In managing Chemistry, Manufacturing and Controls documents, the larger process is involved for electronic regulatory submissions to health authorities. This is a case of an entire process standard providing significant gains in efficiency. A solution is needed for this area of the biopharmaceutical industry.
Data mining has always been important to our industry. Having the ability to mine across the entire product lifecycle has always been the goal. To date, data and systems' 'non-interoperability' has been one of the major challenges to this effort. This case study will describe how data mining capability was enabled initially by Clinical IT.
IT can play a key role in cutting down the costs of production and helping biopharmaceutical companies maintain regulatory compliance.
The pharmaceutical industry is facing increasingly severe challenges to its mission of delivering novel therapeutic solutions for unmet medical needs. Today, a heightened focus is being placed on leveraging maximum value from its core asset-information.
Consolidating and integrating data across systems and relationships can help manage some of the challenges associated with supplying investigational and comparator drugs for clinical trials.
Business intelligence solutions, proven in other industries, offer the troubled pharmaceutical industry the potential to enable both operational excellence and better technical management to support drug development for the future.
The adoption of simple and easy-to-use Web 2.0-inspired technologies and approaches inside the enterprise provides companies with opportunities to improve their collaboration, communication and knowledge sharing.
Outsourcing pharma or biotech research IT can be very difficult to implement but with a well-planned strategy the benefits can easily outweigh the risks.
Service oriented architecture promises to revolutionise the way companies share information internally, as well as with partners, customers and regulators.
IT governance defines a structure of relationships, processes and measures to direct and control IT in order to achieve the enterprise's goals.
By using knowledge tools to better understand a potential new drug’s effectiveness and safety early in the development process, it becomes possible to terminate potentially problematic drugs earlier, saving both time and money.
IT breaches lead to identity theft, counterfeit drugs, low productivity and revenue loss.
The IT spending of companies reflects their strategies to introduce new drugs, enter new markets, and be more competitive in the challenging Asian pharmaceutical market.
Digital Pharma will enable lifesciences organisations to improve operations and decision making across the entire industry value chain.