Corporate Personnel
Thomas M. Shiovitz, M.D. President

Thomas M. Shiovitz, M.D. is a Board-Certified Psychiatrist who has been a Principal Investigator for over 20 years and is the founder of California Neuroscience Research Medical Group, Inc., a CNS-focused site which specializes in studies of Alzheimer’s Disease, Insomnia, Anxiety, Depression and Migraine. Growing concern about the change in the quality of patients seeking entrance into studies, coupled with the increasing difficulty of pharmaceutical companies to show separation of CNS drugs from placebo, led Dr. Shiovitz to the formation of CTSdatabase, LLC.

Dr. Shiovitz graduated from the University of Michigan Medical School in 1983 and completed his Psychiatric Residency at Cedars-Sinai Medical Center in 1987. Prior to founding California Neuroscience Research and CTSdatabase, Dr. Shiovitz served as President of Investigative Sites for Ingenix Pharmaceutical Services and Medical Director of California Clinical Trials Medical Group. He has been a PI on hundreds of clinical trials and has numerous scientific publications.

Downloads:
Thomas M. Shiovitz's Resume

Adnan Shawkat - Director of Information Systems

Adnan Shawkat is the Director of Information Systems for CTSdatabase where he fulfills the role of lead technologist for the firm. Adnan brings over 14 years of in-depth experience in all stages of the software development lifecycle. Over the past 7 years he has focused his technical expertise specifically in the field of Clinical Data Management to solve complex data problems using database driven web applications. Adnan has managed multiple, large-scale implementations of Electronic Data Capture (EDC) systems such as Medidata Rave and Oracle Clinical. In a Software Architect role he has designed custom applications in the CDM space in accordance with CFR21 Part 11 guidelines. Adnan holds a bachelor’s degree in economics and history from Occidental College and completed his post graduate technical training at the University of California, Irvine in Advanced Database Technologies.

Marlene E. Zarrow, M.Ed. – Operations

As a Certified Clinical Research Coordinator at California Neuroscience Research, Marlene has over 8 years of experience coordinating and rating dozens of clinical trials in Psychiatry and Neurology. She has specialized as a psychometrician and educator in CNS studies and has studied extensively on placebo-response issues in clinical trials.

Marlene provides CTSdatabase training at Investigator’s Meetings and webinars. As a Study Lead, Marlene is the first point of contact for her studies. She is responsible for notifying sponsors and study sites when matches occur and can provide ongoing reports to sponsors.
Marlene brings her research and academic experience to assist in the clinical implementation of CTSdatabase. Ms. Zarrow obtained her Master’s degree in Counseling and Consulting Psychology from Harvard University Graduate School of Education.

Chelsea Steinmetz – Study Lead, Database Associate

A graduate of Rowan University in New Jersey, Chelsea has an interest in research, particularly cognitive psychology. At CTSdatabase, she is a main point of contact for coordinating the site start-up process, site training and user support. Chelsea also provides match notifications and summary duplicate subject reports to sites and Sponsors. Additionally, Chelsea assists the IT Director in the problem-solving lifecycle, performing patch and update testing activities and UAT as necessary.

Sabrina Schoneberg – Site Relations, Database Associate

Sabrina Schoneberg communicates with sites and answers questions regarding database matches for prescreen sites. Sabrina is responsible for troubleshooting CTSdatabase issues and assists the IT Director in testing updated versions of the database. Sabrina reviews database entries to ensure the integrity of the data.

Daniya Chowdhury - Quality Assurance and Compliance

Daniya has 9 years of experience in the field of clinical trials. She has worked as a Clinical Research Coordinator for Psychiatric and Neurological studies, and has experience with EDC study builds and Quality Assurance.

Daniya is responsible for overseeing CTSd quality and privacy. She proactively assures that all processes adhere to established SOPs.

She holds a Master’s degree in Public Health from the University of Southern California in Los Angeles, and Bachelor’s degrees in Biological Sciences and Sociology from University of California in Irvine.


