Life Sciences Concentrations
New Product Development
Get better therapies to market faster.
For every drug and medical device that generates billions of dollars in annual revenue, scores of other potential new products fall by the wayside after incurring significant R&D expense. In addition, increased pricing pressures from managed care organizations, government agencies and other health care payers further squeeze industry profit margins. As a result, life sciences companies are under increasing pressure to get better new products to market faster in order to recoup staggering development costs, produce a profit for investors and improve public health.
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CBOS’ Performance Management and Analytics can help increase performance in New Product Development in the areas of:
- Business Development \ Licensing of technology
- Research and Development
- Clinical trials \ CROs
- Clinical manufacturing
- Regulatory Submissions
- Scale Up \ Technology Transfer
- Project Management
Improve effectiveness Reduce inefficiency.
Operating in a highly regulated market with increasing competition allows no room for error. Research & Development (R&D) costs are spiraling, development timelines are growing, payer pushback is increasing and consumers are becoming increasingly knowledgeable about care options. Life sciences companies are under increasing pressure to improve the effectiveness and cost efficiency of their supply chains while simultaneously ensuring the continuous availability of medications when and where they are needed to treat patients. The supply chain of the future will be built around flexibility, responsiveness and reliability shifting the supply paradigm from a stock-based model to an order-based model.
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CBOS’ Performance Management and Analytics can help increase performance in Product Supply Chain in the areas of:
- cGMP Manufacturing \ Contract Manufacturing
- Procurement
- Vendor Management
- Training and Standard Operating Procedures
- Batch Records
- Packaging and Logistics
Quality, Regulatory and Pharmacovigilance
Align Processes with regulatory requirements.
Regulatory agencies expect Life Sciences companies to take a comprehensive and proactive approach to assuring the safety of patients.
Life Sciences companies must align organizational processes within regulatory requirements, incentivize the detection and escalation of risks, open and leverage new channels of collaboration, remove traditional barriers between the safety and clinical trials 'silos', and ensure 'C' level ownership of safety issues throughout the organization.
To meet increasing demands for the proactive management of safety issues CBOS’ Performance Management and Analytics help evaluate and predict safety events and maintain regulatory compliance.
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CBOS’ Performance Management and Analytics can help increase performance in Quality, Regulatory and Pharmacovigilance the areas of:
- Outsourced vendors
- EMA, FDA regulatory requirements
- Adverse event and signal data
- Standards, best practices, case studies
- Employable tools such as sample documents, check lists, standard operating procedures
- IT methodologies and specific best IT practices that support good IT governance and compliance for an IT department of in life science or healthcare environment.
