Overview

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.

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.

The CTRP 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.

Research Experience

The CTRP 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;
• On-site human subjects review committee;
• Investigational drug services;
• Biostatistical support; and
• Clinical research management office.

Facility Description

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:

• Einstein Medical Center - Philadelphia, a tertiary care teaching hospital;
• Einstein Medical Center - Montgomery includes advanced medical and surgical care, diagnostic testing services, a neonatal intensive care unit and 24-hour emergency care;
• Einstein Medical Center - Elkins Park offers a full range of services, including a 24-hour emergency department on a 30-acre suburban campus in Montgomery County;
• Einstein Center One offers easy access to primary care and specialty doctors to people living in Northeast Philadelphia and Lower Bucks and Montgomery Counties;
• Germantown Community Health Services, providing primary, ambulatory and emergency care to the Northwest Philadelphia community;
• Moss Rehab, a nationally recognized medical rehabilitation facility with inpatient and outpatient services; and
• Willowcrest, a center for subacute care.

Investigator Experience

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.

Staff Experience

Clinical Research Coordinators – Albert Einstein Healthcare Network has a group of dedicated, experienced nurses who specialize in conducting clinical trial research studies.

Patient DEmographics

With approximately 32,000 inpatient admissions and 455,850 ambulatory visits throughout our network each year, the CTRP offers outstanding research opportunities in a wide variety of clinical settings.

Other Information

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 lifecycle of a study at Einstein. From the initial planning for a study, a pharmacist is required to sign off on each study. 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, the department 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 CTRP has an on-site 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.