Idialis Storm

Trainings & Qualifications

• IATA: computer training; current certificate holder
• IATA: computer training; current certificate holder
• GCP CITI; current certificate holder• Medication injections (Since 2018)
• All patient related interviews, procedures, and contacts according to various protocols (Since Feb 2021)
• Consenting Patients (since Feb 2021)
• Inclusion/Exclusion review (since Feb 2021)
• Patient Recruitment (Since Feb 2021)
• Patient Retention (Since Feb 2021)
• Obtain Medical Records for PI review (since Feb 2021)
• Maintain study supplies (since Feb 2021)
• Watch over Rights and Welfare of the Patients (since Feb 2021)
• Attends Investigator Meetings (Since 2021)
• Assist PI in delegated duties (since Feb 2021)
• Electronic Diaries: sponsor- and vendor- provided training (since Feb 2021)
• Using Icebaths: in-house training, sponsor, & lab training (since Feb 2021)
• EKG Acquisitions: site training per cardiologist; lead placement per sponsor recommendations (since Feb 2021)
• EKG Transmission: per sponsor & vendor training; both computer/phone line (since 2022)
• Nasopharyngeal swabs: training by sponsor-provided videos and materials (since Feb 2021)
• Vitals: include temp, wt, ht, BP, HR; site training; manual/automatic BP; oral, temporal, auricle temp (since Feb 2021)
• Electronic source documents: sponsor and vendor training (since Feb 2021)
• EDC Experience: sponsor training; includes Medidata Rave, InForm, Oracle, Calyx, Integrium, Medrio, Science37, ClinTrak, eCaselink
• Performs Artirial Velocity (since 2022)• IXRS; sponsor training (since Feb 2021)

Clinical Research

• Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (BROADWAY): A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Underlying HeFH and/or Atherosclerotic Cardiovascular Disease Who are Not Adequately Controlled by Their Lipid-Modifying Therapies
• A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor Xia Inhibitor, Versus Apixaban in Participants with AF (LIBREXIA-AF) • TestCard Pregnancy Test Kit
• A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of REL-1017 for Major Depressive Disorder (The RELIANCE-II Study)
• A Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety of REL-1017 as a Treatment of Major Depressive Disorder (RELIANCE-OLS)
• A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Trail to Evaluate the Efficacy and Safety of a Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine in Infants Born to Women Vaccinated During Pregnancy
• A Phase 2b Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety and Tolerability of Zibotentan and Dapagliflozin in Patients with Chronic Kidney Disease with Estimated Glomerular Filtration Rate Between 20 and 60 mL/min/1.73 m2
• A Multicenter, Randomized, Active-Controlled Study to Evaluate the Safety and Tolerability of Two Blinded Doses of Abelacimab (MAA868) Compared with Open-Label Rivaroxaban in Patients with AF (AZALEA)
• Testosterone Replacement therapy for Assessment of long-term Vascular Events and efficacy Response in hypogonadal men (TRAVERSE STUDY)
• HPS-4/TIMI 65/ORION-4: A double-blind, randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease
• A Phase 1a/b Randomized, Single-Blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of Single Ascending Doses of AZD3427 in Healthy Volunteers and Multiple Ascending Doses of AZD3427 in Patients with Heart Failure (HFrEF and HF with EF > 41%)