Endocrinology and metabolic diseases

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

Cushing’s disease

  • Input into PRO analyses for Cushing’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

Diabetes

  • 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
  • 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
  • e-v@luate EVIDENCE platform development for 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

Diabetes-related conditions/complications

Diabetic neuropathy

  • 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

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

Glucose transporter type 1 deficiency syndrome

  • Qualitative research to explore and support the assessment of the patient experience and impact of functioning of movement disorders in glucose transporter type 1 deficiency syndrome, and literature review in absence seizures

Growth hormone deficiency

  • Strategic literature review to select PRO for a paediatric growth hormone deficiency trial
  • Establishing support of content validity for the modified Injection Pen Assessment Questionnaire (IPAQ) in growth hormone deficiency
  • Injection Pen Assessment Questionnaire (IPAQ) field study in growth hormone deficiency

Homocystinuria

  • Health economic analysis for SMC resubmission in homocystinuria

Long-chain fatty acid oxidation disorders

  • Qualitative research to explore and support the assessment of the patient experience and impact on functioning of long-chain fatty acid oxidation disorders
  • Qualitative interviews on long-chain fatty acid oxidation disorders

Multinodal goiter

  • PRO endpoint review in multinodal goiter
  • Cognitive debriefing on quality of life in multinodal goiter
  • Qualitative data analysis and FDA support in multinodal goiter