Case Study – Building Site Relationships with Inspection Readiness: Sponsor Soars with Trifecta’s On-Demand Training

InvestigatorSpace® Online Training Delivers convenience, quality & savings to drive site preference for clinical trial partnership

Overview

A large Top 10 Pharmaceutical sponsor engaged Trifecta to collaborate on training innovation to drive positive site and investigator experiences. Sites required a solution to address training redundancy, version control problems, validation, distribution and communication. In addition, tracking of training was cumbersome and created significant administrative burdens for study teams. Sponsor engaged Trifecta to reduce each of these pain points and deliver an easy to implement solution for sponsors, sites and study teams.

Executive Summary

 

Customer Top 10 Pharmaceutical Sponsor
Scope Create online, on-demand training solution for investigators/study teams to complete training while eliminating redundant training and allowing administrators to track on-going compliance in real-time.
Timing Implemented in 2010, InvestigatorSpace is part of Sponsor’s ongoing best practices
Key Stakeholders Investigators, Sites, Study Teams, Information Technology, TMF and Records Management, Quality, Global Clinical Operations, Global Training Management
Results Improved Site Relationships: Allows sites the convenience to train “the way they want to train” using Trifecta’s InvestigatorSpace on-demand training technology

Perpetual State of Inspection Readiness: Maintain state of inspection readiness 24/7 for all training activities and communications surrounding investigator training

Significant Time/Costs Savings: Reduced administrative burden, travel & meeting costs eliminated when using on-demand training option

Challenge

  • Drive innovation to deliver on Sponsor’s commitment to serve as a true partner for sites
  • Accelerate training by allowing investigators to train “on their own time”, anytime, anywhere, on-demand, eliminating redundant training and tracking training exemptions through the system
  • Ensure quality while reducing the likelihood of 483s issued during an inspection due to training*
  • Realize significant cost savings and return on investment

Results

TRAINING ACCELERATION FOR FASTER STUDY START UP

 

NPS LIBRARY CREATION: A LIBRARY YOU’LL WANT TO CHECK OUT
Trifecta delivered a library of standardized, non-protocol specific training to be used across all studies for the sponsor, including boilerplates for SAE Reporting, INFORM and GCP. Standardized GCP Library of >10 NPS modules created to be used for all studies.

 

TRAINING MODULE PRODUCTION TO TRAINED STUDY TEAMS IN 5 DAYS Sponsor leveraged Trifecta’s vertical integration to deliver training within 5 business days from training capture to commencement of training for investigators. Sponsor regularly engages Trifecta production services to complete the capture of training at live, face-to-face meetings in addition to the ability to record training modules in Trifecta’s Indianapolis Studio. All modules are produced and edited and placed on the portal for study teams to complete training in as little as 5 days.

 

ON DEMAND, ONLINE TRAINING AVAILABLE 24/7 GLOBALLY

Investigators + sites given the ability to training on their own time, anytime anywhere, driving savings in time, travel and admin burden.

 

REDUNDANT TRAINING ELIMINATED WITH CERTIFICATION/COMPLIANCE DIRECTORY

Based on unique requirements of the sites communicated to the sponsor, Trifecta delivered a Certification and Compliance Directory (CCD). The CCD tracks investigator training across studies and allows sites to upload documentation for credit. Since inception, the CCD is estimated to have saved >100,000 hours.

Training Quality Improvement

 

ENDURING TRAINING ASSET CREATION

On-Demand training allowed Sponsor to create an enduring asset. Over time, this asset can be referenced by study teams, investigators and CRAs to quickly train new sites and personnel due to site & CRA turnover.

 

CONFIDENTLY SHARING A CONSISTENT & PRECISE TRAINING MESSAGE

Sponsor is now able to deliver the exact same training at every training opportunity. This consistency in message reduces risk of errors or improper communication of important training topics. In addition, training materials can be reviewed for errors prior to distribution and updated as needed.

 

AVOIDANCE OF LOGISTICAL DISRUPTION

Opportunity costs of attending face-to-face meetings can be high, making perfect attendance difficult to achieve. Using Trifecta’s On-Demand training, control over when and where training is conducted is given to the investigator or study team without being beholden to travel to a meeting in person or an inconvenient webinar schedule. This not only saves time, but allows teams control over their time.

Time Savings

 

SITES TRAINED AS SOON AS THEY ARE READY

With On-Demand training, protocol training is available as soon as the site is ready, saving valuable time and resources for sponsor and sites. This resulted in the reduction of sponsor costs to keep sites open, reduction of overall training and CRO costs as well as accelerated timelines to database lock. Inevitably, some sites do not come into the study until after the Investigator meeting has been conducted. In this case, Sponsor can provide a solution to sites that does not disrupt timelines.

 

In the example below, ten sites are preparing to begin a study. Twenty days from the Investigator Meeting, many of these sites are ready to begin enrollment but are awaiting protocol training either at the live meeting or webinar. In essence, they are waiting on training before they can begin the study.

SITES ARE READY AT DIFFERENT TIMES—INCLUDING AFTER THE INVESTIGATOR MEETING

By contrast, when Sponsor uses Trifecta’s on-demand training rollout, training is ready as soon as the site is ready. In the example below, the study gains a potential 110 additional enrollment days. Even assuming a 50% realization, of actual enrollment days, the study could gain a minimum of 55 days of additional enrollment.

SITES THAT ARE READY SOONER GAIN ENROLLMENT TIME WITH ON-DEMAND TRAINING

Cost Savings

 

COST SAVINGS USING ON DEMAND TRAINING ARE SIGNIFICANT

Below, we compare and contrast the potential cost savings on demand training delivers over traditional investigator meeting solutions. Assumptions based on 150 sites (2 trainees per site) and 25 participants from Sponsor/CRO and three global face-to-face meetings.

ON DEMAND TRAINING DELIVERS ~75% COST ADVANTAGE OVER TRADITIONAL SOLUTIONS

ON DEMAND BUILDS STRONG SITE RELATIONSHIPS AND A PERPETUAL STATE OF INSPECTION READINESS

 

While there is no substitute for relationships developed in person, on demand training provides significant benefits over traditional solutions including In Person, Virtual and CRA/ Site Visit Training.

 

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