Vision Clinical Research is a subsidiary of Vision Biotechnology Consulting (VBC). Since 1996, VBC has guided biotech and pharmaceutical companies to more than 100 successful regulatory approvals, clearances, or CLIA waivers in the United States and multiple CE Mark certifications or marketing authorization application (MAA) approvals in foreign countries. More recently, Vision Clinical Research (VCR) has brought together the talents of VBC Founder Mark Sarno and long-term collaborators and scientific colleagues to provide contract research organization (CRO) services to existing and new clients. The VCR staff has designed, managed, monitored, analyzed, and reported medical device studies up to several thousand patients and Phase I-IV drug studies in multiple clinical areas. With specific regard to laboratory-developed tests (LDTs), VCR has recently designed, managed, monitored, analyzed, and reported multiple method validation studies ranging from a single site study of 100 patients up to a 40-site longitudinal study of 1250 patients. As such, VBC and VCR present clients with a pedigree of success in IVD, medical device, and pharmaceutical development.
- Clinical study design and powering
- Case Report Form generation
- Institutional Review Board/Ethics Committee
- Study management
- GCP compliance
- Query resolution
- Clinical study report generation
- Reference lab testing
- Protocol generation
- Informed Consent documentation
- Site training and initiation
- Study monitoring
- Database generation and data entry
- Biostatistical analysis
- Quality assurance
- Analytical performance studies
|Title||Services||Years experience in scientific and clinical research|
|Mark J. Sarno, eJD||President, Project Manager, Clinical Scientist, Biostatistician||Project management; protocol and associated document generation; biostatistical analysis; clinical study report generation||34|
|Erika Ammirati, RAC, MT (ASCP)||Regulatory Scientist, Clinical Scientist, Project Manager||FDA pre-and post filing interactions; protocol development with associated documents; clinical site screening, initiation, monitoring, and close-out; clinical study report generation||31|
|Daniel Hogan, PhD||Clinical Scientist, Project Manager||Project management; protocol and associated document generation; CRF and ICF generation; clinical study report generation||42|
|Michael J. Lichtman, BS||Project Manager, Lead Clinical Research Associate||Site screening; site research agreements; site training; site monitoring; data entry; query generation and resolution||22|
|Erich Blase, BA||Clinical Research Associate||Generation of protocols, CRFs, ICFs, clinical study reports, and associated documentation; site selection, training, and monitoring; data entry; data analysis, query generation and resolution||41|
|Diane Hogan, BA||Clinical Research Associate||Study materials generation and reproduction; site screening; site research agreements; site training; site monitoring; database development; data entry; query generation and resolution||21|
|Christine Kavanaugh, BHS, MT (ASCP)||Clinical Research Associate||Study start-up, site qualification and initiation, monitoring, close-out||21|
|Laura Sarno, BS||Clinical Scientist, Data Manager||Database design, data management, data entry, query generation and resolution||38|
Mark J. Sarno, eJD has over 34 years experience in research, development, clinical/regulatory, biostatistics, and project management within the pharmaceutical, in vitro diagnostics, and medical device fields. He has developed products covering such diverse clinical areas as oncology, cardiovascular disease, diabetes, infectious disease, metabolic bone disease, rheumatology, fetal aneuploidies, newborn screening, thrombophilia, asthma, and gastroenterology. He is a patented inventor and member of the United States Patent Bar and an associate member of the California State Bar. He founded Vision Biotechnology Consulting, which has for 21 years assisted companies in design, development, clinical research, and regulatory affairs resulting in 45 FDA clearances and approvals. He was also previously Director of Product Development, at NovaDx Inc., which developed the first specific in vitro diagnostic test for rheumatoid arthritis and osteoarthritis. As a biostatistician, Dr. Sarno has analyzed some of the seminal epidemiological studies in cardiovascular disease including the Atherosclerosis Risk in Communities (ARIC) study as well as international oncology studies such as REDUCE. He has published in many prestigious journals such as Journal of Urology, Urology, Diabetes Care, Food and Drug Law, Journal of the American College of Cardiology, Journal of Clinical Pharmacology, Clinical Chemistry, Clinical Biochemistry, Prostate Cancer and Prostatic Disease, Gynecologic Oncology, Fertility and Sterility, and Cancer Research. He also currently serves as Scientific Advisory Board Member to manufacturers of diagnostic tests. In his occasional spare time, Dr. Sarno enjoys running, flying airplanes, riding motorcycles, rescuing German Shepherds, and playing drums.
Erika B. Ammirati, RAC, MT (ASCP) is an independent regulatory consultant to industry located in Los Altos, CA. Ms. Ammirati specializes in the areas of clinical trials and product approvals for diagnostics and devices, with an emphasis on point-of-care (POC) and over-the-counter diagnostics. She is also well-versed in CLIA regulations and has brought several POC diagnostics through the CLIA waiver process. Prior to becoming a consultant 23 years ago, Ms. Ammirati gained over 10 years industry experience in in-vitro diagnostic (IVD) firms, preceded by a 10-year career in the clinical laboratory as a medical technologist. Ms. Ammirati is a past Industry Representative on two FDA Advisory Panels is the author or co-author of numerous publications; she holds a BS degree in Genetics from the University of California, Davis, and current California State licensure in Medical Technology. She is also certified as a regulatory professional through RAPS (Regulatory Affairs Professional Society).
