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.
Collaborative strategic partnerships between sponsors and CROs are essential for tacking the treacherous study startup journey, our learnings include:
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.
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