Data management and software consultants Limelogic can help Life Science organisations keep track of important data throughout the clinical development and trial process. Exploring the relation between different sets of data and managing clusters of information form an interesting challenge that Limelogic gladly takes on.
Most Life Science development projects involve large pools of information that – if they are analyzed correctly – can become valuable knowledge banks. But the amount of information collected and related to a single drug development project can be large, in many different formats and difficult to handle without access to the right tools.
“The purpose of collecting data throughout the development process is foremost to support product development and create a basis for a future approval of a new drug. Thus, the data actually represents an investment, but without proper analysis the return on that investment may be far less than expected. This is why Limelogic exists; to assist in implementing the processes and tools for transforming data into valuable knowledge,” explains Magnus Mengelbier, Managing Director Limelogic AB in Malmö.
Clinical data analysis at its best
There are a variety of analysis tools available on the market. Limelogic implements all, or at least the major globally accepted software systems for management and analysis of clinical data. The commonly known systems are SAS, R, Spotfire, QlikView and SAS/JMP, but there are others based on similar principles.
“After working in environments provided by global software companies for a very long time, we have developed our own software system for effective management and analysis of the different types of data and formats related to clinical studies. The system, which we call Curo, is designed to avoid a large part of the manual work related to information management and analysis in clinical trials,” continues Magnus Mengelbier.
What makes Curo special is that it automatically tracks, manages and performs most of the data analysis which will in turn ease the decision making process in drug development projects. It is specifically suited to very complex developments and fields such as oncology or immunotherapy. Most importantly, Curo eliminates manual processes without compromising documentation requirements.
“I would say that Curo belongs with the next generation tools for data analysis in clinical applications. The present analysis tools, such as SAS and R, are ideally the engines or power sources behind the development of our product. Most important is to realise that not one tool does everything, so it is important to implement a good business process with the tools that give the greatest benefit,” says Magnus Mengelbier.
No need to reinvent the wheel
Even before Data Transparency entered the scene, it has been important for drug developers at all stages to keep track of their information flows – and especially how data is managed, analysed and shared. Large pharmaceutical companies may share their knowledge through Data Transparency initiatives in order to increase the benefits to society at large.
“Although the industry is generally characterised by secrecy and protection of Intellectual Property, it is possible to share information that may affect future drug development and opportunities to create better treatments without infringing intellectual rights. New frameworks for sharing, such as the European Medicines Agency policy published in October 2014, are evolving as we speak,” according to Magnus Mengelbier.
It is especially important for small development companies to gain access to information that already exists regarding a particular substance and its properties, how it reacts in different environments and what indications it gives during clinical trials.
Through the European Medicines Agency policy and Data Transparency initiatives, more research groups within the industry and academia will be able to take advantage of knowledge that already exists. There is no need to reinvent the wheel. The amount of information is increasing all the time, it becomes more sophisticated and above all the development requires more powerful systems to manage clinical data.
“Data analysis tools and software that are already available on the market can be connected to form a basis for really good decision making and this is how we contribute. With Curo we take yet another step towards providing a more automated and at the same time accurate analysis, which is required for future clinical applications,” says Magnus Mengelbier in conclusion.
