Our Global Clinical Education & Strategic Programs team is dedicated to partnering with you to provide strategic site training solutions.
Site training is critical in achieving successful clinical development results and protecting the safety of patients. Clinical trials are becoming increasingly complex due to the growing number of global trials needed, more stringent eligibility criteria and the increasing quantity and complexity of endpoints required per study. This complexity means effectively training site staff to ensure patient safety and protocol compliance are more important than ever, especially with increased scrutiny from regulatory agencies. The FDA Guidance on Investigator Responsibilities – Protecting the Rights, Safety and Welfare of Patients – outlines the importance and need for proper training on all delegated study tasks and maintenance of training records for all investigator and site personnel involved in randomizing patients.
We deliver unique, strategic clinical education programs
Our global in-house Clinical Education team is dedicated to providing our sponsors with innovative, cost effective and compliant Clinical Education Programs for Phase I to IV clinical trials:
- Comprehensive Investigator Meeting Program Management
- Clinical Education Plans to document study compliance with ICH/GCP Guidelines and global regulatory guidance on investigator responsibilities
- Clinical Education ePortals with unique methology to track site training based on tasks delegated
- Clinical Education Web Conferences
- Steering Committee, Advisory Board & National Coordinator Committee Program Management
Our offering is unique – we work with you to develop a tailored and consistent strategy for training site staff perfectly suited to the needs of your study. Clinical education is so vital to study success, we’ve made it an integral part of our proven Trusted Process® QuickStart® phase, helping you create customized Clinical Education Plans aligned with country start-up times.
Connecting our Sponsors to Sites
Building strong relationships with sites is a fundamental goal at INC Research. Our global team is dedicated to providing innovative, cost effective and compliant Clinical Education Programs that connect our sponsors to sites. Since site engagement and retention of study training is so crucial, we work closely with sponsors to build interactive programs that engage the audience and reinforce key learning points for the study.
Planning for Study Success Through Site Training Compliance
We work with you to develop a tailored global Clinical Education Plan perfectly suited to the needs of your study. This plan documents the process to ensure your site staff are trained on all applicable tasks delegated for your study. A study specific Site Training Matrix is developed that details training requirements for each study task. This is used to program the ePortal to assign each User’s unique training requirements. All external and prior training accepted is defined in this plan as well.
Our secure, 21 CFR Part 11 Compliant, study-branded ePortal provides site personnel with the training, tools and resources required to proactively complete and monitor site education. By configuring the ePortal to the needs of your study, we can:
- Manage clinical education completion study tasks (based on the Study Training Matrix)
- Track investigator meeting and Site Initiation Visit (SIV) attendance and other external training completed via third-party rater / assessment portals to provide consolidated reporting
- Provide training conducted at the investigators’ meetings for those who could not attend
- Conduct assessments to document knowledge transfer
- Track previously completed non-study specific training (i.e., ICH/GCP, IATA, study assessments, etc.) to reduce redundant site training and apply efficiencies
- Provide study-specific documents and forms
- Provide links to other study websites applicable to the study with single-sign-on capabilities
- Generate certificates of completion (especially useful when it comes to training audits)
- Provide real-time site training compliance metrics and key site performance metrics
Our Clinical Education ePortal can also be Integrated with Patient Recruitment Portals to provide a streamlined portal for sites to access. Single User Authentication (APIs) can be also be written with other systems (i.e., Medidata) to further streamline the number of systems sites must access for your study.
Our mission is to produce best-in-class clinical education programs for our sponsors to educate study personnel on the protocol and all study procedures, to facilitate patient safety, study compliance and data consistency.
Our approach is recognised as being excellent, evidenced by INC Research earning the title of “Top CRO To Work With” among large global CROs for two consecutive years, the most recent at the 2015 CenterWatch Survey of investigative sites.
Work with us today, and through robust clinical training we’ll ensure your sites are ready to start when you are, while avoiding any future audit issues.