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Enabling Strong Clinical Operations Project Management Through a Digital Toolkit

A biopharmaceutical company specializing in rare diseases engaged Clarkston Consulting to help develop an innovative digital toolkit to support the management of activities for clinical studies. Historically, the client utilized Excel spreadsheets and leveraged email for sharing information between stakeholders. However, since these manual activities caused delays and inefficiencies, the client wanted a more efficient way to oversee projects and share information transparently across the entire organization. To mitigate this, Clarkston built a digital clinical operations project management toolkit that provided one centralized location to gather, collect, analyze, and report key project information.  

Download the Clinical Operations Project Management Case Study Here

After carefully reviewing various PMO tools and software programs, the client selected Smartsheet as the organization’s primary PMO tool. Clarkston leveraged the Smartsheet platform to create standardized templates for the Clinical Operations group to help them manage and track site activation and patient enrollment status. In addition, Clarkston built dashboards that provided real-time visibility to important clinical study information to the Executive Leadership Team (ELT).  

As a result, the digital management toolkit allowed the Clinical Operations team to:  

  • Enter information only once and leverage it across multiple reports or dashboards 
  • Simplify and automate data collection and gathering  
  • Provide a consistent approach to managing and tracking clinical studies 
  • Standardize how information is collected, viewed, and shared with ELT 
  • Improve visibility across all clinical studies   

With this innovative solution, the organization tracked more than eight clinical studies, resulting in more than 100 clinical trial sites activated and more than 300 patients enrolled across all studies.  

Overall, Smartsheet allowed the client to have a centralized place for data collection, standardized templates, and automated dashboards for management reporting. Clarkston has also started to launch this digital management toolkit in other non-clinical areas, intending to have the entire organization utilize Smartsheet as their project management tool by the end of 2023.  

Download the Clinical Operations Project Management case study. Learn more about our Project Management Services by contacting us below. 

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Contributions from Vanessa Villalpando

Tags: Case Study, Project & Program Management, Digital Strategy