Data Management a Pain for Life Sciences
Data management ranks as the most important IT practice in healthcare organizations, and is also the source of the most difficulty, according to a recent industry survey.
Conducted by the Life Sciences Information Technology (LSIT) Global Institute (www.lsit.org), the survey examined the views of life and health sciences professionals who were engaged in information technology. Respondents spanned the globe, with 57% from the Americas, 22% from Europe and 14% from Asia Pacific. The 33% executive managers and 67% directors and other professionals represented the perspectives of life sciences (42%), IT (24%), R&D (18%) and healthcare (7%).
From a list of the most common IT practices in an organization, survey respondents were asked to rank the most important areas in need of attention in their organization. Of 11 possible choices, four clearly were top of mind to an astounding 94% of managers: data management, IT security, testing and validation, and IT infrastructure operations.
Data management ranked as the most important IT practice, and the largest percentage of survey respondents saw data management as causing the most difficulties in their organization.
Data is becoming more and more abundant in life science organizations, as analysis and testing grow for research and drug discovery processes. Policies and best practices are needed for good data management. Scientists that develop data must be able to store, reference, and age out data. Strategies are needed to identify a life for a document and data by which to move it off to other media.
And like their colleagues in many industries, life science companies must address government requirements such as Sarbanes-Oxley and HIPAA, as well as those from the FDA, in their efforts to preserve information over a period of time. Compliance activities are extremely important to ensure the integrity of data throughout the drug development process. Life science companies see their data as intellectual capital, and each individual bit of data must retain its integrity on every piece of storage hardware in the infrastructure.
Anette Asher, Executive Director of the LSIT Global Institute, sees the kind of information revealed in the survey as a valuable tool to "understand how current and emerging operations in areas such as data management and infrastructure deployment might impact the core deliverables medical therapeutics and products of these life sciences companies."
According to Asher, life science and health companies "face problems in cost-effectively implementing new information technologies, and just as importantly, in validating these new systems to benchmarks that are constantly changing and subject to regulatory control."
Good Informatics Practices Coming
In the survey, 83% of respondents felt they could significantly improve their data management and infrastructure operations practices. To meet this need, LSIT has launched an effort to collect the knowledge of the leading life science and health companies and system and storage manufacturers and use it to develop open, publicly available "trusted" IT guidance.
Known as "good informatics practices" (GIP), this guidance is designed specifically for the life and health sciences community to deploy and maintain effective operations across a range of IT practices that cover interoperability of data, images and information, and the privacy of it all.
LSIT activities will focus on data management and infrastructure operations of the medical research and the industrial life sciences sectors (pharmaceuticals, biologics, medical devices and diagnostics), and eventually healthcare provider and payor systems. Integral to the success of this effort will be the working partnerships LSIT founding members Pfizer, Novartis, Sun Microsystems and Amylin Pharmaceuticals are forging with the IT and life sciences industry, medical and scientific researchers, standards and government regulators and healthcare providers.
With the changing nature of the life sciences industry, individual company solutions are not alleviating inefficiencies, and mergers and acquisitions only exacerbate the problem of aligning separate IT processes without uniform global guidelines. Respondents said that improving their practices, and developing a common repository of system and storage methodologies, would benefit not only their individual companies but also contribute to consistent IT practices between and among life and health science companies and significantly accelerate the regulatory approval process.
"Answers to the survey questions both helped us define the environment and develop programs to assist our member companies in meeting the challenges of 21st century business operations," said Asher.
The LSIT Global Institute envisions that GIP guidelines for data management, infrastructure, and other IT processes will provide as significant a benefit as other important good practices in place today such as the Good Clinical Practices (GCP), the worldwide guidance developed by the International Conference on Harmonisation (ICH) for the conduct of regulated clinical research.