Daniel L. Hogan, PhD received a Bachelor of Arts in Biological Sciences from California State University Northridge, and a Doctorate in Medical Science from Odense University, Denmark. He received clinical research training in the Departments of Gastroenterology, University of California Los Angeles, and University of California San Diego. He held a UCSD academic appointment (Research Specialist) training professionals and paraprofessionals in clinical research techniques with emphasis in Gastroenterology. He also conducted basic research evaluating proximal gut absorption/secretion. He was founder & President of Clinical Applications Laboratories, Inc. San Diego, CA. Dan directed and conducted clinical research Phase 1 – 4 protocols, with experience in over 100 clinical trials. He formulated protocols, operations manuals, informed consent forms, and authored clinical study reports. He trained and supervised clinical research coordinators, CRAs and monitors, and consulted with national and international pharmaceutical companies. Dan has published over 150 papers, book chapters and abstracts in peer-reviewed medical journals including scientific findings from clinical research protocols approved by Investigational Review Boards.
Michael Lichtman, B.S., is a Clinical Research Associate located in Carlsbad, CA. Mr. Lichtman specializes in providing comprehensive clinical monitoring and site management of trials. He has worked in the clinical arena for 22 years and is experienced in all four pharmaceutical phases, and in vitro diagnostic trials. In addition to extensive site monitoring (from qualification to termination), he is well versed in protocol/CRF design; site regulatory compliance; investigator selection; and database design/entry/verification. Mr. Lichtman holds a BS Degree in Biology from California State University, San Marcos. In his free time, this Marine Corp Veteran enjoys flying, running, and surfing. He serves on the Board of Directors for a local environmental 501(c)(3) non-profit, and is a volunteer wildlife rescuer.
Erich Blase, B.A., is a Clinical Research Associate located in San Diego, CA. Mr. Blase specializes in providing comprehensive clinical monitoring and site management of trials. A graduate of the biology program at the University of California, San Diego, he has worked in the clinical arena for 19 years. During his career at Amylin Pharmaceuticals, he acquired experience in pharmaceutical phases 1 through 4, with a focus on Phase 1 and 2 trials. He has also had experience with in vitro diagnostic trials while contracting at Gen-Probe. In addition to extensive site monitoring (from qualification to termination), he is well versed in protocol/CRF design; site regulatory compliance; and database design/entry/verification. He has published more than 15 papers, and has made several presentations at scientific conferences. In his free time, Erich enjoys playing music and surfing. He also runs, but is hard-pressed to say he enjoys it.
Christine Kavanaugh, BHS, MT (ASCP) is a Clinical Research Associate located in Lexington, KY. Ms. Kavanaugh has 21 years’ experience in clinical research encompassing numerous therapeutic areas including complex protocols in neurology and oncology. She has worked in all phases of research trials involving all manner of investigational products, i.e. drugs, biologics, devices, and diagnostics. She has experience on global trials with critical care /inpatient /outpatient populations, adult and pediatric, and orphan diseases. Ms. Kavanaugh is familiar with all phases of the study life-cycle: study start-up, site qualification and initiation, monitoring (on-site and remote), and study close-out. Ms. Kavanaugh has also performed site auditing and is well versed in ICH/GCP guidelines. Ms. Kavanaugh earned her Bachelor of Health Sciences degree in Medical Technology from the University of Kentucky. Prior to entering the research arena Ms. Kavanaugh worked in a hospital clinical laboratory for 12 years, holding supervisory positions in Chemistry and Hematology, as well as serving as the hospital Safety and Chemical Hygiene Officer.
Diane L. Crombie Hogan holds a B.A. in Animal Physiology from the University of California, San Diego. She was a Research Associate in the Department of Medicine University of California, San Diego performing bile acid metabolism studies in both animal and human models for several years before being recruited into industry. Subsequently she worked and then consulted for a number of biotechnology/pharmaceutical companies including Ligand Pharmaceuticals, Conforma Therapeutics and X-Ceptor Therapeutics utilizing various models to examine chemical compounds in metabolic diseases as well as cancer indications. During this time she performed extensive data analysis and presentation preparation. Most recently, Diane was a consultant and Clinical Research Monitor with Clinical Applications Laboratories Inc. San Diego, CA where she monitored clinical research protocols, regulatory documents, CRFs and source documentation. She has ppublished over 45 papers, book chapters and abstracts in peer-reviewed medical journals including scientific findings from clinical research protocols approved by Investigational Review Boards.
Laura Sarno, BS has 38 years of experience as a research scientist, product development scientist, clinical scientist, regulatory affairs professional, project manager/director, and data management director. She has worked extensively in multiple clinical fields including breast and prostate cancer, general urology, dermatology/dermatologic surgery, Alzheimer’s disease, metabolic bone disease, and infectious diseases. She currently directs the data management function within Vision Clinical Research for all ongoing studies.