A Cohesive Solution to Manage Clinical Trials’ Protocol Deviations During Covid-19
CASESTUDY
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Our Customer
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AT A GLANCE
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An American provider of biopharmaceutical services who conducts clinical trials on behalf of its pharmaceutical clients to expedite the drug approval process.
Business Challenges
Deviations from the approved trial protocol are common during clinical trials. The client, a Clinical Operations Leader, found the overall management challenging as they work on an average with 15 systems, 10-12 SOPs, numerous forms, templates, checklists, and manuals for 3-4 trials simultaneously.
A protocol deviation occurs when, without significant consequences, the activities on a study diverge from the Institutional Review Board-approved protocol. The current industry trends given below indicate immediate attention towards deviations and amendments.
The client needed to ramp up digital channels urgently — web and Mobile messaging, 3rd party chat and messaging channels including Facebook Messenger, WhatsApp, SMS (1-way / 2-way), Apple Business Chat, LINE, Kakao Talk and WeChat and live chat.
According to FDA, protocol-mandated visits, laboratory/diagnostic testing, and use of the investigational product are the key types of protocol deviations anticipated from COVID-19
88% of CROs, are investing in remote trial monitoring solutions causing multifold protocol deviations
Deviations can have an impact on delaying some assessments for ongoing trials to stopping recruitment or withdrawing participants
On average, clinical trials with at least one substantial protocol amendment took 3 months longer to complete than those without an amendment
Tufts CSDD estimates protocol amendments cost the industry a total of $20 billion a year in direct and indirect costs
Our Solutions
Our Solution
Hexaware proposed a holistic solution to manage COVID-19-related protocol deviations and amendments happening during COVID-19 and a centralized hub to monitor clinical trials.
The first step was to set up a unified employee and sponsor experience.
OUR SOLUTIONS
Highlights of the cohesive solution:
• Unified study view • Prebuilt workflows aligning to study protocols • In-built reminders and approval process flows • Dashboard with meaningful metrics and the ability to drill down on information from multiple systems for a given project • Ease of collaboration with peers • Quick links with SSO capability • Mobile-enabled
Our team of experts built a ‘study execution hub’ platform leveraging business process management tools to optimize clinical trials oversight and management of protocol deviations. We leveraged automation with prebuilt guided workflows driving end-to-end and seamless study operations oversight. One of our focus areas was to enable the business users to connect to the mobile-enabled Hub App for centralized study and site monitoring. We could fast-track time-to-market with low-code platforms.
• Unified study view • Prebuilt workflows aligning to study protocols • In-built reminders and approval process flows
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Business Benefits
HIGHLIGHTS
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Our holistic solution for deviation and amendments management led to excellence in clinical trials operations, effort reduction, and performance improvement.
85% of interactions previously through calls are now routed through chat
30% faster onboarding with automation and other enhancements like quick routing
Increase in customer satisfaction through focussed data to insights
Reduction in number of licenses. 30% faster onboarding with automation and other enhancements like quick routing 85% of interactions previously through calls are now routed through chat
Cohesive solution aids in more efficient operation across multiple enterprise levels
Significant effort reduction in managing protocol deviations
Minimized manual errors
Improved employee performance and efficiency
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