Services
Project Management Support and
Workplace Improvement
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Business process outsourcing and workplace
automation
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Enterprise
support in life science, insurance and
healthcare practice
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Web based
electronic documentation of clinical and
performance data
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Tactical and
strategic project Support and management of
project timelines
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Coordination
and integration of CRO support
Research and Development
- Preformulation and formulation
development
- Validation of analytical methods
- Manufacturing development and scale-up
concepts
- Stability assessment, statistical
analysis, and SAS programming of chemical data
- Ruggedness and robustness of formulation
and methods
- Data Management and control
- Antimicrobial preservative efficacy
- Characterization of particulates in
product
Medical Writing and Regulatory Document Management
- Preclinical Reports, Investigators'
Brochures, Integrated clinical and statistical reports
- Regulatory document management
- IND/NDA Preparation, statistical
analysis of integrated reports (safety and efficacy)
- Case Report Form Design and Production
- Investigators' Meeting Management
- Subject narratives for SAE reporting
- Annual reports and study updates
- Manuscripts publication management
Quality Assurance/Quality Control
- Site and document audits
- Vendor qualification
- Manufacturing and laboratory audits
- Data and Database audits
- CFR 21 GMPs for industry
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