Due to the growing complexity of the drug discovery and development process, clinical trial disclosure, and global submissions requirements, the need for regulatory compliance and the management of information within a Life Sciences or Biomedical organisation is more challenging than in most industries.
Legal and regulatory requirements necessitate an active Information Governance approach for information assets often spread across geographies, jurisdictions, repositories and physical warehouses.
While regulatory compliance is vital, there are a number of other challenges and business opportunities that can only be full addressed through effective Information Governance. These include:
The volume of data generated by all aspects of Life Sciences was estimated as 150 exabytes – or 150 million terabytes – in 2011 alone. It is growing at around 1.2 to 2.4 exabytes a year. This amount of information is truly mind-blowing but within this data may be the cure for many of today’s most life threatening conditions.
It has to be captured, managed, stored, searched, transferred, analysed and visualised to identify the information that will be of most benefits. As importantly, with so much data, there has to be a comprehensive strategy for retention management and defensible disposal.
One area of Life Sciences that can benefit from Big Data disciplines is within the field of personalised medicine. By being able to anaylse vast amounts of information from different data sets, researchers can make more informed decisions on areas such as which patient will benefit most from a drug and which are more likely to suffer side effects.
This requires the integration, storing and classification of information from a large number of structured and unstructured data sources. An over-arching Information Governance programme is required to proper manage the processes and technologies required to make this a reality.
Compliance forms the basis for future standards-based collaboration by setting in place how information is stored and shared. Collaboration across Life Sciences organisations, researchers, technology providers and regulatory agencies is essential to develop the standards, technologies and solutions required to critically evaluate data and generate valuable information to improve the health outcomes of patients. More than most industries, an ‘Active Compliance’ approach will provide the organisation with an industry-established best practice foundation to efficiently and securely identify and share information.
Outsourcing and Supplier Relationships
All Life Science companies must reduce time-to-market, increase operational efficiency and increase financial returns. This has led to an increasing trend to outsource non-core business functions with the growth of Contract Research Organisations, Contract Manufacturing Organisations and Contract Sales Organisations.
The reliance on external organisations for these functions requires a new, multi-tiered approach to information management. Information Governance is essential to ensure that these third parties are mitigating the risk of non-compliance for information the organisation is responsible for. The Information Governance policies and procedures have to be adopted and applied across the entire supply chain and built into supplier contracts.