Akasa Global
Professional Services For Life Sciences
Services
Program Management
We bring a strong services background with focus on implementation and upgrade of drug safety and regulatory solutions, particularly ArisGlobal’s ARISgTM and RegisterTM suites.
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As part of Program Management we provide following services
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Scope Management
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Time Management
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Budget Management
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Resource Management
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Issue and Risk Management
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Quality Management
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Integration Management
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Data Migration Management
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Communication Management
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Validation Management
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End to End Implementation Management
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* We can represent sponsor's program / project management in system-vendor or third-party implementation teams.
Safety Solution Landscape design
With a combined experience of 50+ years in providing Drug Safety Solutions and Services, we are intricately familiar with all aspects of drug safety solution components. Extensive experience in both designing and deploying health sciences cloud applications
Advisory
With over 50 years’ combined experience developing and deploying safety and regulatory systems, our team can expert advisory services in the areas of:
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Business requirements definition
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Safety system assessment and selection
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Designing or improving safety processing workflow
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Compliance management
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High-performing architecture
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Process and system integration with complementary enterprise applications
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Vendor management
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Multiple industry leading web-based, off the shelf software solutions are available for
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Pharmaczovigilance which provides a comprehensive capabilities in the areas of case receipt, case processing, dictionary coding, electronic submission and regulatory reporting.
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Regulatory information which provides capabilities in the areas of registration tracking and updates, variation tracking, questions and commitments management, submission tracking (XEVMPD, IDMP).
Akasa provides unbiased program and solution end to end implementation view for the pharmaceutical/sponsor thus providing expected value and return on investment.
The Akasa team has a particular focus and expertise around market-leading, ArisGlobal’s ARISgTM and Regulatory TM Suites​
Validation
We can provide the full range of validation services:
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Validation plan
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Documentation
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Acceptance test plan and testing
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IQ, OQ, PQ
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Assessment of validated Cloud deployment