Research Center Profile:
Cardiology/Vascular Diseases
Albert Einstein Healthcare Network's Clinical Trials
Research Program (CTRP) was established to provide the
pharmaceutical, biotechnology and medical device industries with a
single point of contact for all clinical trial research needs and
activities. The CTRP is a full-service provider designed to
effectively facilitate complete clinical trial research studies in
the most scientific, efficient and professional manner
possible.
Please refer to the information below:
Albert Einstein Healthcare Network's Commitment to the
Clinical Trials Research Program
Access to a Systemwide Network of Unlimited Participant
Recruitment Potential
CTRP Services
Features and Benefits of the Einstein Clinical Trials
Research Program
To advance our
program mission and our compelling research
goals, we promote collaborative partnering opportunities with
pharmaceutical, biotechnology and medical device industries.
Our objectives are results-oriented:
To expedite the process of introducing new and improved medical
products and treatments that can enhance the health, quality of
life and clinical efficiency of patient care; and
To conduct clinical trial research, based on outcomes, and
provide statistically accurate and reliable evaluation of
data.
Clinical Trials Program History
The Clinical Trials Research Program (CTRP) of Albert Einstein
Healthcare Network is an outgrowth of a century-long commitment to
clinical trials research, one that began in 1916 in an attempt to
control an outbreak of infantile paralysis.
Today, research is a vital and complementary component of
Einstein's three-tiered mission for providing well-rounded,
quality patient care and education. In fact, 250 active clinical
trials are in progress at Einstein today.
The Clinical Trials Research Program is a highly professional
organization that maintains the personnel, facilities, resources
and expertise necessary to ensure corporate sponsor confidence and
access to a full range of services to meet the demands of a
complete clinical trial research study.
We provide a single point of access to the following
services:
A multidisciplinary faculty of clinical investigators
representing medical and surgical specialties
Access to a large pool of potential research participants
Experienced research study coordinators
Onsite human subjects review committee
Investigational drug services
Biostatistical support
Clinical research management office
Access to a Systemwide Network of Unlimited Subject
Recruitment Potential
With three hospitals housing approximately 1,000 beds, as well
as many outpatient centers and a residential care facility, Albert
Einstein Healthcare Network is one of the Philadelphia region's
most active healthcare networks. Our broad, diverse patient base
affords rapid access to numerous inpatient and outpatient
participants for virtually any type of clinical research
investigation. Albert Einstein Healthcare Network is comprised
of:
Albert Einstein Healthcare Network has more than 250 physicians
on staff, with an additional 700 active, affiliated physicians,
many of whom are involved in academic medicine and conducting
clinical research. The residency and training requirements of
several specialties and subspecialties also require research
training where residents learn and engage in clinical research
programs.
Clinical Research Coordinators
Albert Einstein Healthcare Network has a group of dedicated,
experienced nurses who specialize in conducting clinical trial
research studies. The CTRP office assigns the nurses to specific
protocols as needed. In addition, certain large departments, such
as the Cancer Center, have their own dedicated staff of research
nurses.
With approximately 32,000 inpatient admissions and 455,850
ambulatory visits throughout our network each year, Albert Einstein
Healthcare Network's Clinical Trials Research Program offers
outstanding research opportunities in a wide variety of clinical
settings.
Human Research Review Committee Institutional Review
Board
Albert Einstein Healthcare Network's Institutional Review
Board has a Federal Wide Assurance with the federal Office for
Human Research Protections. The purpose of the IRB is to assure
that all studies conducted at Einstein are conducted according to
the principles for the ethical treatment of research participants
as outlined in The Belmont Report. The IRB is composed of
physicians, research nurses, ethicists and community members. The
IRB reviews protocols according to federal guidelines, assesses the
risks and benefits to the participants for any study and, through
review and approval of the informed consent document, ensures the
participants who agree to participate in studies are provided with
sufficient information to allow them to make an informed consent to
participate. Principal investigators, physicians, research
coordinators and other individuals involved in the design, conduct
and reporting of human participant research are required to receive
appropriate training and to be certified.
Investigational Drug Services
The Department of Pharmacy is dedicated to supporting
investigational drug research at Albert Einstein Healthcare
Network. The department is involved throughout the entire life
cycle of a study at Einstein. From the initial planning for a
study, a pharmacist is required to sign off on each study. A
pharmacist is also a member of the Institutional Review Board.
Pharmacy is involved in issues related to:
Receipt and/or procurement of drugs
Checking for compatibility with other medications
Storage
Dispensing
Maintaining appropriate records, and
Continuing education of possible new products entering the
market
Upon termination of the study, Pharmacy handles close-out issues
that are associated with the trial, such as meeting with clinical
monitors from the sponsor or other companies representing the
sponsor. The services provided are designed to ease the burden on
investigators, coordinators, medical staff and nursing, by handling
drug-related issues and providing a professional service to our
sponsors.
Biostatistical Support Services
The Clinical Trials Research Program has an onsite
Biostatistician who is available to meet the needs of industry in
design of research studies, sample size determination, and data
analysis. Our Biostatistician is also a journal editor who can
critique and edit the statistical methods and result sections of
manuscripts, proposals and industry reports.
Clinical Research Management
At Einstein, Clinical Trials Research Management Operations is
composed of a staff of individuals trained in administrative and
financial aspects of clinical trials. The management of clinical
trials research provides support to investigators by assisting them
in identifying potential studies and by interacting with industry
to develop and negotiate budgets and contracts and to monitor
expenditures. Clinical Trials Research Management is responsible
for the administrative aspects, allowing investigators to focus on
the clinical and scientific aspects of their research
activities.
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.
