Research Center Profile:
Axiom Clinical Research of Florida
Axiom Clinical Research of Florida has been successfully
completing Phase II-IV neurology clinical studies in an outpatient
setting since 1993. Our mission statement is simple: "Axiom
performs clinical research that provides exceptional patient care
and efficiently produces high quality, clean and credible research
data." Our research is conducted following FDA and ICH GCP
Guidelines. Under the able leadership of our five prominent Tampa
Neurology physicians, we are able to provide individualized service
to patients and clinical development sponsors in all areas of
neurologic research. We have recently been joined by five (5) Board
Certified Internal Medicine physicians (one of whom is also Board
Certified in Endocrinology), who have been involved as Principal
and Sub Investigators for cardiovascular and Internal Medicine
based protocols since 1996. All our physicians are well-versed in
protocol requirements and conduction of studies according to FDA
and ICH/GCP Guildelines. Our Neurology practice has conducted
trials in:
Alzheimers Disease
ALS
Anxiety Disorders
Chronic Pain
Dementia (including MID & DAT)
Depression
Epilepsy
Head Injury
Migraine/Headache
Multiple Sclerosis (with/without Spasticity)
Muscle Disease
Neuromuscular Disorders
Obesity
Parkinson’s Disease
Peripheral Neuropathy
Sleep Disorders
Stroke
Vascular Dementia
Other Neurological Disorders
Our Internal Medicine/Endocrinology practice has conducted
trials in:
Hypertension
Diabetes
Anti-Infectives
Hyperlipidemia
Neuropathic Pain Control
We have successfully conducted clinical trials under contract
with numerous pharmaceutical companies, including:
Abbott
Amgen
Athena Neurosciences
Bayer Pharmaceuticals
Berlex Labs
Biogen
Boehringer Ingelheim
Bristol Myers Squibb
Cephalon
Eisai America, Inc.
Forest Laboratories
Genentech
Glaxo Wellcome
Jannsen
Marion Merrell Dow
Merck
Neotherapeutics
Novartis
Parke Davis
Regeneron
Sandoz
Scherer DDS
Synergen
Syntex
Wyeth Ayerst
Zeneca
Regulatory Submission Turn-Around Time:
3 Business Day(s) Average Number of Total Patients Enrolled:
8 Average Percent of Total Patients Randomized:
80% EDC Capabilities:
Yes
Axiom Clinical Research of Florida is located within minutes of
Tampa International Airport and three major area hospitals. We are
equipped to perform EMG and NCV studies, evoked potentials, EEG and
ECG on site, and have access to full pulmonary function and
clinical laboratory facilities within our building. A sleep lab and
a MRI Diagnostic Center, both with accredited personnel, are
available for our use at each of our affiliated hospitals. We have
both -20° and -70° freezers, as well as a locked refrigerator and
locked drug cabinets available on site for drug and/or lab sample
storage. We have dedicated space for CRA monitoring, with phone,
fax, and on line service easily accessible for their use.
Axiom Clinical Research of Florida has five neurologists and
five Internal Medicine physicians, all of whom are experienced,
dedicated, and well-versed in clinical trial procedures and
requirements. We also have four clinical trial coordinators, one of
whom is CCRC certified through ACRP, experienced in adhering to
protocol requirements, providing study-specific patient
assessments, and detailed data collection.
AXIOM CLINICAL RESEARCH OF FLORIDA
PHYSICIANS
STEPHEN M. SERGAY, M.D.:
Graduating in 1970 from University of Witwatersrand Medical School
in Johannesburg, South Africa, Dr. Sergay went on to complete his
residency through Harvard University in Boston, Massachusetts from
1973 through 1976, at Peter Bent Brigham, Beth Israel, and
Children’s Hospitals. He received Board Certification in Neurology
& Psychiatry in 1977, becoming a naturalized citizen of the USA
in 1978. In 1981, Dr. Sergay and his family moved to Tampa, FL.
where he founded Tampa Neurology Associates. In 1993, he was one of
the principal founders of Axiom Clinical Research of Florida,
conducting clinical trials for major pharmaceutical companies such
as Merck, Novartis, Parke-Davis, and other well-known sponsors. Dr.
