Engaging, streamlined and relevant, targeted to your trial and each investigator’s skill level, delivered via a range of live, virtual, and hybrid approaches
With guidance from our Expert Consensus Panels, we have successfully established premier education and training programs for clinical treatment, academic research, and industry-sponsored clinical trials. Our operational teams are knowledgeable about regulatory requirements globally and across indications, providing you with guidance on risk/benefit analyses for each training approach. Our trainers are clinical professionals and university educators with post-graduate expertise in psychology, psychiatry, psychometrics, public health, and clinical research methodologies. Our core team is supplemented by a globally distributed network of local Key Opinion Leaders on whom we rely to deliver our training content in a locally relevant way.
Featured: Customized Training Tiers for Advanced and New Investigators
Our teams use our extensive rater training database, currently counting over 10,000 investigator records, to assign investigators to customized training tiers based on their experience and qualifications. Comprehensive training tiers provide extensive support to new investigators, while our advanced track ensures that investigators with more experience are credited for that experience and receive training relevant to their level of expertise. This approach reduces the redundancy of training and the burden of start-up. Some investigators can be credited for recent training and are able to complete training on your study more quickly while meeting the same exacting quality standards as the rest of their study cohort.
Featured: Culturally Competent, Regionally Adapted Training, Standardized for the Global Environment
Locally based expert trainers are essential to the success of multi-national trials. Our core team at ProPhase works with a calibrated, diverse team of more than 200 international trainers based in over 50 countries across Europe, Asia, North America, Latin America, the Middle East, and Africa. We collaborate closely with members of our network during each stage of the study, from program design through execution. In doing so, our training is not only standardized and generalizable across regions within a global trial, but also meaningful and useful in the rater’s local context.
Featured: Applied Training Approaches, Including Individualized Simulations
Standard training usually involves viewing didactic modules and patient interview videos that showcase superior interview technique. Yet, research shows that interview technique has the largest impact on rating accuracy and, more importantly, on the rater’s ability to detect signal. This is because technique impacts multiple facets including: the quality of information generated for scoring purposes, and reductions in “therapeutic” interactions that drive placebo response. However, applied training in interview technique is rarely implemented on global trials due to cost and timeline concerns. We have developed an operationally efficient and cost-effective way to provide each rater with individual review of their assessment technique, using a standardized patient (actor) and structured feedback from the trainer. To date, we have conducted several thousand individual training sessions in over 28 languages across multiple adult and pediatric populations.
Investigative Site Staff and CRA Training
Training of Investigative Site Staff and CRAs
In addition to training raters, ProPhase is actively involved in training of Clinical Research Associates (CRAs), study coordinators, and other relevant site personnel. We provide site staff and CRAs with a dynamic, structural understanding of key components of our training and in-study quality assurance programs, as well as scale management activities. The goal of our CRA training efforts is to ensure that all CRAs have the information that they need to adequately support rater activities at the sites.
Patient and Caregiver Training
Training of Patients and Caregivers to Improve Validity of Patient and Caregiver Reported Outcomes
Collateral informants have been central to many traditional measures where self-report may be inadequate or biased. As caregiver and patient reported outcomes become increasingly more important in clinical research, standardizing these sources becomes a new goal. We provide clear and concise instructional materials in the patient and caregiver’s language, adjusted for comprehension level, in order to ensure that these instruments are used in a uniform and valid way, reducing the noise in these sources and improving signal detection.