Our multidisciplinary patient-reported outcomes (PRO) team of psychometricians, survey researchers, and health outcomes experts utilize a wide range of quantitative and qualitative methodologies to help pharmaceutical and biotech companies assess the impact of diseases on patients and demonstrate the drug benefits most important to them. The results of these assessments provide payers, providers and regulators with a better understanding of the patient experience and perspective, which supports both product development and post-marketing strategies.
We routinely conduct PRO studies that assess:
Health-related quality of life (HRQoL)
Patient satisfaction
Medication adherence
Primary efficacy endpoints or patient symptoms
Work productivity
Patient preferences
Functional status
The information gained from these studies can demonstrate the benefits of a therapy, provide important evidence for formulary acceptance, and contribute to overall value messages to better position your product in the marketplace.
A Suite of PRO Services
The broad range of survey research/data collection, psychometric, and related PRO services we offer to assist your needs include:
Expert consulting on FDA guidelines, endpoint selection, and study design
Developing and validating new PRO measures
Psychometric evaluation of existing instruments for reliability, responsiveness, validity, and dimensionality
PRO instrument review and development of optimal measurement strategies
Administering patient, caregiver, and physician surveys (web-based, mail, and phone)
Designing case report forms that measure clinical trial outcomes
Statistical analysis of PRO data
Conducting focus groups and qualitative interviews
We leverage our resources to identify and access target populations, including low-prevalence and hard-to-reach populations, and use basic to highly sophisticated methodologies to conduct your study, including:
Electronic data capture (EDC) devices
Web-based data collection systems
Hand-held diaries
Interactive voice response systems (IVRS)
Paper or scanned forms
In-person interviews and focus groups
Deliverables
Depending on your unique needs, your PRO deliverables may include:
PRO instruments and measurement strategies for use in clinical trials
Documentation to support labeling claims
Manuscripts and abstracts
Study reports
Training materials
Conference posters and presentations
Therapeutic Experience
For your benefit, we offer a variety of services that complement our health economics work:
Women’s Health
•
Contraception
•
Menopause
•
Endometriosis
Urology
•
Overactive bladder
•
Incontinence
Sexually Transmitted Diseases
•
HIV/AIDS
•
Herpes
•
Human papillomavirus (HPV)
Obesity
Chronic Pain
Gastrointestinal (GI) Disorders
•
Dyspepsia
•
Irritable bowel
syndrome (IBS)
•
Constipation and
diarrhea
Respiratory
•
Bronchitis
•
Asthma
•
Chronic obstructive pulmonary disease
(COPD)
Dermatology
•
Acne
•
Alopecia
•
Psoriasis
Cardiovascular Disease
Psychiatry
•
Attention deficit disorder
•
Anxiety
•
Bipolar disorder
•
Depression
•
Schizophrenia
Sleep Disorders
•
Insomnia
•
Restless legs syndrome
Sexual Function
•
Erectile dysfunction (ED)
•
Low libido
•
Female sexual dysfunction
Oncology
Related Services
For your projects that may have cross-functional requirements, we also offer the following complementary services:
