Scientific Expertise
At PHT, we pride ourselves on our commitment to the integrity and success of our clients' clinical trials. We employ a comprehensive process of scientific review, which includes keeping the science of your clinical trial at the forefront of the planning process, as well as drawing upon the resources of our expert scientific team to design a reliable and user-friendly eDiary.
Technology in Support of Science
PHT understands that study sponsors know their science best - our expertise is developing scientifically responsible technology solutions that enable better and more conclusive clinical trials. This effort is led by three well-known and distinguished industry thought leaders:
- Steve Raymond, Ph.D. - Founder, Chief Scientific and Quality Officer
- Valdo Arnera, MD - General Manager, Europe
- Barbara Marino, Ph.D., RN - Director, Clinical Operations Scientific Advisor
Our science team is actively involved in every client study, advising on the technical best practices we have learned while respecting the sponsor's trial requirements and scientific goals. Dr. Marino has personally managed the design of more eDiaries than most ePRO providers have in aggregate, while Dr. Raymond and Dr. Arnera (who are also members of our Executive Management Team) regularly serve as featured speakers at ePRO, eSource, and regulatory industry conferences around the world. Review PHT's events schedule to find out where you can meet them next.
Indications of ePRO Success
PHT's ePRO solutions have been used to investigate safety and efficacy for numerous indications in all therapeutic areas. A selection of our experience:
| Therapeutic Area | Indication |
|---|---|
| Allergy | Allergic Induced Asthma, Allergic Rhinitis, Allergic Rhinitis/Asthma, Allergy, Allergy Birch, Allergy Cat, Allergy Dust Mite, Allergy Grass, Allergy Ragweed, Rhinoconjunctivitis, Seasonal Allergic Rhinitis |
| Behavior / Psych | ADHD, ADHD with Tic Disorder, Alzheimer's Disease, Bipolar Disorder, Depression, Generalized Anxiety Disorder, Mood Stabilization, Smoking Cessation, Weight Managment |
| Cardiovascular | Angina, Anti-Arrhythmia, Deep Vein Thrombosis, Dyslipidemia, Hemostasis, Niacin Induced Flushing |
| CNS | Chronic Pain, Fibromyalgia, Headache, Insomnia, Migraine, Multiple Sclerosis, Neuropathic Pain, Neuropathy/Neuralgia, Parkinson's Disease, Postherpetic Neuralgia, Restless Leg Syndrome, Spasticity, Weakness/Paralysis |
| Dermatology | Eczema, Psoriasis |
| ENT | Dental Pain, Dental Surgical pain |
| Endocrinology | Diabetic Neuropathy, Diabetes, Vasomotor Symptoms, Hot Flashes |
| Gastrointestinal | Abdominal Pain with Cramping, Acute Pain Hernia, Celiac Disease, Constipation, Crohn's Disease, Gastric Ulcer, Gastroesophageal Reflux Disease, Heartburn, Inflammatory Bowel Disease, Irritable Bowel Syndrome, Opioid Induced constipation |
| Genitourinary | Abdominal Hysterectomy, Dysmenorrhea, Endometriosis, Erectile Dysfunction, Female Sexual Dysfunction, Fibroids, Incontinence, Neurogenic Bladder, Overactive Bladder, Premature Ejaculation, Pregnancy Prevention |
| Immunology | Angioedema, Gaucher Disease, HAE Disease, Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Vaccine |
| Infectious Disease | Clostridium Difficile, Hepatitic C, Hepatitis B, Herpes, HIV, H1N1, Influenza |
| Oncology | Anorexia, Breast Cancer, Cachexia, Malignant Melanoma, Non Small Cell Lung Cancer, Pain, Pancreatic Cancer, Prostate Cancer |
| Orthopedic | Osteopenia, Arthroscopic Shoulder Surgery, Bone Fracture Repair, Bunionectomy, Osteoarthritis, Post Operative Pain, Chronic Lower Back Pain |
| Respiratory | Asthma, Bronchiectasis, COPD, Emphysema |
And the Questionnaire is...
PHT has implemented more standardized questionnaires and health related -quality of life (HRQOL) surveys than any other ePRO provider, We are constantly adding new questionnaires based on client demand; contact us for the list of questionnaires we have implemented. Recently, we have validated the Asthma Control Questionnaire (ACQ and ACQ-5), Asthma Quality of Life Questionnaire (AQLQ)and the Rhinitis Quality of Life Questionnaire with Professor Elizabeth Juniper for use on our ePRO System.
Scientific Advisory Board
PHT recognizes the value of access to expertise and has assembled an externally-staffed advisory board of leading academicians, scientists, technologists and clinical investigators to help you succeed. The Scientific Advisory Board is available on request to provide sponsors with comprehensive and multi-angle consultative services in areas including clinical trial design, psychometrics (e.g. design, selection and validation of questionnaires), statistical consulting, results interpretation, decision support and data mining.
Learn More about PHT's Scientific Expertise
Have you implemented the questionnaires I plan to use? What kinds of expert advice does your science team provide? Which therapeutic areas, indications and questionnaires work best with ePRO? Contact PHT for answers to these questions or any others you may have.
