A multinational pharmaceutical company launched a major Stage 3 clinical trial to determine whether a new treatment was more effective than chemotherapy in improving outcomes for patients with advanced triple-negative breast cancer who couldn’t receive immunotherapy. For the trial to be successful, the company needed to quickly and effectively train 700+ principal investigators (PIs) and site staff.
Business Challenges & Goals
The client company’s commercial strategy was to transform patient outcomes in major tumor areas including breast, hematology, lung, GI, and GYN/GU. This trial was a phase 3 interventional study, enrolling a total of 637 patients.
The client team aimed to:
- Establish ongoing collaboration with local study sites
- Achieve enrollment targets and ensure operational excellence across all participating sites
- Provide ongoing education through a centralized learning portal for trial updates
- Reduce travel costs, and eliminate the administrative burden associated with traditional face-to-face or virtual meetings
- Ensure all stakeholders were fully trained, aligned on study protocols, and equipped to conduct the trial compliantly and efficiently across diverse regions and languages
Insights & Actions
The company used Within3’s Group Engagement Application to create a Clinical Virtual Learning Hub for essential clinical trial staff. Within3 created both an active learning hub composed of educational materials and knowledge-based questions, and a post-session hub that acted as a centralized knowledge repository to be shared with PIs and site staff.
On top of this, the client team received:
- A custom process that was established and refined based on their ongoing needs
- Weekly touchpoints between the client team and Within3 customer success
- A certificate of completion for each participant on completion of the training requirements
- Custom reports to track training progress and completion requirements
- Q&A calls for live engagement with PIs and site staff
- Custom registration for participants in Q&A sessions
“The Within3 team was very knowledgeable, always ready to help, and the platform was really easy to use,” the Global Study Associate Director told us. “This helped ensure clear, consistent training and smooth communication across all sites – leading to successful vIMs and stronger protocol adherence, which helped achieve enrollment.”
Business Results & Metrics
The client team experienced the impact of Within3’s Group Engagement Application in three main areas: time savings, cost savings, and greater collaboration and connectivity across the trial team. “The Group Engagement Application offered a scalable, repeatable model for engaging and training large teams, with full tracking and documentation to meet audit requirements,” the Global Study Associate Director told us. “When preparing for an EMA inspection, the team was able to access all required documentation through the platform easily.”
The Clinical Virtual Learning Hub enabled:
- 700+ participants to complete the training at their own pace
- Virtual Investigator Meetings (VMIs) for direct, frequent contact with investigators
- Centralized access to training materials and documentation, study updates, newsletters, and study documentation
- Tracking of training completion and engagement to ensure trial readiness and compliance
- More effective communication of protocol requirements to ensure information was clear and compliant
- Multilingual support for a diverse global team
It resolved operational challenges in real time and remained audit-ready, with detailed documentation of site readiness and communication logs.
–Global Study Associate Director
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