The Institute for Clinical Research at Holy Name Medical Center provides exceptional investigators, facilities, and services for sponsoring agencies that seek to advance patient care through superior clinical research. We're dedicated to conducting expeditious, high-quality clinical trials to test new medications, devices, diagnostic modalities and treatment protocols.

Holy Name Medical Center is a dynamic health care institution that has received many honors of distinction for our treatment innovations, compassionate patient care, and quest for scientific breakthroughs. Our state-of-the-art facilities exceed the highest standards for carrying out today's most promising clinical research. We provide sponsors with research support throughout all the stages of their clinical trials.

The Institute for Clinical Research at Holy Name Medical Center is a vibrant, full-service center that provides a core facility and infrastructure dedicated to conducting all types of clinical research (both drug and device). Because of our size and scope, we can offer sponsors high-quality data and accruals more expeditiously and efficiently than academic clinical research centers.

The Institute for Clinical Research provides a single point of contact for budgets, contracts, and regulatory and patient recruitment issues. We ensure efficiency with each study through the centralized processing of all aspects of clinical trials, including identifying diligent, well-trained investigators; recruiting, enrolling, and retaining study subjects; planning protocol strategies; and preparing and submitting regulatory documents.

We maintain a database of active and potential investigators, and we can match your needs with an appropriate physician(s). We utilize a swift investigator selection and enrollment process. We have a large electronic patient database from which we can enroll an adequate number of study patients to meet your needs. We accomplish this with database searches, central advertisements, and screening.

The Institute for Clinical Research is headed by a research director with extensive experience in administration and clinical research. The research team also includes a medical director, several certified clinical research coordinators, administrators, and support staff. The team is dedicated to meeting sponsors' expectations and to fulfilling the research needs of investigators, patients, and sponsoring agencies.

The medical staff of Holy Name Medical Center comprises several hundred board-certified physicians in all the major medical and surgical specialties. Our investigators have vast experience in conducting government and industry-sponsored research. The Medical Center also employs highly skilled advanced practice nurses, registered nurses, licensed technologists in all fields, dedicated ancillary and support staffs, and an administration that is committed to advancing medical and scientific knowledge.

The Institute for Clinical Research is currently conducting both inpatient and outpatient phase II-IV studies in multiple therapeutic areas, and in 2006 will be opening a state-of-the-art phase I study facility. We provide sponsors with the following services:

• identification of qualified investigators
• experienced clinical research recruiters and coordinators
• central Institutional Review Board (Western IRB) submissions and correspondence
• preparation and negotiation of itemized study budgets
• clinical trials agreement negotiation and execution facilitated through master clinical trials agreements
• expeditious subject selection, accruals, and enrollments
• centralized processing of all aspects of clinical trials, including planning studies, designing protocols, identifying investigators, and developing regulatory documents
• high-quality data that is tracked, entered, and validated using industry standards
• clinical, laboratory, and clerical support staff
• on-site quality assurance program and good clinical practices auditing
• performance tracking
• in-depth discussions with sponsors
• comprehensive standard operating procedures (SOP) to ensure consistent and appropriate practices
• study tracker software to track multiple sites and multiple study enrollment status

The Institute for Clinical Research's state-of-the-art research facility meets regulatory and industry standards. Our facility includes a waiting area for study patients, patient examination rooms, investigator's office, a laboratory area, a conference room, private rooms for monitors, space for administrators and coordinators, and storage space for regulatory documents and study records. Our drug/device storage area was specially built to meet FDA requirements, industry standards, and regulatory guidelines.