Clinical Research Training for Clinicians
Empowering Tomorrow's Investigators through Training and Support
Join Us in Shaping the Future of Healthcare
Primary investigators are at the forefront of developing groundbreaking therapies that have the potential to save lives and improve patient outcomes. By partnering with us, you’ll be instrumental in advancing research that could change the course of treatment for countless individuals—including your own patients.
Together, we can push the boundaries of what’s possible in healthcare. Your expertise, combined with our training, resources and support, will drive innovation and bring promising therapies to those in need.
Let’s work together to make a lasting impact on the future of healthcare. Reach out to learn more about how we can help you contribute to this vital mission.
Our Approach
We effectively deliver comprehensive training that covers investigator responsibilities, understanding regulatory and ethical guidelines, and the scope of an Investigator’s oversight expectations in a clinical trial. We want to help turn you medical expertise in standard of care into an incredible tool for clinical trials. Let us help you start your clinical investigator journey with one of our members who meets your needs and is available to see you, online or in-person.
Our Services
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Investigators must complete ICH E6 and FDA GCP training courses, they cover the ethical and scientific quality standards for designing, conducting, recording, and reporting trials. It ensures that trials are conducted in accordance with regulatory requirements and ethical principles. This training may need to be updated periodically.
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Collaborative Institutional Training Initiative (CITI) courses, which cover IRB processes, informed consent, and ethical considerations. In the U.S., this training aligns with guidelines from the Office for Human Research Protections (OHRP).
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Training in compliance with FDA regulations (21 CFR Part 312 for investigational new drugs) and guidelines. This includes understanding requirements specific to the trial's location and jurisdiction.
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Training provided directly by the pharmaceutical company sponsoring the trial, which may include protocol-specific workshops or online modules. Detailed review and training on the specific clinical trial protocol provided by the sponsor, including training materials and protocol manuals.
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Training on using Electronic Data Capture (EDC) systems like Medidata Rave or Veeva Vault, as well as CRIO (medical recording software platform) and safety reporting systems for adverse events (e.g., FDA Adverse Event Reporting System (FAERS)).
