Meet Our Instructors
Raina Agarwal has over 12 years of experience in clinical trial transparency, medical writing and medical information domains, including a depth of expertise in clinical trial registrations, results posting, maintenance, and data-sharing requirements for ClinicalTrials.gov, EudraCT, EU PASS, and other mandatory international registries. She has successfully led a number of anonymization and redaction projects required for EMA Policy 0070, EMA Policy 0043, Health Canada PRCI, FOIA and voluntary data-sharing requirements for journals, CSDR initiatives, and company websites, among others.
As Senior Manager of Transparency at TrialAssure, Raina is directly involved in developing standard operating procedures, working practices that adhere to clinical trial transparency regulations, and conducting on-site workshops and training to effectively communicate best practices and efficiencies to sponsor teams and new clinical trial disclosure colleagues. She has been instrumental in evaluating the impact of new and evolving regulations on the sponsors’ studies and submissions. Collaborating with TrialAssure strategists and developers as an SME, she proposes system enhancements and tests new and upgraded features in the TrialAssure REGISTRY and ANONYMIZE software. Raina is committed to providing robust transparency services and technology platforms to sponsors, enabling them to achieve compliance.
Raina has presented on multiple occasions in DIA-Clinical Trial Disclosure Community Meetings and conferences. In addition, she recently published an article in the European Medical Writers Association Journal on evolving clinical data-sharing regulations like EU CTR 536/2014, HC-PRCI submissions and EMA Policy 0070. Raina holds a Master’s in Pharmacy from Birla Institute of Technology and Science, Pilani, Rajasthan, India.