Research at Geisinger spans multiple disciplines. In addition to the Center for Clinical Studies, Geisinger research also includes the Sigfried and Janet Weis Center for Research and the Geisinger Center for Health Research. These centers are home to internationally renowned investigators with expertise in epidemiology, molecular and cellular biology, rural health, genomics, healthcare information technology, development of new healthcare models and clinical trials management.
Research in clinical divisions addresses disease-specific initiatives and provides sites for clinical trials. Major research initiatives include genomic medicine, development of new models of care, epidemiological and effectiveness studies, e-initiatives, and clinical trials.
Geisinger’s two nascent institutes, Geisinger’s Genomic Medicine Institute and the Geisinger Obesity Institute, also provide support for interdisciplinary investigations and specific research efforts. Investigators in the Genomics Medicine Research Program are supported by Geisinger’s Genomics Core which includes a repository of blood samples currently including more than 20,000 consented patients.
Additionally, CCS investigators may also utilize a number of specific Geisinger resources that are of particular advantage to the conduct of clinical trials. These include Geisinger’s Electronic Health Record, Survey Research Unit, Medical Laboratories and Geisinger’s Investigational Drug Service.
Electronic Health Record
The Electronic Health Record permits the use of a study’s specific exclusion/inclusion criteria to screen large or small sections of the Geisinger patient population. The electronic health record, known as Epic®, is CFR 21 Part 11 compliant and can be used for:
- Study feasibility
- As a tool for searching eligibility criteria
- Source documentation, or, for example a repository for notes, labs, radiology, and procedures
- And as a provider connection, or a common means by which providers can access health information
Geisinger also uses Study Manager® clinical trials software to track study opportunity, start-up, process and to track study patients. The software is also used to manage study finances and administrative reporting.
Survey Research Unit
Geisinger’s Survey Research Unit provides research support for the design, authoring, implementation, administration and analysis of surveys. Using computer-assisted telephone and personal interviewing, the unit is fully equipped to contact eligible patient participants by mail, email, phone, or by person.
Geisinger clinical facilities include comprehensive labs that are staffed around the clock, seven days a week, and include dangerous goods or IATA-trained shippers and handlers. Geisinger’s labs are equipped with a -20° freezer as well as a -70° freezer (both of which are temperature monitored), as well as a room-temperature and refrigerated centrifuge.
Geisinger’s Investigational Drug Service
Geisinger’s Investigational Drug Service (IDS) Pharmacy ensures safe and efficient conduct of clinical drug trials. The IDS is a part of the Department of System Therapeutics and acts in compliance with applicable federal, state, and Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requirements regarding investigational drug control.
Inventory Control - The IDS pharmacy orders and receives shipments of investigational drugs. It also maintains appropriate inventory levels to ensure adequate and ready availability of study drug.
Storage - Investigational drugs are stored in the IDS Pharmacy, Knapper Oncology Pharmacy, Geisinger Wyoming Valley (GWV) Pharmacy, and GWV Oncology Pharmacy to ensure appropriate access, security, stability, and compliance with Food and Drug Administration (FDA) guidelines. The IDS Pharmacy currently operates one refrigerator at each location. Units are checked and temperatures are documented for accuracy.
Accountability - The IDS Pharmacy maintains computerized drug accountability records for all study drugs received, stored and dispensed. Study drugs are inventoried daily (when drugs are dispensed) and at least quarterly for quality assurance purposes.
Storage of Records - The IDS Pharmacy maintains drug accountability records on-site for two years and off-site indefinitely.
Packaging and Labeling - The IDS repackages medication in a manner to ensure proper compliance with applicable regulations and any blinding requirements. Inpatient and outpatient labels bear a patient-specific label and meet all labeling requirements of the state board of pharmacy and the FDA (including the legend "For Investigational Use Only" on investigational drug package labels). The IDS Pharmacy utilizes a computerized dispensing system to generate labels and maintain patient profiles and accountability records.