- Have you assembled the appropriate project team to implement a life sciences application?
The nature of projects and outsourcing today is composed of complex global projects managed by virtual teams and project variance. Outsourcing strategies and project variance leads to cost variation within a budget which usually is unaccounted for. Projects involving the implementation of life sciences applications can fail for multiple reasons – however a lack of user requirements and budget mismanagement should not be any of those reasons.
A good implementation team is usually a multidisciplinary team that adopts a risk-based approach to identifying obstacles and establishing measures that will mitigate challenges and foresee the participation of the client’s key users from the first steps of system implementation. The key users usually collaborate with the validation team in the definition of general/regulatory user requirements, but their involvement starts at the very beginning of the project. In order to include the key/business users at this stage, the IT Project Manager should include a Business Analyst in the project team.
By using this approach, key users can deepen their understanding of how the system works and if it fits their organizational structure, processes and procedures. Consider a multidisciplinary team of business analysts, project managers qualified and specific to the system being implemented and a Computer System Validation expert (see why below!).
- Are you leveraging cloud-based solutions for important clinical systems?
We have stated the data before: It has been estimated that cloud computing techniques could lead to a 30 percent increase in speed to trial for clinical work, resulting in up to $400 million USD in savings.
The benefits of implementing a cloud-based solution for electronic data capture are endless: no more IT infrastructure investments, better data quality and global study management, software reusability and more secure data transfers. More importantly, cloud-based systems allow access to real time data which supports better discrepancy management, faster data cleaning and ad hoc reporting.
Cloud-based SaaS systems are ideal and cost-effective for pharmacovigilance as well by implementing a system accessible through the Internet with minimal IT effort. In this scenario, the application can be deployed using the standard validation configuration and then be customized to meet customer needs. The Cloud eliminates the need for hardware and software installation and allows clinical applications to be accessed through a web browser with personal credentials, eliminating the need for IT infrastructure such as data centers.
- What clinical data visualization solutions so you have in place?
Is your company looking to have access to clinical data in real time? Is Risk Based Monitoring part of your upcoming clinical trial strategy? Data Visualization tools make it possible to collect clinical and safety data from multiple sources and display the data in a structured format for the study team. The analysis team has the ability to drill-down data and click-through multiple levels of details.
Perhaps the biggest benefit is the ability to see and analyze safety data metrics from multiple sources in real-time. Real-time alerting features can notify the study team when problems arise, for example when adverse events are entered. Real-time data results allow decision-makers to identify and fix underperforming sites and make crucial decisions.
Business Intelligence tools are the best technology option for Risk-Based Monitoring. They allow for data retrieval, report development from different data sources, report delivery and cloud-based technology. Web-based applications can be accessed from various devices including PC/laptops, smartphones and tablets.
- Are all of your systems up-to-date and in compliance with industry standards? Are they really?
As mentioned above, every successful life sciences project team should have a Computer System Validation and Risk Management expert. Computer system validation in the pharmaceutical industry is applied from discovery through to manufacturing and supply. Between 40-60% of software defects can be traced back to errors made during the requirements stage. The costs of IT quality can be an investment: from documented planning and prototyping to review and inspection and test execution. However, the costs associated with poor quality normally outweigh the costs associated with good quality.
Defect correction, including diagnosis and bug fixing, can produce enormous costs for companies. More importantly, external failure can cause huge losses for a company. Operational defects can lead to lost productivity and lost sales. On a more serious note, it can lead to a delay in a new drug approval or even regulatory fines.
Are all of your clinical systems up to date with the latest security patches? Discontinued software versions should be considered a high security risk for critical IT components and should be mitigated by upgrading to supported versions or migrating to newer solutions in other platforms.
- Is your company prepared for Disaster Recovery and Business Continuity?
In an increasingly technology-dependent world, is your company prepared for a power failure? Cyber attacks? Disaster Recovery and Business Continuity is crucial for life sciences companies today. Sponsors should know if their IT provider has a plan in place – after all, consider the quantifiable losses if your IT infrastructure shut down for an hour, a day or even more? Could you go on conducting “business as usual”=
A good Disaster Recovery plan starts with analyzing the risks. Once you have determined the priorities, the most important analyses will be the RPO (Recovery Point Objectives) and the RTO (Recovery Time Objectives). The RPO will establish how far back services will have to go to find recoverable data, and the RTO will determine how much time is needed for recovery. The Disaster Recovery plan must then be maintained through proper documentation and system validation.