ePharmaSolutions’ team of clinical, medical, and systems trainers have been helping global pharmaceutical companies improve protocol, study procedure, and clinical systems training for more than a decade. Over the last 10 years, ePharmaSolutions has trained and/or certified more than 190,000 clinical researchers in 107 countries on all aspects of clinical research. The training can be delivered in person or online and results in more significantly improved learning outcomes than traditional methods.

The Process
ePharmaSolutions integrates interactive adult-learning methodology with best-in-class technology and learning tools to provide a more interactive learning experience for end-users while improving comprehension rates and verifying training completion and comprehension for compliance purposes. Our training solutions break down into three categories: Content development, content deployment, and content delivery and tracking.

Content Development
Our team of clinical subject matter experts includes MDs, PhDs, and instructional designers who are all seasoned clinical research professionals who understand the complex, technology driven clinical trials environment from both the sponsor and site perspectives. This experience allows ePS to offer clients a flexible training model that outsources all content development to ePS (protocol review, slide development, knowledge check/assessment development, speaker coaching, etc.) or offer more of a consultative approach (slide review, knowledge check/assessment development, speaker coaching, etc.). In either case, the goal is to ensure the content properly trains all of the stakeholders involved to meet compliance requirements without overburdening them.

Content Deployment/Logistics
ePharmaSolutions handles all aspects of training delivery, from scheduling and logistics to user account management for eLearning and online meetings. Once the content is developed and approved, it is important to deploy it in a way that is simple and easy for stakeholders to access and complete. ePharmaSolutions has a team of training logistics managers who ensure that the training is scheduled, the user is properly informed of how and when to take the training, and is properly credentialed into the systems. This includes attendance at in-person and/or moderating online Investigators’ Meetings, management of audience response units, and working with AV teams to ensure meeting content is recorded into archives for future use.

Content Delivery and Tracking
All content is delivered and tracked through ePharmaSolutions’ Part 11 compliant Learning Management System (LMS). The LMS is a role based application that is part of ePharmaSolutions' award winning Clinical Trial Portal solution. The LMS tracks the on and offline training of more than 190,000 clinical researchers in 107 countries and tracks the progress and completion of training for each user across protocols and across sponsors. The system has an extensive array of features that has been put to the test on more than 2,000 clinical trial projects over the last 10 years and has passed dozens of sponsor and regulatory audits/inquiries.

Our Areas of Expertise
ePharmaSolutions has extensive experience in developing high impact training and certification programs in the following areas:

Protocol/Study Procedure – Slides, modules, case studies, tools
GCP & Process Training – Investigator Meeting slides, modules, certifications
Systems Training – EDC, IVRS, CTMS, etc.
Rater Training – Every major psychometric scale
Therapeutic Training – Over 160 courses in every major indication
Patient Education  – Informed consent, patient recruitment education, etc.
Study Tools – Visit at a glance, calculators, helpful resources, etc.

Our Results
Over the last decade, ePharmaSolutions has measured the effectiveness and adoptability of most every type of clinical research training methodology at the global level. This has resulted in a best-in-class training solution that is second to none in the clinical trials space with regard to improving protocol and clinical systems comprehension rates. In today’s competitive and complex, technology driven clinical trials environment, it is exceptionally important that study teams clearly understand the protocol/procedures and can quickly master the technologies used. Proper training ensures user adoption and improves overall site satisfaction. In fact, one of ePharmaSolutions major pharmaceutical clients compared traditional protocol training to the methodologies ePharmaSolutions deploys on over 30 clinical trials. The data suggests that sites trained using adult learning and technology-enhanced training had 80% fewer data queries and 30% fewer GCP issues than those trained at traditional in-person Investigators’ Meetings on the same compound. In addition, sites have stated that “better training on the protocol and clinical trial systems” is one of the top 3 things that sponsors could provide that would have substantial impact on their ability to succeed in conducting clinical trials (single sign-on was #1 and faster study start-up/contracting process was #2 in the annual IRM survey conducted with over 2,000 sites).

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