Clinical Services Medical Monitoring

Medical Monitoring

CTI’s Medical Affairs team consists of well-diversified medical professionals to cover all aspects of patient care, as the majority of our studies include highly complex, critically ill patients with a high incidence of co-morbidities and expected medical complications. Our team has extensive clinical, academic, and Phase I-IV clinical trial experience, in addition to decades of experience in the industry. Their relationships with site personnel is imperative to site and subject recruitment.

William Aronstein, PhD, MD, FACP
Vice President, Medical Affairs
Dr. Aronstein's training at Johns Hopkins as well as other renowned institutions has provided the opportunity to develop relationships around the world, giving CTI significant reach within these important but small medical communities of rare diseases.

William Aronstein

Our medical monitor coverage is designed to assist the sites with study related questions, such as safety reporting issues, discussions regarding inclusion/exclusion concerns and deviations, safety trending analysis, and patient management questions.

The CTI Medical Affairs team provides insight into clinical practice at all phases of study conduct:

  • Start-Up Activities
    • Develop protocol; review protocol and electronic case report forms (eCRFs)
    • Aid in study design in collaboration with external consultants and sponsor
    • Investigator/Key Opinion Leader (KOL) recruitment, communication, and management
    • Review safety monitoring plan and statistical analysis plan to provide insight
    • Site initiation and enrollment issues
  • Ongoing Trial Activities 
    • Available 24/7 
    • Frequent calls to investigators throughout trial
    • Actively works with clinical research associates (CRAs) and project managers on day-to-day patient care and medically relevant study conduct issues
    • Assist sites with inclusion/exclusion criteria questions
    • Assess need for protocol amendments
    • Collaborates with sponsor medical and pharmacovigilance teams 
    • Review of lab reports, safety reports, and protocol deviations
  • Close-out Activities
    • Final Tables, Listings & Figures (TLF) review
    • Development of safety reporting
    • Overview and review of Clinical Study Report (CSR)
    • Strategic evaluation of outcomes with sponsor
    • Recommendations for future studies/development

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