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
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
Development of a value dossier, health economic model and literature review in an infertility biosimilar to support pricing and reimbursement submissions in 15 EU countries
Workshop on the EU price strategy for a recombinant follicle stimulating hormone used for the treatment of infertility
Conference presentation of health economic data on infertility treatment
Pricing updates in Europe for a biosimilar hormone treatment for female infertility
Advisory board with two payers to appraise an infertility product for reimbursement
Value story and communications for an infertility study
Cost utility analysis of hormone replacement therapy (HRT)
Observational study of HRT
Cognitive debriefing of a women’s health screening tool
Consultancy on FDA documents on the menopause
Psychometric validation of the SAM/WSM using PNS validation study data
Literature review of HRT outcomes in the menopause
Development of a conceptual model for vasomotor symptoms in post-menopausal women
Trial of two drugs used to treat menopausal symptoms
Pilot testing of a paper hot flash diary and questionnaire on the menopause
Development of a PRO instrument for measuring mood swings and sleep problems resulting from vasomotor symptoms during the menopause
Development of a briefing document for measuring the impact of menopausal hot flushes
Development of a PRO for breast pain/pressure and vaginal bleeding/spotting for female patients on HRT
Manuscript reporting results of qualitative work to support development of a breast pain daily diary (BP-DD) and vaginal bleeding/spotting daily diary (VBS-DD)
Visual aid and flyer for a drug in pelvic organ prolapse
Value demonstration and communication of UK burden of nausea and vomiting during pregnancy
Report on the humanistic burden and psychometric validation of the breast pain and vaginal bleeding e-diaries, the breast sensations and vaginal bleeding impact questionnaires and the treatment satisfaction questionnaire
FDA meeting on a functioning claim for cyclical mastalgia
Psychometric analysis of quality of life questionnaires in women’s health
Data entry and analysis of SMILE data received from a clinical trial in women’s health
Generation of utility measures in women’s health and rescoring of the Women’s Health Questionnaire (WHQ)
Patient preference and utility study for an injectable hormone treatment
EVAPIL-R communications and strategic advice regarding the modification of existing PRO measures in women’s health
Development of a PRO best practices document – interactions with international regulatory and HTA agencies in women’s health
Analysis of a menstrual distress questionnaire in pre-menstrual syndrome (PMS) using trial data
Consultation on a response to the FDA regarding the validation of a primary endpoint in pre-menstrual dysphoric disorder (PMDD)
Support of an endpoint dossier for regulatory submission in PMDD
Review and research of articles on PMDD criteria
Cross-validation of the Premenstrual Symptoms Screening Tool (PSST) and the Daily Record of Severity of Problems (DRSP) for use in patients with PMDD and PMS
Conference poster documenting the symptoms and impact of PMDD during the luteal phase and the appropriateness of the Daily Record of Severity of Symptoms Tool
Consultation on the development of a diary to assess uterine fibroids
Assessment of a minimal clinically important difference in a uterine fibroid symptom and quality of life questionnaire
Design and pilot testing of an ePRO in uterine fibroids
Regulatory and statistical support for an FDA claim in women with uterine fibroids
Development of disease-specific modules for fibroids
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