LABORATORY INFORMATICS


“CDISC has generated a suite of standards categories, underpinned by a set of core foundational standards”


is that companies are outsourcing the data formatting as a service, so every time they need to do a submission, they have to engage a vendor to prepare the submission for them. The cheaper alternative is to do it themselves, but without the right tools this is a highly manual and inefficient task, and so they’ll approach us to ask if we can help them to do it all the more quickly?’


Making sense of drug development data Certara specialises in offering software and services that span the drug development lifecycle – from discovery to patient access. The company’s expertise, modelling and simulation, and regulatory- focused software are designed to speed the development timeline, and accelerate regulatory approval. Certara has expertise in the pharmacokinetic field, and in the development of software tools and services for the generation and management of PK data. Certara is a platinum member of CDISC,


has a seat on the CDISC Advisory Council, and has a certified CDISC trainer on staff. It is also involved in the creation of the ADaM NCA standard. ‘We have also been contracted by several big pharma companies to create custom software solutions for Send and SDTM, including ADaM datasets,’ notes Trimm. It was a natural step for Certara to


become directly involved in the CDISC community, Trimm said. ‘As a software company involved in the analysis of data that forms a key part of regulatory drug submissions, Certara realised the importance of becoming involved with CDISC. ‘A large component of what we do as a


commercial organisation is manipulating data management, and having standards is actually beneficial for us and ultimately for our customers. We provide off-the- shelf, and tailored software, that enable companies to create the domains that will work with the CDISC standards. As a platinum CDISC member we have input into key decisions that are made during the development of new standards.’ ‘We have some products, which you


can buy commercially off the shelf, that will create those domains for you, but we are primarily engaged in building custom


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software solutions for companies, so that we can address their particular needs around their data sources and native formats.’ Part of the problem for companies that need to think about and implement electronic submissions, is that often the people who are producing the data – the scientists – are not the people who understand standard format data submissions and CDISC. ‘What Certara tries to do is to represent, through our software, a kind of data standards expert, so the user can interact with the software to manage the data, rather than having to send the data to another department to be managed. ‘Providing the CDISC knowledge and


ability, within and through an application that is easy for the user to interact with, not only removes the need to send data back and forth to a data specialist, but also gives the scientist who is generating the data a basic understanding of why they need to structure their data in particular ways.’ There are issues when considering the standardisation of analytical data, according to Andrew Anderson, VP business development at ACD/Labs. ‘The different analytical techniques used to help assess the identity, quality, and purity of substances, compounded by the plethora of instrument vendors with proprietary data formats, makes standardisation of analytical data a unique challenge.’ Add to this instrument innovations that allow scientists to delve deeper and collect more data in shorter periods of time, Anderson noted, and that adds another dimension to a ‘moving goal- post’. He noted that there two ‘major


challenges’. One is that ‘scientists are relying on data transcription between systems to bring relevant data together for decision making, which introduces the risk of errors – something to be avoided, especially with the growing emphasis on data integrity and the ALCO principles for data, that it should be attributable, legible, contemporaneous, original and accurate’. The other challenge is that scientists are ‘relying on abstracted data, effectively complex spectral and chromatographic data simplified to images, numbers, and text, without chemical context and meta- data.’


While many attempts have been


made to standardise analytical data over the years, no single accepted standard has been universally adopted by instrumentation vendors or their customers, Anderson continued. ‘There have been notable analytical data standardisation efforts, and since 198 these have included the Galactic *.SPC format; *.CDF from Unidatata NetCDF, IUPAC *.JCAMP-DX, *.mzXML, and *.esp and *.spectrus from ACD/ Labs. More recent emerging standards include *.AnIML and *.ADF from Allotrope Foundation.’ ACD/Labs claims to offer ‘the only commercially available standard that allows for homogenisation of all major analytical techniques from the broadest number of instrument vendor formats,’ states Anderson. ACD/Labs recognised that many


different analytical techniques are necessary to characterise substances and make decisions around identity and composition, and that this information is often required by regulatory authorities before substances can be approved for use, Anderson said.


December 2019/January 2020 Scientific Computing World 15


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