Make your new Smart Lab really deliver: Externalization

Business teamwork conceptIn my last blog, I mentioned that our customers are cutting R&D costs by outsourcing more and more routine lab work to contract research organizations (CROs).  This is nothing new – it‘s been going on for years, but the trend seems to be accelerating.  If all your measurements and analyses are currently in-house, you are behind the curve.  Already more than 30% of bio pharma R&D spending is going outside company boundaries, and this is only going to increase.  We have also seen the same customers partnering with academic institutions to access new sources of innovation.  Some companies have gone so far down this path that they have set up ‘virtual’ research groups: a small core of in-house staff run the project portfolio for an entire disease area, co-ordinating a complex network of CROs and other partners.

This approach might solve some problems, but it introduces new ones, such as: how do you handle results coming in from someone outside your organisation?  How much access to your corporate systems do you allow partners?

To make it easier to work with external collaborators and CROs, companies are looking at opening up their internal systems to the wider world.  We have seen different approaches ranging from allowing outsiders direct VPN access to an internal application (an ELN), to the creation of a cloud-based solution outside the corporate firewall to serve both in-house staff and outside partners.  Besides the technical challenges, there are many other aspects to think about, such as information security, ownership of IP, and relationships between different suppliers.

In general, I would recommend that any new lab systems are future-proofed by being designed to facilitate the transfer of materials and results across organizational boundaries.  For sample handling, you will likely need to provide collaborators access to your sample ids and critical context, while protecting your sensitive information from outsiders and viruses.  Try to use standard barcoding schemes so that third parties can easily read your sample data.  Make sure that results systems can accept direct external inputs or, at least, industry-standard formats.

One of our pharma customers has started moving towards a CRO-based business model, and is taking the first steps on the externalization journey.  A few years ago, we developed a platform for them to monitor clinical trials in real-time, reporting drug safety, efficacy and providing analytics on trial operations.  This system is the first to be externalized as part of their business change.

Rather than opting for a point solution for the externalization of this system, the client saw this as an opportunity to try out a common approach that could be applied across the board.  The sensitivity and confidentiality of the clinical trial data meant that the system posed many of the tough requirements and design questions inherent to externalization, providing a strong basis for a common approach.

Gathering the requirements and developing the architectural design required solid knowledge of the clinical trials platform.  Having developed the system in the first place, our team was well placed to understand how the CRO would use the client’s internal applications, and the security implications of handling sensitive clinical trial data and following tough security standards.  The technical problem of authenticating users outside the company firewall was solved by using third party providers for external identity management and single sign-on.  But we found the most challenging part of this project was getting all of the disparate IT groups in the client to work together: achieving this stretched the organizational and communication skills of our team!

In this blog, I have discussed one more piece of the Smart Lab puzzle.  In my next, the last of the blogs drawn from Tessella’s recent white paper Five Factors of Smart Laboratory Success, I will look at understanding the big picture – how all the pieces in your own organisational jigsaw fit together, and how to make sure that any changes you make will fit in with existing systems and processes, as well as meeting wider business needs.


Simon is a business analyst and consultant with more than 10 years experience in pharmaceutical ...

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