Data Discernment – A simplified approach to strategic study & portfolio planning.

by Kelly Butler |
Aug 20, 2021 |

Historically, clinical outsourcing has negated the need for small-to-midsize Sponsors to maintain their own in-house Clinical Trial Management System (CTMS) application. With the evolution of adaptive protocol design and the increased importance of capturing, synthesizing and operationalizing on-going data points over the course of a study – to drive protocol amendments, risk-based study management, or acquisition/divestiture decisions – many Sponsors want more involvement and control in their study data, regardless of the outsourcing model.


Now, with the rapid innovation in eClinical system technology, a Sponsor can more readily find a CTMS solution that supports exactly their business profile – enhancing strategic insights without unnecessarily encumbering the clinical operations process.

Most small-to-midsize clients focus on two key areas when using CTMS to enhance data accessibility

1. Enrollment Metrics
Key Areas of Concern – patient recruitment and screen failure rate, open to enrollment to first patient enrolled, patients enrolled and not completing all visits (breakdown analytics for interim visits, safety events, and/or protocol deviations), target enrollment, accrual timeline.

2. Site Performance
Key Areas of Concern – study start-up timelines/spend, protocol compliance and deviations, safety reporting, data entry timeliness and accuracy, clinical document quality.

These two areas provide the greatest/earliest indication of protocol success or on-going risk, as well as return on study investment. And, so the question becomes, should the Sponsor bring the necessary data points in-house using CTMS as a nexus for cross-functional collaboration? Great question.

Use skills, experience, and resources of your CRO to your greatest advantage!

Essentially, CROs have a deeper data lake and access to more robust, well-rounded data points. It’s a volume game, pure and simple. Unless your organization has very specific goals in mind, it likely isn’t worth the cost and resourcesto duplicate the data collection efforts, particularly if the CRO has been contracted to perform a majority of the study activities.
Another important consideration is application maintenance. When the CTMS application is cloud-based and subject to periodic release updates – like Veeva Vault Clinical – any integration must be tested and maintained to ensure integrity of both the connection and the data communicated thereby. This can be a big resourcing effort, considering the 3x Annual Veeva Vault Release schedule.

Get specific and targeted with meaningful KPIs

When Sponsor goals dictate that it is time to bring data in-house (worth the implementation and maintenance efforts), be highly targeted. Choose specific, meaningful Sponsor-priority KPIs to capture in the CTMS environment, then leverage Vault application features to boost efficency in on-going management activities. Resist the urge to capture data simply because there is a visible field available or an out-of-the-box report associated with it; if you don’t need it, hide it.


In this blog series, we discussed the importance of a simplified eClinical system environment, then juxtaposed compliance „have-to-dos“ with strategic „want-to-dos“ using a simple framework, and voila – a hybrid governance:maturity map. Using this map, you’re ready to drive innovation both internally and within the industry. And, if you need some extra help, just ask – fme is here to support you!

About the author

Kelly Butler joined fme US as a Consultant in the Consulting Services (Clinical) Team in October 2020 and her bio accounts for her strong Life Sciences expertise. After graduating from the University of Minnesota, Mrs. Butler began work as an Account Executive for UnitedHealthcare and returned to school to pursue her law degree with a focus on healthcare compliance and bioethics. Upon graduation, Mrs. Butler relocated to Raleigh, North Carolina and began her foray into clinical operations specific to R&D in the life sciences space. Recognizing the potential for greater efficiency across clinical operations in leveraging emerging technology, Mrs. Butler shifted her focus to the nexus of biomedical science, technology, and the human element: eClinical Systems. As a Consultant and Customer Success Manager with Veeva Systems, Kelly secured her Vault Platform White Belt Certification through Veeva’s credentialing process, as well as a Privacy Law & Data Protection Professional Certificate from Penn Medicine, University of Pennsylvania Health System.

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