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informatics for CROs


Chris Molloy, VP corporate development at IDBS


between CRO and customer, data management becomes one of the most critical issues. Te unique perspective that CROs have on the informatics space is that they are oſten working for multiple parties across their business. Tis leads to a number of different requirements including the maintaining of security between projects, adaptation to varying ontologies and data standards, and the financial incentives of reporting that data quickly and effectively. Te implementation of data management soſtware along with domain process modules allows CROs to become much more efficient, reducing the time to reportable data. Security provisions are also crucial in eliminating the potential for data cross contamination.


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THIS APROACH NEEDS AN INFORMATICS SYSTEM WITH SUFFICIENT GRANULAR SECURITY


Historically, communication of data has


been very document-centric. It has been the movement of PDFs or spreadsheets, or even PowerPoint files, but the passing of these structured or unstructured documents actually causes a break in the flow of information. Tis is because the lack of sufficient context reduces insight into the quality or provenance of the data. Te solution is to open up a data channel that provides the customer with secure, right-time access to the data that is captured with context. Tis enables customers to have faster results, to be able to look into their CROs’ processes and identify the stage their work is at, and question the data environment. In addition, it allows customers to better challenge scientifically the data being generated, building trust for all parties. Of course, this approach needs an informatics


system with sufficient granular security to make sure that any given customer can only see and query their own data. Single log-on systems are simply not able to support the complex multi- customer environments of CROs and they have suffered in the past from being asked to use multiple systems. Te movement towards multi- party solutions with granular security therefore provides improved efficiency on both sides.


8 SCIENTIFIC COMPUTING WORLD


s data is the product of the relationship


Efficiently and securely transferring data from our systems into the clients’ systems is made more difficult when the requirements of one client differ greatly to those of another. As a result, we have been looking at implementing more lean processes and trying to make them as efficient as possible internally, while maintaining that key point where we can diversify based on client needs. Rather than being in the situation where every single stage is bespoke to the client, such as having the project database set up in a very specific way, we’re trying to harmonise the structure so that it is only when we are exporting data that the differentiation comes in. Having that consistency of internal processes also means that, when our chemists or biologists move between different projects, they don’t need to spend time familiarising themselves with their new project’s working practices. In terms of introducing new informatics


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solutions, we are just about to go live with a project tracking and data management solution for use by project teams and our DMPK (Drug Metabolism and Pharmacokinetics) group from Te Edge Soſtware Consultancy. BioRails PTO allows our project teams to submit requests for assays and track their progress. It queues requests from multiple clients so they can be


Ian Berry, manager, informatics at Evotec


s a drug discovery solutions provider to the pharmaceutical industry, the biggest challenge by far is data exchange.


efficiently processed by the DMPK group. BioRails DM and Morphit provide all the data management and data analysis capabilities they need respectively. Morphit, a flexible Excel-like front end, allows


us to process and analyse the data working seamlessly with the data management system to store all the data in our database. It allows us to consolidate results and selectively provide


THE BIGGEST CHALLENGE BY FAR IS DATA EXCHANGE


them to the right clients in the required format. On our chemistry side, we use ChemAxon’s JChem suite of tools to provide cheminformatics functionality. Our ELN, iLabber from Accelrys, is deployed across all domains and the feedback we have from chemists is that it’s simple and allows them to record their experiments effectively, while our biologists like it because they can treat it just like a paper notebook. Te only difference is that it’s in an electronic format, which allows users to embed Excel files.


Thomas Rozlucki, MD of Contur, a wholly-owned subsidiary of Accelrys


I


n the past five years, the business model within


the pharmaceutical industry has


transitioned from a focus on internal resources, to where partners are being used to a far greater extent. In many cases, CROs are small organisations with limited budgets, but which face the same challenges as their larger counterparts, such as protection of their or their customers’ IP, the internal and external sharing of data, and the need to boost productivity. With regards to informatics, these are similar to the needs of any user, but what makes CROs unique is that need to cross organisational boundaries. Historically, there haven’t been any solutions


tailored to this that would enable everyone in this eco system to feel comfortable and


confident about security and data integrity. Tere is also the question of who should pay for these solutions. In some cases, the CRO will make the investment so that internal systems will store knowledge in a centralised fashion. Many don’t have that solid foundation, but if a CRO is serious about being a partner to pharma or biotech companies, they need to think carefully about data management and how to build that internal knowledge vault. Informatics platforms are a key part of this and CROs should work with vendors who can assess their needs and who truly understand the nature of these collaborations.


WHAT MAKES CROs UNIQUE IS THAT NEED TO CROSS ORGANISATIONAL BOUNDARIES


www.scientific-computing.com


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