After a year of unprecedented and transformative adaptation in clinical research, on the 5th of February 2021 industry experts come together to share their collective reflection on decentralized trial modalities and the role they will play in securing the advancement of tomorrow’s research. Join the conversation as we discuss remote modalities across the lifecycle of a trial covering topics such as:
- effective trial feasibility and planning,
- patient recruitment,
- regulatory compliance,
- continuity of operations,
- leadership’s role in empowering emotional resilience, and
- the role technology will continue to play in shaping decentralized trials;
Raymond Nomizu is the co-founder of Clinical Research IO, a site-centred electronic Source and CTMS solution. Clinical Research IO allows research sites to collect data accurately and contemporaneously and sponsors to view the data in real-time, without costly source data verification. Prior to founding CRIO, Raymond owned and operated an independent clinical research site, co-founded a real estate data analytics firm, and served as a management consultant focusing on process improvement. Raymond has AB and JD degrees from Harvard University.
Edye T. Edens, JD, MA, CIP, CCRP is the Senior Research Compliance Consultant at First Class Solutions focusing on research compliance and life sciences. Edye is a licensed attorney with an international human rights, research ethics, and health law background. Her consulting services include research administration, healthcare compliance, grants/contracts to IRB, COI, education, privacy, HIPAA, multiple areas of FDA compliance related to drugs, devices, and food; AAHRPP, misconduct, and site-level compliance work as it relates to QA, monitoring, and auditing (particularly oncology).
Maya Zlatanova is a clinical research entrepreneur and the co-founder of FindMeCure Ltd. The company has been focusing on data intelligence tools to support operational teams to better plan clinical trials closer to patients. FindMeCure’s platform – TrialHub, is the first one to connect sites with experience in remote support to patients with potential decentralized trials and supports the decision-making process around technology deployment in 70 countries. Mrs. Zlatanova has been also advocating for improving patient recruitment through easier access of patients to clinical trials information and direct-to-patient strategies.
Daniel Perez is the Chief Operating Officer at MACRO Trials. MACRO is a Site Optimization Organization (SOO) dedicated to providing the institutional infrastructure to perform the highest quality clinical trials across all specialties and private settings. At MACRO, Daniel combines his operational acumen with research and regulatory expertise to help bring its vision into a tangible reality. He leads MACRO’s operations by constantly challenging the status quo, and continuously evaluating the clinical trial process through the lens of the patient. Daniel also serves as a founding board member for Clinical Trials in Color, a 501(c)(3) non-profit foundation with a mission to improve health outcomes in communities of color by increasing diversity and access to clinical trials.
*The webinar is prerecorded and will be available as a recording on the 5th of February.