The United States is the world’s largest market for pharmaceutical products and the majority of the industry’s research and development is conducted by firms based in the U.S. According to the most recent economic census, more than 810,000 people are employed in the biopharmaceutical industry in the U.S. and approximately 4.2 million people worldwide. Individuals employed in the pharmaceutical industry are highly skilled, and must routinely learn how to use new technologies, processes, and standards.
Loughner and Associates has designed and developed highly technical learning solutions for a variety of global audiences in the pharmaceutical industry.
- Research and Development
- Clinical Trial Management
- Clinical Data Management
- Investigator Site Personnel
- Biostatistics and Clinical Programming
- Clinical Research Physicians
- Regulatory Affairs
- Drug Safety
- Medical Communications
- Medical Affairs
- Supply Chain
- Manufacturing Operations
- Sales and Marketing
Loughner and Associates designed and developed training for the global implementation of clinical data analysis and reporting technologies. Training focused on the use of new harmonized processes, CDISC standards, and new technology platforms. The global audience included biostatisticians, statistical programmers, data management professionals, and members of clinical study teams. Deliverables included eLearning modules, Instructor-led training, and quick reference guides for both early adopters of the technologies and final implementation.
Loughner and Associates designed and developed training for a pharmaceutical company’s core laboratory for digital electrocardiogram data capture, transfer, and analysis for safety monitoring and regulatory submissions. Instructor-led and eLearning programs were created for a variety of roles with responsibility for Phase I trials including clinical study teams, nurses, and cardiologists. The Instructor-led content areas included study setup, user administration, metadata approval, analysis, exports, and reports. The eLearning focused on metadata approval and was implemented globally at clinical research organizations conducting Phase I clinical trials.
Loughner and Associates developed the curriculum, and designed and developed the training for the integration of six new technologies into clinical trials, conducted in more than 40 countries. In total, 25 job roles, both at investigator sites and the pharmaceutical company, were impacted by the integration of the new technologies and process redesign. Deliverables included just-in-time eLearning modules, Instructor-led training, quick reference guides, and user guides. The just-in-time modules made it possible for learners to complete the training close to when they would use the new skills during the clinical trial. Loughner and Associates also evaluated and selected the eLearning authoring tools used to develop the training for delivery to the global audience.