Research and Development |
Poor product pipelines, rising costs, new competition, impending patent expirations, and increased regulatory scrutiny are the dominant business issues facing research and development organizations. It is estimated that the clinical trial segment of the drug development process can account for more than 50% of the total costs associated with bringing a drug to market (estimated between $800 million and $1 billion per drug). Reducing the clinical development costs without introducing GCP compliance risk is a major area of focus throughout the life science industry.
At the same time, new regulatory guidance governing the structure and format of new product marketing applications – the Common Technical Document (CTD) introduces additional challenges for regulatory affairs organizations. Many companies are designing new processes, implementing new technologies, and developing new expertise to support CTD and eCTD implementations. These initiatives are often undertaken without interruptions to existing operations which must be kept running smoothly
How Patni Can Help
Reducing the time to obtain marketing approval for a drug from the FDA is a key to protecting the patent exclusivity for the product. Patni helps our clients optimize the drug development lifecycle through business process improvement and the implementation and validation of key technologies to improve operational efficiency.
The desire to decrease the time and cost associated with clinical trials will require the adoption of innovative IT solutions by the industry. In order to most effectively leverage these new technologies, companies must also re-engineer, implement, and provide education on enhanced clinical trials processes. Patni’s experience in evaluating, developing, and harmonizing standard operating procedures helps our clients as they embark on business transformation initiatives.
The costs associated with product withdrawals in terms of lost revenue and poor public image is a major source of concern for pharmaceutical companies. Building quality into the information management systems that capture, store, audit, and report the data that supports a companies claims of product safety and efficacy reduces that risk significantly. Ensuring that this critical information meets the regulatory guidelines set forth by the global health authorities reduces the probability of data-related issues and accelerates regulatory review and approval processes. Patni’s risk-based approach to computer system validation allows our clients to focus their efforts on those areas and activities where the greatest value will be realized.
Patni Services for Research and Development |
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