Gathering big data is just part of your business analytics solution. The rest of it involves understanding what to do with that data, and learning how to use it for your best business advantage. It’s about figuring out how technology can help you learn more about your business, learn how to make your business better, and then making it all happen. The integration of business analytics and innovation technology in a regulated industry provide specialized support in:   

• Quality Management Systems
• Regulatory Information Management Systems
• Process Improvement Methods
• Safety Systems Configuration and Analysis
• Pharmacovigilance Reporting Tools
• Data Mining and Signal Detection Methods
• Vendor Management
• Inspection Readiness Activities

People are the number one resource in every organization, so planning a company’s future means taking into account the needs and expectations of the people who make up the company. To gain an understanding of people at your company, we engage in a number of strategies to learn your company culture, and when we plan for the future, we keep the present in view. Our operations strategy in a matrix environment include optimum industry standards in:

• Drug Safety
• Risk Management
• Pharmacovigilance Training and Compliance
• Regulatory Submissions
• Quality Review of Safety Update Reports
• Aggregate Reports
• Quality Assurance Audits
• Regulatory Authorities Inspections
  

Closing a new project or contract is exciting, but it can also be overwhelming. With our project management services, you get the guidance, coaching and tools you need to handle new challenges with skill and dexterity. First, we'll establish the needs of the new project and take into account the scope of how your internal resources can meet and surpass the demands of the project. Project management support services delivers in areas such as:  

• Risk Management Plans (RMPs)
• Risk Evaluation and Mitigation Strategy (REMS)
• Medical Writing and Management of Aggregate Safety Reports (ASRs)
• Pharmacovigilance Standards Training and Compliance
• Regulatory Submissions
• Quality Review of Safety Update Reports
• Standard Operating Procedures (SOPs), Work Instruction (WI) Templates and Job Aids (JAs)
• Corrective Action/Preventive Action (CAPA) Response Letters