Therapeutic Areas
Endocrine and Metabolic Disease Clinical Development Expertise
Overcoming complexities to bring more metabolic disease treatments to market successfully.
Metabolic and endocrine diseases are a rising therapy area focus for clinical research due to the high demand for novel therapies that are challenged with proving safety and efficacy. The development process is complicated and full of unknowns, and even the best metabolic therapeutic might not make it to the patients that need it, not because it does not work but because the design, data collection, and analysis were not done right.
At Veristat, we have assembled an extraordinary team of scientific-minded experts who have mastered the complexities of running metabolic disease trials. Our team has supported 300+ projects for endocrine/metabolic disorder treatments and the preparation of 30+ marketing applications - 60% of which have been approved or authorized so far!
Success with Lifestyle, Genetic, and Rare Metabolic Therapies
We strive to advance your novel metabolic therapies from Phase I-III clinical development to market with confidence.
Our experienced teams are poised to plan and implement these efforts quickly, providing:
- Development of regulatory strategy, expedited pathways, and regulatory agency interactions
- Clinical program planning, inclusive of statistical planning and analysis
- Agile patient recruitment strategies to support virtual trial and hybrid approaches
- Rapid deployment of clinical trial databases and data analysis and migration into CDISC formats
- Virtual, decentralized and remote clinical and medical site monitoring
- Writing of clinical trial, safety, and regulatory documents
- Preparation and defense of Marketing Applications – NDAs, BLAs, NDSs, MAAs, jNDAs, etc.
- Post-Marketing Pharmacovigilance and Safety Monitoring to ensure patient safety beyond regulatory approval
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300+Endocrine/Metabolic Projects |
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> 250Projects for infectious disease treatments and vaccines |
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> 70%Genetic Disorders |
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Explore Our Endocrine Experience
Get the right strategic consultation, clinical program implentation, regulatory approval registration, and post-marketing support for endocrine and metabolic therapies based upon our extensive first-hand knowlege.
Breadth of Therapy Indications |
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| Achondropasia | Gaucher Disease | Lipodystrophy |
| Adrenoleukodystrophy (ALD) and Thalassemia | Generalized Lipodystrophy | Lysosomal Acid Lipase (LAL) |
| Alpha-mannosidosis (AM) | Gout (Hyperuricemia) | Maroteaux-Lamy Syndrome |
| Anorexia | Growth Hormone Deficiencies/Abnormalities | Molybdenum Cofactor Deficiency |
| Bardet-Biedl Syndrome and Alstrom Syndrome | Hereditary ATTR (hATTR) Amyloidosis | Mucopolysaccharidosis type IIIB |
| Cerebral Adrenoleukodystrophy | Homocystinuria | Multiple Lysosomal Storage Disorders |
| Chronic Pancreatitis | Homozygous Familial Hypercholesterolemia (HoFH) | Non-Alcoholic Steatohepatitis (NASH) |
| Congenital Adrenal Hyperplasia | Hypercholesterolemia | Obesity |
| Diabetes | Hyperoxaluria | Pharmacodynamic Markers |
| Dyslipidemia | Hypertriglyceridemia | POMC deficiency |
| Fabry Disease | Hypoleptinemic Dysmetabolic Disorder | Pompe Disease |
| Familial Amyloid Polyneuropathy | Hypoparathyroidism | Pyruviate Kinase Deficiency |
| Familial Chylomicronemia Syndrome (FCS) | Immunoglobulin A (IgA) Nephropathy | Vasomotor symptoms (VMS) |
Learn More with These Resources
Newsletter
Is Your Trial Stuck?
Case Study
Preparing Data for the Marketing Authorization Application ...
Conference Presentation
Turning Sponsor/CRO Relationships into Partnerships for ...