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Small pharma, big requirements

neil saward and bob merrill | bioscience technology | 25 april 2016

Regardless of size, biopharmaceutical companies need to ensure that the products they are developing are safe. To achieve this, they need to be able to demonstrate careful control of the data, which is created from research, clinical testing, and clinical trials, as well as from judiciously following guidelines laid out by the Food and Drug Administration (FDA) that are in place to protect patients.

However, for a small or medium BioPharma companies, the cost of buying and supporting many of the scientific and clinical systems, analysis tools and data management technologies can be prohibitive. How can smaller BioPharma companies implement appropriate controls without huge infrastructure and costs?

Most BioPharma companies are probably already outsourcing some aspects of their clinical trials to Contract Research Organisations and, given the increasing availability of robust, virtual IT, organisations can now use cloud-based technologies for much of their technology needs. This can substantially reduce upfront costs, effectively secure data, and enable access to computing power and capabilities that are typically unavailable to smaller companies. Indeed, it is conceivable and highly likely that in the near future, BioPharmas will have no IT systems or infrastructure in-house.

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To ensure that they are benefiting from these technologies, there are a number of aspects that organisations need to keep in mind:

1. Structure agreements to accommodate growth – one of the key benefits of cloud technology is that you can scale capacity based on what you need or use. For smaller organisations, this can really help with flexibility and minimizes the need to buy expensive equipment that may never be used. Cloud agreements can be structured with capacity scaling as rapidly as desired while their business grows, with ‘pay as you go’ pricing. Organisations should beware of those suppliers packaging fixed, dedicated infrastructure with long-term agreements; often these arrangements are marketed as ‘cloud’ but are nothing more than hardware purchases packaged with co-location data center services, and will not afford the flexibility and economies of scale that true cloud solutions offer.

2. The cloud can be secure – data security and privacy are of paramount importance to BioPharma companies. Most major cloud hosting providers offer cloud computing infrastructure with security that surpasses those available to BioPharmas that are looking to implement their own computing infrastructure on a limited budget. However, it is important that supplier claims about protection of data are carried through to cloud services contracts, establishing clear responsibility for protection of data and appropriate liability provisions for data breaches.

3. Moving IT outside of the organisation may change the blend of IT skills required – when buying cloud or ‘Software as a Service’ solutions from a vendor, requirements to support infrastructure and technologies in-house will be incrementally reduced. However, there is frequently a shortage of the supplier management skills to establish appropriate contracts and associated service levels, and to manage the suppliers to deliver the services in accordance with the service levels.

4. Plan how the IT solutions will fit together – you would never dream of building a house without an architecture drawing and the same is true for designing your IT. It is a critical and often overlooked component but having a clear plan which helps you understand which solutions need to talk to each other, where data will reside, how solutions will communicate, which business and IT functions have solutions, and where gaps exist. This minimizes the risk of missing key components and ensures that your overall IT will meet your organisation’s needs.

Organisations can access a wide range of capabilities in the cloud. This can help lower infrastructure and support costs, improve robustness and provide organizations with greater flexibility. One recent example of how this has worked for BioPharmas include a medium-sized BioPharma organisation that wanted to transform its IT function to bring down costs. Once they adopted cloud technologies into their infrastructure, they were able to reduce costs by 50 percent. Another recent example is a Pharmaceutical organisation that was looking to improve Clinical Document Management capabilities and improve the robustness of a number of core finance solutions. With the help of PA Consulting, this company was able to improve the stability of their core business solutions by over 80 percent.

Neil Saward and Bob Merrill are life sciences experts at PA Consulting Group 


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