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 are imperative to site and subject recruitment.

    Providing insight into clinical practice at all phases of study conduct

    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.

    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
    William Aronstein, PhD, MD, FACP – Vice President, Medical Affairs

    - Dr. Aronstein received his Doctor of Medicine at The Johns Hopkins University

    - He received his PhD from the Dept. of Pharmacology & Experimental Therapeutics at John Hopkins University

    - Completed his residency at the John Hopkins Hospital, Osler Medical Service

    - Extensive experience in Internal Medicine, Drug Development, FDA / EMA briefing documents, PK/PD studies and development of early-stage products

    - Expert in early rare disease and gene & cell therapy programs

    - Held diverse positions at Procter & Gamble Pharmaceuticals

    - Previous Assistant Professor of Medicine, Clinical Director of the Division of Internal Medicine and Clinical Director of Ambulatory in the Department of Medicine at the Johns Hopkins University

    Robert Gordon, MD, FACS – Senior Medical Director

    - Dr. Gordon received his Doctor of Medicine from Cornell University College of Medicine

    - Both Research and Clinical Fellow of Surgery at Massachusetts General Hospital and Harvard Medical School

    - Visiting Scientist under Director Sir Peter Medawar at Transplantation Biology Section Division of Surgical Sciences Clinical Research Centre in Harrow, England

    - Transplant Surgeon with over 30 years of industry and research experience working with immunosuppressants, antivirals and immunocompromised subject populations

    - Served as Medical Director at Roche Laboratories for the Transplant Medicine Division and LifeCycle Pharma

    James P. Maynard, MD, FAASM – Senior Medical Director

    - Dr. Maynard received his Doctor of Medicine from the Medical College of Wisconsin and Medical Internship and Neurology Residency from the Medical College Wisconsin Affiliated Hospitals

    - He served in the US Navy where he was awarded the Navy Achievement Medal from the Secretary of the Navy.

    - Experienced clinical researcher having served as investigator on more than 200 phase 1-3 studies

    - American Board of Psychiatry and Neurology: Neurology and Sleep Medicine

    - American Board of Sleep Medicine: Sleep Medicine

    - Lead Physician of our Clinical Research Center (CRC)

    Elias J Anaissie, MD – Medical Director

    - Doctor of Medicine, University of Paris XII, Faculty of Medicine, Paris, France and Saint Joseph University Medical School, Beirut, Lebanon

    - Fellowship in Infectious Diseases at the University of Texas, MD Anderson Cancer Center, Houston, TX and a Fellowship in Hematology-Oncology, American University of Beirut Medical Center, Beirut, Lebanon

    - Professor of Medicine, The John and Gladys Strauss Chair in Cancer Research, Director, the U. of Cincinnati (UC) Program in Hematological Malignancies and Bone Marrow Transplantation, U. Cincinnati, OH

    - Professor of Medicine and Deputy-Chair, The Myeloma Institute for Research and Therapy, the University of Arkansas for Medical Sciences (UAMS), Little Rock, AR

    - Associate-Professor of Medicine, U. of TX, MD Anderson Cancer Center, Houston, TX

    Robert S Gaston, MD – Medical Director

    - Dr. Gaston received his Doctor of Medicine at the St. Louis University School of Medicine.

    - He completed his Residency, Fellowship and Internship in Internal Medicine and Nephrology at the University Hospital in Little Rock, Arkansas

    - Completed his Fellowship in Renal Transplantation at the University of Alabama at Birmingham

    - Professor Emeritus of Medicine and Surgery – Univ. Alabama at Birmingham

    - Director, Comprehensive Transplant Institute

    - Has trained thousands of nephrologists that now practice around the globe

    - Medical Director, Kidney and Pancreas Transplantation

    - Robert G. Luke Endowed Chair in Transplant Nephrology

    - 2018 AST Lifetime Achievement Award Recipient

    Achim Nutzenberger, PhD, MD – Medical Director (EU)

    - Dr. Nutzenberger earned his MD by studying at the University of Bochum in Germany; the University of Ulm, Germany; Technical University of Munich, Germany; and, Harvard University of Boston

    - He received his PhD at the Institute of Anatomy at the Ludwig-Maximilians-University of Munich.

    - In addition, Achim earned his MBA in Economics and Business Administration from the University of St. Gallen in Switzerland.

    - He achieved his Specialization Board Exam in Ophthalmology through the Medical Board of Hessen in Frankfurt, Germany.

    - Therapeutic Experience in Urology, Solid Organ Transplantation, Bone Marrow/Stem Cell Transplantation, Immunology, Immunotherapy and Nephrology

    - For many years he served as lead for Fresenius' global transplant unit and afterwards for Fresenius Medical Care's Clinical Research Services in ROW as well as a management member for Fresenius' dialysis clinics in EMEA and LA

    Rodrigo A. Athanazio, PhD, MD – Medical Director (Brazil)

    - Formation: Graduation at the Federal University of Bahia. Fellowship in Internal Medicine at the Federal University of São Paulo and Pulmonology at Hospital das Clínicas - USP. 

    - PhD in Pulmonology – University of São Paulo, Brazil

    - Areas of interest: Asthma, bronchiectasis, cystic fibrosis, lung infections, COPD (emphysema and chronic bronchitis), and pulmonary embolism.