Backed by Bright Pharmaceutical Services experience since 2002.
Autoimmune & Inflammatory
Phase II–III experience in rheumatoid arthritis, lupus, psoriatic arthritis, ankylosing spondylitis, and inflammatory bowel disease. Complex protocol designs including biomarker-stratified cohorts, patient-reported outcome endpoints, and long-term extension studies.
Cardiovascular
Heart failure, atrial fibrillation, acute coronary syndrome, and lipid-lowering programs. Cardiac endpoint adjudication, Holter monitoring coordination, and device trial experience across implantables and interventional procedures.
Central Nervous System
Alzheimer's disease, Parkinson's disease, epilepsy, major depressive disorder, schizophrenia, and chronic pain. Experienced with complex rating scale training programs, centralized rater models, and early-phase CNS designs that require specialized site qualification.
Dermatology
Atopic dermatitis, psoriasis, alopecia areata, and other inflammatory skin conditions. Both topical and systemic biologics. Photographic endpoint management, EASI/PASI/IGA scoring standardization, and dermatology site network activation.
Endocrinology & Metabolic
Type 1 and Type 2 diabetes, obesity, thyroid disorders, and other metabolic indications. Continuous glucose monitor integration, IVGTT protocols, and lab standardization across international sites.
Infectious Diseases
Antiviral, antibacterial, antifungal, and vaccine trials. Experience with adaptive Phase II/III designs, DSMB interactions for safety-intensive programs, and rapid site activation for outbreak-response studies.
Internal Medicine
Hepatology (NASH/MASH, cirrhosis, HCV/HBV), nephrology (CKD, IgA nephropathy), and pulmonology programs. Liver biopsy coordination, renal endpoint adjudication, and spirometry standardization.
Ophthalmology
Age-related macular degeneration, diabetic macular edema, glaucoma, and dry eye disease. Specialized site qualification for ETDRS charts and OCT imaging, reading center integration, and intravitreal injection protocol management.
Respiratory
Asthma, COPD, idiopathic pulmonary fibrosis, and rare pulmonary diseases. Spirometry standardization (ATS/ERS guidelines), FeNO testing coordination, and exacerbation-based endpoint adjudication.
Women's Health
Obstetrics, gynecology, endometriosis, uterine fibroids, and hormone-related indications. Experience with reproductive endpoint studies, device-based interventions, and programs requiring specialized informed consent processes.
Specialty Populations
Medical devices (PMA and 510(k) pathways), in vitro diagnostics, pediatric studies, geriatric studies, ethnic bridging studies, and surgical interventions. Regulatory strategy and clinical evidence generation across FDA and international submissions.