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With competitive pressures and strict regulation, companies operating in the pharmaceutical industry need to be able to analyse and streamline core business processes and deliver corporate and regulatory governance to the highest standards.
Currently, pharmaceutical organisations are failing to adopt efficient processes, as well as communication and reporting tools, despite being known as the “innovation sector”.
It is in the area of compliance that the pharmaceutical industry faces its biggest challenges. They need to comply with regulatory bodies such as the FDA, HIPAA and the UK Data Protection Act. This is where Business Process Management (BPM) can be so valuable.
Regulatory compliance is expensive! It is estimated that 35 per cent of the total cost of a clinical trial is spent on meeting the strict regulations laid out by the likes of the FDA and HIPAA. It is this pressure to meet standards that causes the cost of clinical trials to far exceed set budgets.
These factors mean that pharmaceutical companies must look at their business processes and try and discover efficiencies which will mean that drugs are quicker to market, thus reducing costs.
A successful Business Process Management implementation can introduce an organization-wide central repository or “single source of truth” that would remove the causes of non-compliance, as well as uncover value-generating opportunities.
All employees would have a line of sight with regards to compliance by using a process map to show accountability and to identify where there are still gaps in knowledge.
There is an opportunity for Business Process Management to significantly impact the pharmaceutical industry through the adoption of a flexible modelling solution which can be individually tailored to each organisation.
Business Process Management should be one of the top priorities for compliance groups and process management professionals. In a world where the fines for non-compliance can make or break an organisation, the pressure of these professionals has never been greater.