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Health Sciences
May 21, 2020
Fear of Failure Mindset Limits Opportunities to Innovate
Virtually all leaders believe that to stay competitive, their enterprises must learn and improve every day. Learning comes from failure, from earned experience. The 'fear of failure' mindset limits opportunities to innovate.
While many life science vendors espouse the popular promises of reductions in cycle times, improved collaboration and operational oversights in study startup, only a rare few can deliver.
With pharmaceutical and CRO organizations steadfastly focused on success at all costs this realization is often overlooked to the detriment of their performance when selecting vendor partners. In-depth industry experience and a willingness to learn and innovate, are therefore essential factors to be considered during the vendor selection process.
Embrace a culture of continuous improvement and discovery
Collaborative strategic partnerships between sponsors and CROs are essential for tacking the treacherous study startup journey, our learnings include:
- Establish trust early: Central to establishing trust is to integrate stakeholders early in the decision-making process. It's all about accountability, transparency, and communications.
- Solicit feedback from all stakeholders impacted by the technology: This allows for mutual buy-in and helps with change management, which can dramatically increase the likelihood of the technology being effectively utilized after deployment.
- Jointly manage responsibilities and change: Proper on-boarding is essential for the adoption of any new technology, preparing the clinical operations team for the inevitable changes requires in-depth training and around the clock support.
- Go deep: Take the time to have a deep understanding of the processes, challenges, concerns and potential resistance. Automated workflows need to be customized to the sponsor/CRO SOPs, these extend beyond country-specific regulatory requirements and ensure overall compliance. Properly configured workflows that automatically guides the execution of activities will ensure a streamlined flow of documents and gains in operational efficiencies.
- Capture and share insights: The true benefits from automation come from the actionable insights they delivery as a result of transparency into processes. Real-time data proves an opportunity to highlight and prioritize processes ripe for optimization.
- Think globally, lead responsibly: Regulatory and ethical submissions differ between countries, necessitating replicated tasks for each specific country. It’s crucial to automate these workflows so that mistakes are minimized and that resources can be efficiently utilized.
The road ahead
Just as stakeholders are embracing technology to drive process improvement, major regulatory agencies are promoting these efforts, as well. The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have released documents on greater acceptance of technology early in the clinical trials process as it relates to risk-based monitoring. The FDA guidance encourages sponsors to take advantage of the innovations in technology to enhance protection of human subjects and for better study oversight and conduct of clinical trials. The EMA Reflection Paper cites the importance of systematic use of information to identify risks, which includes data from electronic tools such as EDC, interactive voice response systems (IVRS), and electronic case report forms.
A major follow-up to these regulatory documents is the International Conference on Harmonisation – Good Clinical Practice Guideline (ICH-GCP) E6(R2) guideline, combines the risk- and quality- based principles described in the FDA and EMA guidance’s. Its purpose is to draw attention to the increasing complexity of clinical trials, and how the ongoing evolution in technology allows for more efficient quality management and risk assessment, starting with study startup.
To align with recommendations in these regulatory guidance’s, industry leaders have been transitioning away from their Excel spreadsheets, and toward custom-built study startup applications that provide project management functionality.
They are gaining ground with stakeholders anxious to shorten timelines and rein in costs, all in an effort to speed sought-after therapies to patients around the globe — giving way to transparency, operational improvements, and greater collaboration from the very start.
Learn more about optimizing your study startup.
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