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Clinical Trial Services Click here for more details
Full drug development plans
Protocol Development
Case Report Form Design and Production
Investigators' Meeting Management
Data Management
Clinical Research Associates
All are qualified with 10 years of relevant research experience
Investigator/Site Identification
Prestudy Site Visits
Study Site Initiation, ongoing Site Monitoring, Site Close Out Visits
Site Training and Support
Medical Writing
Preclinical Reports, Investigators' Brochures, Integrated clinical and statistical reports for IND and NDA submission
Integrated summaries (safety and efficacy)
Subject narratives for SAE reporting
Annual reports and study updates
Manuscripts and publication management, abstracts, meeting management
Quality Assurance/Quality Control
Document audits
Site Auditing
Manufacturing and laboratory audits
Database auditing
Data verification
Vendor qualification
Regulatory Services
Pre-IND and -NDA meetings
Regulatory document management
IND and NDA preparation
Annual reports
Expert Witness Services
Greystone has been providing expert service for the legal profession for over ten years. Being a group of MDs and Ph.D.s, we are able to provide expert service in a wide area of therapeutic disciplines including, but not limited to:
Pharmaceutical medicine:
dermatology, infectious disease, internal medicine, physical medicine, rehabilitation medicine, addiction medicine, obstetrics, anesthesia
FDA regulations and Regulatory Affairs
Drug development
Scientific Affairs
Clinical trials
Pharmaceutical labeling
Pharmaceutical manufacturing (drugs substance and product)
Clinical Pharmacokinetics
Toxicology and vet pathology
Synthetic Chemistry
Physical Chemistry
Organic Chemistry
Biochemistry
Medicinal Chemistry
Analytical Chemistry
Biostatistics
Quality Assurance
Industrial Pharmacy
Microbiology
- Quinolone antiinfectives
- Antifungal drugs
- Beta-lactam drugs (penicillins and cephalosporins)
- Immunology
Acetaminophen toxicity
NSIADs
Pharmaceutical marketing and marketing research
Pharmaceutical sales and sales management
Appearances in state and Federal Court involving matters dealing with pharmaceutical and biotechnology agents and microbiology issues
Microbiology Development Services
Including antimicrobial agents
Manufacturing development
Expert microbiology services
Statistical and Data Handling Services
Data base design
Double data entry
Electronic CRFs for data collection
SAS programing
Statistical analysis
Preparation of the statistical section of the integrated report and the NDA
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