Fountain Medical Development is a clinical contract research organization (CRO) offering a full range of ICH GCP compliant clinical research services in China, US, Japan, and Europe. FMD has extensive global experience in multiple therapeutic areas. The company has completed dozens of registrations trials which supported marketing authorization applications in US and Europe.
Our people is the basis of our success. The 1,700+ professionals are dedicated and diverse. At any given moment, at least 3 languages are spoken in our 20 offices in Asia, US, and Europe.
FMD is on the forefront of the paradigm shift in global clinical development. The regulatory reform in China has the potential to fundamentally change how an innovative therapy is developed. FMD is on the frontline building and shaping the future.
FMD is large enough to serve 7 out the 10 largest Pharma companies, and nimble enough to customize to the needs of startup firms.
In the US and Europe, FMD is doing business as FMD K&L. In China, we operate under the name FMD. Whatever the names are, the company is managed globally by a seasoned senior management team comprised of industry veterans.
DP Clinical, Inc. is a privately held Contract Research Organization (CRO) specializing in neurology/CNS (including spinal cord injury), oncology, ophthalmology, infectious disease/vaccines, and rare disease Phase I-IV clinical programs. DP Clinical provides a full complement of clinical trial services to pharmaceutical, biotech, and medical device companies including trial management, monitoring, data management, biostatistics, regulatory, safety monitoring and reporting, and medical writing. Since 1994, we have worked for clients of all sizes — small to large pharmaceutical and biotech companies, academic research institutions, and government sponsors.
DP Clinical provides integrated trial solutions as well as specific service components based on sponsor need. Our comprehensive services include:
• Project management
• Clinical trial monitoring
• Data management
• Pharmacovigilance and safety
• Regulatory affairs
• Quality assurance
• Medical writing
VetPharm, Inc. is a full-service contract research organization (CRO) dedicated exclusively to animal health. It offers a complete menu of pilot/pivotal/post-marketing clinical trial support services, including protocol development, data form design, investigator recruitment, site qualification, enrollment enhancement, study administration, ICH-GCP training, site monitoring, data management, statistical analysis, medical writing, and regulatory support to pharmaceutical, biotechnical, nutraceutical, nutrition, and device companies in the United States and Europe. VetPharm employs a comprehensive study management system and a consortium of study-ready investigators which facilitate rapid study initiation, accelerated enrollment, and superior results to meet sponsors' critical timelines.
VetPharm has broad clinical trial experience across all therapeutic areas which enables it to undertake virtually any trial and complete it quickly, efficiently, and accurately. VetPharm's investigator consortium includes board-certified specialists in the following disciplines: Behavior, Cardiology, Dentistry, Dermatology, Endocrinology, Gastroenterology, Immunology, Internal Medicine, Neurology, Oncology, Ophthalmology, Radiology, Surgery, Theriogenology, and Urology.
BioAgilytix is a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development. With laboratory locations in North Carolina’s Research Triangle Park; Cambridge, Massachusetts; San Diego, California and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of biologics across a number of industries and disease states.
BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (i.e., product release testing, stability testing, etc.) BioAgilytix also offers diagnostic testing services at its CLIA-certified, CAP-accredited Boston laboratory.
BioAgilytix’s team of highly experienced scientific and QA professionals ensures high-quality science, data integrity and regulatory compliance through all phases of clinical development. BioAgilytix is a trusted partner to many top global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.
Drug Discovery Alliances is a provider of chemistry and formulation services bringing together scientific expertise and support during all stages of the R&D continuum for emerging biotechs, existing multinationals and the United States government. We provide a global service where our partners – located in N. America, China, Japan, Czech Republic, England, Germany and Italy – cover four key services:
• Analytical Method Development
• Catalysis Screening
• Metabolites, Impurities ID & Synthesis
• Process Research
• Reference Standards
• Solid Form Capabilities
Manufacturing (Phase I-III)
• Advanced Intermediate Manufacturing
• API & Commercial Manufacturing
• cGMP Manufacturing
• Final Drug Product Manufacturing
• Formulation Development
• Quality and Regulatory Support
• Raw Material Manufacturing
Chemistry Technology Platforms
Aseptic Fill & Finish
• Heck Reactions
• HPAPI / High Potency
• High Pressure
• High Temperature
• High Throughput / High Resolution X-ray Diffraction
• Polymorph Screening
• Powder Filling
• X-ray Crystallography
• 4 year program for development of Regulatory Starting Material supporting NDA filing for a neurology product
• Urgent API consulting for Clinical Phase III with supplier change and identified savings of $10M
• CMC project consulting on pre-IND candidates ($760M) for a CNS product licensed by Astellas
• Generic new formulation consulting supporting Clinical Phase III for 505(b)(2) for hypertension product
• Commercial API manufacture for ophthalmology product sourcing key suppliers leading to successful FDA approval
• Phase III API for antibody conjugate for oncology identifying key supplier