Consultants
Matthew Crowley, Corporate Counsel

Matthew Crowley is a venture lawyer, with a practice focused on assisting entrepreneurs in creating new businesses and achieving their goals for growth. Crowley regularly represents startups, with startup clients representing at least 70% of his practice.
Crowley began his career in San Francisco at the height of the dotcom boom, practicing law with corporate finance groups including Pillsbury Madison & Sutro (now Pillsbury Winthrop) and Morrison & Foerster. After eight years of private practice, Crowley moved into senior management with Evoke Software in 2001, serving as vice president and general counsel. In 2004, Crowley joined the management team at Technicolor Home Entertainment Services in Camarillo, California, a division with revenues of $2 billion annually. In 2006, Crowley established Crowley Corporate Legal Strategy to offer corporate legal services to entrepreneurs looking to start or grow their businesses.

Matt is the President of the Los Angeles Venture Association (LAVA) and an adjunct professor at Loyola Law School.


Michael Fedrick, Esq., Intellectual Property and Patents

Attorney, Loza & Loza, Intellectual Property Solutions Group.
Michael Fedrick is an intellectual property attorney with 20 years of experience securing patent and trademark protection worldwide for clients ranging from start-ups to Fortune 500 companies. He has a strong background supporting entrepreneurs, manufacturers, and service professionals in industries ranging from biotechnology to software.

Michael works with clients in the U.S., Europe and Asia, and is fluent in Mandarin Chinese. A frequent speaker, he lectures on matters involving all aspects of intellectual property law to students and members of the business community. He is a past president and current member of the board of the San Gabriel Valley Bar Association, and has served on committees of the International Trademark Association. He also presently serves on the board of Villa Esperanza, an organization serving the needs of individuals with autism and other developmental disabilities.

Michael previously served as counsel for the biopharmaceutical business of Baxter Healthcare Corporation, where he was responsible for intellectual property matters relating to product lines with sales in excess of $1 billion. While there, he spearheaded the patent and trademark work for a new pharmaceutical product from inception through FDA approval.

Michael graduated from Stanford University with a Bachelor of Science in the Biological Sciences and from the University of California, Los Angeles School of Law. He is registered to practice before the U.S. Patent and Trademark Office and is admitted to the State Bar of California.

Steve R. Mitchell PhD, Biostatistician

Dr. Mitchell has over 20 years of experience as a biostatistician. He is an expert in applied and theoretical statistics in biopharmaceutical manufacturing and clinical trials. Steve has been working for the last 6 years at Amgen, Inc. in Thousand Oaks, CA as the Principal Quality Engineer and Biostatistician.

Past work experience includes Manager of Statistics at Baxter Healthcare and Lead analyst and Statistician for Kaiser Permanente Center for Health Research in Portland. Steve was the Director of Statistics and an Assistant Professor in the Department of Psychiatry at Drew Medical School and UCLA Alcohol Research Center in Los Angeles.

Dr. Mitchell brings a wealth of knowledge and experience in biostatistics to his consulting role for CTSdatabase.

Education:

Ph.D., 1994 University of California, Santa Barbara (Cognitive Psychology & Statistics)

M.A., 1984 San Diego State University, (Experimental Psychology)

B.A., 1980 University of California, San Diego, (Experimental Psychology)


Jeffrey S. Klein, Strategic Advisor

Jeff Klein spent 15 years with the Los Angeles Times and Times Mirror in senior management positions, including senior vice president and general manager, news, and senior vice president for consumer marketing. He also served as president of two large regional editions of the newspaper. For several years, Klein was CEO of California Community Newspapers, Inc., a Times Mirror company.

Klein is one of the few traditional media executives who successfully transitioned to the Internet publishing model. He co-founded 101communications - a B2B multimedia publisher serving the information technology market and served as president and CEO from 2001 to 2006.

Klein began his career as a lawyer, first in the entertainment industry and later on behalf of the Los Angeles Times as a specialist in First Amendment issues. He has taught media law and media business classes at the University of Southern California for many years.

Klein received his master's degree in journalism from Columbia University, his law degree from Stanford University and his bachelor's degree, summa cum laude, from Claremont McKenna College.


Laurie A. Allen

Laurie A. Allen, formerly of counsel, Healthcare Law and Regulatory Affairs.

Ms. Allen represented technology driven companies for 20 years in the areas of corporate, securities, tax and intellectual property. Her primary focus had been in the fields of pharmaceuticals, biotechnology, health care, medical devices and information technologies. Laurie was the initial HIPAA consultant for CTSdatabase.