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15 June 2011| Article by Henrik Nakskov
June 2011 | Article by Principal Consultant Henrik Nakskov, NNIT
The more we know the better?What is the raison d’être for pharmaceutical companies? An ethical one would be that pharmaceutical companies must develop innovative products that make a difference for people. An improvement at even the smallest margins potentially translates into prolonged life or improved quality of life. So we measure at more and more delicate margins – hoping to discover the one magical compound in the alchemist’s kitchen that has the potential to make a difference – and to become a blockbuster. Because, let’s be honest: regardless of the noble work we are not in philanthropy. It’s also tough business. Every day preceding the launch of a new drug is an investment. Eventually shareholders crave value for money.
Generating potentials is part of the purpose of aggregating data. So offhand you should think “The more we know the better” – however, the growth of data is paradoxically becoming an obstacle rather than an automatic competitive factor. And it is not only the scientific data per se; it is also the metadata, the documents and reports to e.g. regulatory authorities that are in escalating growth. It seems to be a development driven by an unbending algorithm. To get on top of data and turn it into an advantage a new approach characterised by system integration and cross function integration is required. The answer lies in digitalisation of the information chain. In short: Go digital or die!
Value is in the data processing Companies must adjust to the fact that value is not generated in the production capabilities, but rather in the data processing abilities. This means that data must be mastered and handled in various levels and activities such as:
• Clinical Trial Management• Internal data sharing• Documentation to authorities• Data Management • Protocol planning• Product strategy development• Meta Data Management• Finances
It is obvious that this is more easily achieved when digitalised. And if you haven’t already initiated the transition from paper based to digital, now is the time: Kiss paper goodbye and embrace IT.
From paper to digitalThe development of CFR-Parts in Clinical drug development illustrates the impending necessity of the transition: 5-10 years ago a CFR-Part typically comprised of 30 pages – soon it will amount to 300 pages and will gradually become more and more prohibitive. The company still relying on paper will suffer from a self-inflicted handicap that progressively will manifest itself and hold back the company.
But there isn’t a “silver bullet” IT system that will do the trick. For a successful transition from paper based to digital you have to perform an eClinical analysis – a stepping stone to get the digitalised data flow right. In this context IT is simply a facilitator, a necessary means of transportation for data. But in order to transport data to the right places and make it available to the right people at the right time, processes and structures have to be analysed and optimised according to the information supply chain. In a broader perspective eClinical is all about an enablement of an IT implementation of the business visions allowing data to be transformed into true business assets.
The individual company processes must be aligned with knowledge management based upon dataflow optimisation. Proper governance structures have to be established as well. To ensure the stability of the eClinical implementation a structured approach is recommended:
• Analyse and define future information management structure (eClinical)• Establish data standards as the foundation for the entire drug development IT architecture and build the foundation for Master Data Management. • Implement the solution (Organisational Change Management)• Stabilise (Data Governances structures)
Without the proper alignment between the various steps there is a risk of jeopardising the final outcome of any eClinical solution.
Structure turns data into actionable information The outcome of the eClinical analysis that NNIT performs is an optimisation of the interdependencies in the hierarchic chain of information management. You can maximise your benefit from data, once you induce structure and order according to the logical data supply chain:
1. Data Management2. Clinical Trial management3. CDW + records management4. Pharmacovigilance5. Regulatory Management6. Regulated Document Management7. eSubmission (CDISC)
The goal is to turn data into actionable information. With an optimised information flow based on the outcome of your eClinical analysis along with fully digitalised and integrated processes you are ready to capitalise on your data assets. This will allow you not only to stay in business but also to earn a competitive head start.
Ensure commitment to changeIn an upcoming article we will treat digitalisation and IT driven changes from an organisational perspective. People and processes are deeply entangled – and at the end of the day people commitment is the ultimate criteria of success. So stay posted till the next article and read how to successfully implement IT changes and ensure that the people working with the affected processes fully accept and benefit from a new way of doing things.
If you would like to know more about how to maximise the value of your data assets please contact Sales Executive Andreas Birch on +41 79 215 27 79 or email@example.com.