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2012 Clinical Training Survey: Globalization & Technology Trends Driving New Models
As clinical trial designs continue to incorporate a Quality by Design approach, clinical operations and clinical quality assurance teams may benefit from the lessons learned from QA teams within the manufacturing area: a well-defined, role-based training program can reduce the risks of non-compliance, while improving site quality.
In this paper, we share results of a survey conducted with clinical professionals from a wide range of Pharmaceutical and Medical Device organizations, as well as CROs, to understand the forces that are shaping the way training is being delivered to internal study teams, site personnel and other parties involved in sponsor-driven clinical research.
Here are two of the results from the survey:
Training Topics Being Conducted:
Capturing Clinical Training Records:
Three factors are compelling clinical operations teams to incorporate online tools within their site communications and training programs, as opposed to relying solely on in-person or face-to-face programs:
- Global trials have become the “norm”, and this requires that first-time investigators and staff in developing regions gain qualifications in an accelerated timeframe.
- The expanding relationships of sponsors and Contract Research Organizations (CROs) means that training and communication programs now serve as recognized differentiators, rather than one-time compliance events.
- The advent of new technologies and other eClinical-related methods now require technologies, available 24/7 and serving as “performance support” references for site personnel; this is especially true for site personnel that miss any initial study orientation because the site was added to a trial following initial study setup.