Sergay was chosen as President of the American Academy of Neurology
in 2005 and is a well-known speaker for the industry. He has
staffing privileges at Memorial Hospital of Tampa, St. Joseph’s
Hospital, St. Joseph’s Women’s Hospital, and Tampa General.
SUSAN J. STEEN, M.D.:
Dr. Steen graduated from the University of Florida Medical School
in 1978, served her residency in University of South Florida and
affiliated hospitals and completed her Neurology residency at the
University of Florida, Gainesville, receiving Board Certification n
Medicine & Surgery in 1979 and in Neurology and Psychiatry in
1991. She joined Dr. Sergay as a neurologist in Tampa Neurology
Associates in 1983, becoming a partner shortly thereafter, and is a
co-founder of Axiom Clinical Research of Florida (1993). Dr. Steen
is a renowned speaker for Alzheimer’s Disease, and is Medical
Director of the Memory Disorder Clinic at the Center for
Comprehensive Rehabilitation at Memorial Hospital. She is on staff
at St. Joseph’s, Memorial Hospital of Tampa, St. Joseph’s Women’s
Hospital and Tampa General.
MARK C. CASCIONE, M.D.:
Dr. Cascione received his Doctorate in Medicine in 1991 from
University of Vermont College of Medicine. After completing
residencies at Maine Medical Center, Portland, Maine (1992) and
Duke University Medical Center, Durham, North Carolina (1995), he
received his Board Certification in Neurology & Psychiatry in
1997 and in Electrodiagnostic Medicine in 1998. Dr. Cascione joined
Tampa Neurology Associates and Axiom Clinical Research of Florida
in 1996, subsequently becoming a partner in both companies. He is
on staff at St. Joseph’s, Memorial Hospital of Tampa, St. Joseph’s
Women’s Hospital and Tampa General. Dr. Cascione is a well-known
speaker for the Multiple Sclerosis Foundation and is Medical
Director of the Multiple Sclerosis Clinic at the Center for
Comprehensive Rehabilitation at Memorial Hospital.
SUNIL S. REDDY, M.D.:
Dr. Reddy graduated from Gandhi Medical College in Hyderabad, AP,
India, in 1998, as well as receiving his ECFMG Certification that
same year. He completed his Neurology residency and Clinical
Neurophysiology Fellowship at Allegheny General Hospital,
Pittsburgh, Pennsylvania in 2004 and 2005. Dr. Reddy received his
Diplomate, American Board of Psychiatry & Neurology
certification in 2005 and his Diplomate, American Academy of
Electrodiagnostic Medicine certification in 2006. He joined our
staff at Axiom Clinical Research of Florida in August, 2006 after
working as a neurologist in Pennsylvania and North Dakota. Dr.
Reddy is well-versed in ICH/GCP procedures and in all aspects of
clinical research practice.
INSTITUTIONAL REVIEW BOARD
For inpatient studies, we utilize St. Joseph’s, and Memorial
Hospitals IRBs. For outpatient studies, we are able to use either a
Central IRB designated by the Sponsor, or one of our local IRBs, if
needed.
CURRENTLY ENROLLING TRIALS
Axiom Clinical Research is currently enrolling for studies in
the following areas. If you'd like to participate in any of
these trials, please contact our office for further
information>
Alzheimer's Disease
Migraines
Multiple Sclerosis
M S with Cognitive Impairment
MS with Spascity
CONTACT INFORMATION
For more information on our site’s abilities and interests,
please refer to the contact information below.
Do You Have MS?
Patients needed for Primary Progressive and Relapsing Remitting MS studies
If you are interested in contacting this center to discuss placing a clinical
trial there, please complete and send the email form below. A representative from
the research center will then follow up with you.