IN PARTNERSHIP
the early observations and signals for accelerating analysis you notice certain cohorts are not responding. You then have the chance to pivot with the remaining $8m to the cohorts that are responding instead of spending the whole $10m on your study’s non-responders. Let’s take a quick look at the story of a biotech
company that was able to complete its Phase III study months earlier than planned, hit its clinical milestones, complete an initial public offering (IPO), and even out-license its product before the trial was complete. A biotechnology company (the Company) was based in the US and had a breakthrough drug candidate with a potential market value in excess of $5bn. The Company sought to capture that value by out-licensing X-US rights and through an IPO.
In order to realise the potential value of to successfully complete a one-year Phase III clinical study of the drug involving 200 enrolled patients at 45 investigator sites. In addition to achieving a successful outcome, the complex study also needed to be completed as fast as possible to conserve the Company’s existing capital, meet a milestone for an $80m funding event, and conduct the IPO within the planned time frame. However, the Company had serious concerns
since about 45% of all Phase III studies fail and far more are delayed, and it had previously experienced dissatisfaction with the norms of CROs in their other projects. The Company sought improvement on those norms for clinical study success, data quality, and speed by working with Prevail InfoWorks. This involved supporting the Phase III study with Prevail’s information, data, and process expertise, as well as nearly a dozen sign-on dashboard. Unlike a static report, reporting engines allow you to generate a report the minute you decide you want it, without time and programmers standing between you and your patient data.
The Single Interface® included: • Start-up and regulatory administration • Screening and enrollment • Document management • Project management administration
• Early safety signal detection • On-site and remote monitoring • Data cleaning status • Data integration and aggregation • Supplies management and global logistics
• IxWR administration • Clinical site and monitor to-do list
The Company was provided a single point of access and an accelerated analysis of the live data because it was automatically consolidated and reconciled, including from eCRFs, re-supply logistics systems, interactive web response systems, labs, ECGs, safety databases, and electronic patient dairies. In addition to the numerous standard reporting engines that were available to them, the Company was able to make informed study decisions based on 15 categories of customized reporting engines, ranging from a Cell Sample Report to Visual Beyond a successful clinical outcome (p < 0.001), Prevail’s norms resulted in study completion at least 110 days earlier than usual while maintaining the highest data quality. The early visibility enabled the Company to attract a licensing partner who paid over $700m for X-US rights to the drug before the study was completed. The quality of the data also supported its publication in the New England Journal of Medicine.
For more information on Prevail InfoWorks, visit
www.prevailinfoworks.com and schedule a walkthrough of its end-to-end pharma services, full eClinical Suite and other technologies.
References 1. Biotechnology Industry Organization. BIO/BioMed Tracker Clinical Trials Success Rates Study. CEO & Investor Conference. 15 Feb, 2011.
2. Dr Thomas Bart. Comparison of Electronic Data Capture with Paper Data Collection. Pharmwatch. 2003.
3. Kola and Landis. Can the pharmaceutical industry reduce attrition rates? Nature Rev Drug Discovery, p711-715 (2004); Practical Guide to Clinical Data Management, Second Edition, p66.
4. Fitzmartin RD. Drug Information Journal 2001; 35:671-679.
5. Joanna Glasner. Biotech Startup Funding Has Also Slowed in 2022. Crunchbase News. 2022.
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