The Drug Industry Association (www.diahome.org) has invited me to deliver the keynote address at its 18th annual electronic document management conference in Philly on Feb 16. I’m interested in opinions and insights regarding hot topics that keep content professionals in pharma awake at night.
Hot Topics for Life Sciences Industry
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I think one of the key issues with Pharma industry – in the drug discovery field is how to exchange content with the External Service Provider for their services. While the orgnisation is planning to structure the content in XML, the external world is not yet ready for XML. Hence there is technical bottleneck how to communicate the unstructured content to the rest of the world.
One of the key issues that pharma R&D facing is how to exchange the unstructured content with its vendors. While the organisation has XML based content, the outer world is yet to be ready for XML. Hence there is bottleneck when the structured world interacts with the unstructured world.
I would like to hear about the following topics if possible:
Standards: The Pharma industry is too diverse at the moment with companies of differnt sizes and different capacities for implementing technological solutions. However no company is big enough to impose their standards to the others. CDISC and HL7 are good starting points but much is yet to be done to standardize data and documents interchange.
Secure communication: Pharma is a huge producer of documentation and much of that is now electronic. Communication over the www is mostly non secure and poses a problem when proprietary information needs to be exchanged between lisence partners, merging companies, sponsors and investigators, investigators and IRBs, sponsors and regulatory agencies and so on.
Electronic archiving: producing electronic documentation calls for robust solutions for e-archiving. 21 CFR part 11 sets the rules but does not provide solutions. The industry is at risk of loosing valuable assets and is hesitant to implement e-signatures that would create original e-documents.