation of the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) for diabetes in Japan
Cognitive debriefing on the perceptions about medications diabetes questionnaire (PAM-D)
Development of a manuscript on patient perceptions of prefilled insulin delivery devices
Database evaluation of costs and outcomes of diabetes treatment
Linguistic validation of the Diabetes Symptom Checklist-Revised (DSC-R) into UK English
Burden/cost of illness analysis of patient preference for once-weekly treatment in diabetes
Literature review examining the benefits of memory function on treatment adherence in diabetes
Development of a PRO strategy in diabetes
Evaluation of the potential for a satisfaction claim in an insulin product
Psychometric validation of a paediatric satisfaction instrument in diabetes
Analysis of a prevention clinical trial in diabetes
Strategic consulting and training in diabetes to support a client
Analysis of a patient qualitative assessment of a diabetic treatment after Ramadan
Analysis of clinical trial PRO data to assess patient-perceived and individualised benefit/risk of diabetic treatment
Linguistic validation of the Norfolk Quality of Life (QoL) questionnaire in diabetic neuropathy
Competitive analysis and burden of illness in diabetic peripheral neuropathy
Literature review of PROs and endpoints of pain in peripheral diabetic neuropathy
PRO assessment in diabetic peripheral neuropathy
Validation study of the modified version of the Brief Pain Inventory – Short Form (mBPI-SF), MOS-S and 3 single item questions in diabetic peripheral neuropathy
Gap analysis and strategic recommendation for PRO and market access studies in diabetic peripheral neuropathy
Consultancy on the validity of the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale for use in painful diabetic neuropathy patients
Interview study to understand the experience of walking pain among patients with diabetic peripheral neuropathy
Analysis of diabetic neuropathy
Retinopathy
Value messages and objection handlers for anti-vascular endothelial growth factor therapy (anti-VEGF) treatment in diabetic retinopathy and retinopathy of prematurity
Hypoglycaemia
Scientific communication on the prevalence and cost of severe hypoglycaemic events in Denmark
Slide deck on hypoglycaemia in diabetes
Study poster on Hypoglycaemia in Insulin Treated (HIT) patients
Manuscripts reporting the findings of the HIT Study on hypoglycaemia in diabetes
Manuscript reporting hypoglycaemia data for the HIT survey in the Netherlands
Three manuscripts for treatment of hypoglycaemia
Interactive slide deck presentation of hypoglycaemia study results
Abstract and manuscript reporting analyses from a hypoglycaemia study in the UK
Two manuscripts reporting specific country analyses from a hypoglycaemia study (Austrian and Finnish)
Manuscript reporting specific country analyses from a hypoglycaemia study (Denmark)
Scientific communication and presentation of data from the cross EU HIT study in hypoglycaemia
Diabetic macular edema
Rapid payer research to inform investment decisions in diabetic macular edema
Cost-effectiveness model to inform investment decisions in diabetic macular edema
Content validation of a visual function questionnaire in diabetic macular edema and retinal vein occlusion
FDA claim strategy and endpoint review for a visual function questionnaire in diabetic macular edema (DME) and retinal vein occlusion (RVO)
Review of PRO measures in diabetic macular edema
Interviews with patients with diabetes-induced edema in the USA
Diabetic foot infections
Diabetic foot ulcer support for FDA meetings
Psychometric validation of the Diabetic Foot Ulcer Scale (and Short Form) and the Short Form Health Survey (SF-36)
Cost effectiveness analysis model for Portugal on a treatment for bacterial diabetic foot infections
PRO strategy of a HRQoL claim for diabetic foot ulcers in vascular endothelial growth factor (VEGF)
Gastroparesis
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
Linguistic validation of the Norfolk Quality of Life (QoL) questionnaire in diabetic neuropathy
Competitive analysis and burden of illness in diabetic peripheral neuropathy
Literature review of PROs and endpoints of pain in peripheral diabetic neuropathy
PRO assessment in diabetic peripheral neuropathy
Validation study of the modified version of the Brief Pain Inventory – Short Form (mBPI-SF), MOS-S and 3 single item questions in diabetic peripheral neuropathy
Gap analysis and strategic recommendation for PRO and market access studies in diabetic peripheral neuropathy
Consultancy on the validity of the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale for use in painful diabetic neuropathy patients
Interview study to understand the experience of walking pain among patients with diabetic peripheral neuropathy
Development of a COA strategy for Down’s syndrome in adults and children
Clinical meaningfulness of scores on the Vineland Adaptive Behaviour Scale (VABS-II), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and Clinician Global Impression (CGI) in Down’s syndrome
Strategic literature review to identify COA instruments to assess the concept of independence in Down’s syndrome
Qualitative interviews and development of a COA strategy for Down’s syndrome in adults and children
Subgroup analysis by chronological age of individuals with Down’s syndrome
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