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informatics for CROs

Rudy Potenzone, VP of product strategy, informatics, PerkinElmer

pharmaceutical W

industry, CROs have become a key piece of the drug development cycle. Virtually every company is now using CROs for core research work, from the more regimented synthesis of compounds to the executing of screens. Te driver has largely been to reduce costs, but it has also given pharma companies the opportunity to find unique skill sets.


Te provision for bringing in an internal

group is very difficult; it takes time. CROs therefore provide a level of flexibility to get the work done without being a drain on resources aſter the project ends. Te downside, however, is the host of issues that arise when bringing an external group into the mix of developing compounds – time-zone and communication issues, and the challenge of keeping the team activity at the most efficient level, to name a few.

ith the recent changes in the

Tis is where the ability to use common

data systems is a must. It’s important for the CRO to specify the types of experiments that are to be executed, whether there are agreed protocols, and then use informatics tools to gather that information and move it to the pharma company in a more complete fashion. Having the experimental record is important and informatics systems have a significant role. Tere will always be complications when you have people outside your corporate firewall and, in terms of both speed and capacity, the internet is not standardised around the world. Oſten, our customers are providing licensces directly to their CROs, ensuring the data collection and reporting is the same across their projects within our ELN framework, and each company may use different technical strategies to solve firewall access. But this does lead to the challenge of training.

Oſten companies will set up contracts with their CROs to provide the soſtware tools they wish them to use and ensure they are fully trained. Of course, this all comes down to the decision of how tightly the integration between CRO and pharma is to be. Te key point is to ensure that all the necessary tools are there and that there is a clear plan of how much of the context, such as experimental conditions, can be specified sufficiently when the results are transmitted.

Nick Townsend, director of life sciences at LabWare H

aving the right solution can enable CROs to respond quickly to the terms and conditions set out by new contracts,

and demonstrate that they are adaptable to changing requirements. Every lab wants a flexible system, but with CROs it’s the life blood and letting clients know that samples can be handled in a certain way or reports delivered in a specific format personalises the service and could mean the difference between winning a contract and not. Tis inevitably means adapting the LIMS or ELN to the individual requirements of the client. Tere are essentially three types of lab

informatics system. First are those that are designed for a specific application. Tey do what they do and nothing more; so-called non-configurable products. Ten there are systems where the soſtware is completely customised and while that leaves the customer with a solution that is unique to them, it does make it difficult to upgrade and support. In


the middle of these two are standard off-the-shelf LIMS that have the ability to add client-specific configuration in order to adapt to fluctuating needs without altering or compromising the core product. LabWare LIMS and ELN fall into this category. CROs can also benefit from a degree of CRM

(client relationship management) capability in the soſtware, especially as projects develop over time. Solutions like our LIMS can operate on a commercial level by assessing work, issuing quotes, and tracking all associated costs.



Stephen Gallagher, CEO of Dotmatics


ompared to any other lab environment,

CROs are strangely very similar, but very different at the same time – and those differences can be quite subtle. CROs are incredibly particular about what they spend money on, as more soſtware oſten means fewer bench scientists. Informatics tools need to provide a big efficiency boost in order to be worthwhile, and before even considering the external interaction with customers, CROs need to examine their internal data structures. A large pharmaceutical or biotech company

will have what I like to call Armadillo security – a very hard exterior, but a soſt centre that enables people, and data, to move about freely. With a CRO, the challenge is to make it easy enough for staff to jump between projects if necessary, but within very rigid security



parameters. Tis is compounded even more when CROs want to make that system available to their customers. In the past, CROs wanted to replicate the

operating procedures of biotech or pharma companies, but over the years that has become much more sophisticated and CROs now want to allow customers to dynamically search, collaborate and make requests. Tese are fairly simple ideas, but making them work well in a collaborative environment is difficult. Workflows are becoming more of a talking point as companies get away from file-based results and communication and move towards live data that can be interacted with. Te days of emailing PDFs of results are slowly coming to an end and there are various informatics solutions suited to this change (including ours). Tin-client applications, such as our web-

based ELN, provide rich, flexible tools, and with a lower cost. With our ELN, users simply open a browser, connect to a URL and access the data. Te integration of a query tool also emphasises that sharing of information and when clicking on a compound, users can see the generated data, regardless of where it originated. Tis is incredibly beneficial in collaborative environments.

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