Geisinger Site CV

Geisinger provides extensive value to its sponsors.

General Information

Clinical Research Resources (CRR)	Clinical Research Resources includes five research cores at Geisinger: Office of Clinical Research Operations (OCRO) Investigator Initiated Research Operations Biostatistics Core Phonemic analytics & Clinical data Core Survey Research and Recruitment Core
Audits and Inspections	No 483 warning letters issued from three FDA audits over the past 10 years
OCRO SOPs and Best Practices	SOPs available upon request
Staff	More than a decade of experience managing trials in multiple therapeutic areas-cardiovascular, pulmonary, gastroenterology, endocrine, OB/GYN, palliative care, critical care, laboratory medicine, general internal medicine. More than 90% of Clinical Research Coordinators (CRC) are RNs All CRC’s and Project Managers are required to be SOCRA and/or ACRP certified. All study staff and investigators are required to complete and maintain Basic Human Subjects, Responsible Conduct for Research and Good Clinical Practice training through the Collaborative Institutional Training Initiative (CITI)
Study Monitors	Wireless Internet available CRO & Sponsor Monitors are provided with laptop and access to subjects’ EMR; 2 weeks advance notice needed for access approval Space provided for monitoring visits Remote monitoring access available with provisions
Different Types of Sponsor Experience/Funding Sources	Industry NIH, NIDDK, NHLBI, Foundations Investigator Initiated
Trial Phase Capabilities	II, III, IV
Miscellaneous	Epic: EMR 21 CFR Part II compliant Dedicated computers for each staff member High speed internet access Internet browser–Internet Explorer Version 11.0 Prompt reporting of inpatient hospitalization SAEs through a unique process which alerts study staff to participants’ in-system hospitalizations on a daily basis
Long Term Storage	GSS Storage Facility 400 Railroad St., Danville, PA 17821

Recruitment

Mature Electronic Medical Records	Contains information on > 4 million unique patients. Records provide real time and historical data useful in pre-identifying potentially eligible study patients. Allows access for provider referrals in multiple therapeutic areas.
Large Trial Recruitment Process	Using the Electronic Medical Record (EMR), data pulls specific to study inclusion/exclusion criteria are programmed primarily by ICD and procedure codes. Identified eligible patients are invited to learn more about the study. Potential patients are listed on a study tracker and contacted by staff. Our process has shown to deliver high enrollment rates, realistic enrollment expectations and low screen failure rates.
Dedicated Research Data & Recruitment Manager	Oversees implementation of trial recruitment strategies and enrollment optimization. Facilitates management of data requests, externally and internally
Excellent Retention Rates	The experience and dedication of OCRO staff, convenient patient tools and a low out-migration rate results in excellent retention rates that are well above average. OCRO has a 10+ year history of conducting 3-5 year outcomes trials with excellent retention rates over 95%
MyGeisinger.org	MyGeisinger.org - A patient web-based portal that provides a convenient way for patients to access their medical record, contact providers/study staff and manage their health. MyChart Mobile - This app provides a MyGeisinger user with secure access to features such as messaging providers, viewing your own and family medical records, upcoming and past appointments, test results, etc. These tools are helpful with both recruitment and retention of study patients.

Regulatory Information

Local Institutional Review Board (Geisinger IRB - GIRB) Phone: 570-271-8663 Fax: 570-214-7031	Full Board review occurs twice monthly. Submission deadline for board review required approximately 3 weeks prior to meeting date. Exempt and Expedited submissions take approximately 2-3 weeks for review and approval. Full Board submissions typically take 1-2 months from submission to approval. GIRB uses iRIS, an electronic document platform for all submissions and tracking The IRB consists of 11 members, 2 co-chairs, 2 ex-officio members, plus 12 alternates. GIRB is fully accredited by AAHRPP
HHS Federal-wide Assurance Protection for Human Subjects	Number: FWA00000063 Expires 17SEP2027
Regulatory and IRB Support	One Sr. CRC and a Project Coordinator dedicated to supporting regulatory tasks for the group. IRB submissions, amendments, communications and tracking completed centrally for GHS OCRO through this central support service
IRB Fees	A one-time fee will be charged for IRB review of all externally-funded research studies. The IRB fee covers initial review and all continuing reviews, amendments and unanticipated problems submitted to the IRB for the life of the study.

Contracts/Budget

Centralized team responsible for CDA’s, agreements, contract & budget negotiation at all Geisinger sites.
Average timeline for contract execution: 3-4 months
Current overhead and applicable fees will apply as appropriate
Contracting Entity: Geisinger Clinic (for all Geisinger sites)

Payee & Address:
Geisinger Clinic
Attn: Research Finance, MC 30-69
100 N. Academy Avenue
Danville, PA 17822-3069 researchach@geisinger.edu

Point of Contact:
Candice Laubach, MBA, CRCP (or designee assigned)
Sr. Director, Research Administration and Strategic Initiatives
Geisinger Clinic
100 N. Academy Ave
Danville, PA 17822-4400
researchcontracts@geisinger.edu
Phone: 570-214-5067

Geisinger Medical Center, Danville PA

Address	100 North Academy Avenue Danville, PA 17822-4400
Office of Clinical Research Operations	Phone: 570-214-1186 Fax: 570-271-6944
Type of Institution	Academic Medical Center and Outpatient Specialty Clinics
Number of Beds North Central Region	560 beds at Geisinger Medical Center (GMC) 72 beds at Geisinger Bloomsburg Hospital 55 beds at Geisinger Shamokin Area Hospital 123 beds at Geisinger Lewistown 311 beds at Holy Spirit Hospital
Research Staffing	18 Clinical Research Coordinators 14 Registered Nurses 4 Cardiovascular Research Coordinators 7 Research Assistants 6 Project Managers 2 Project Coordinators
Investigational Pharmacy	Contact: Adam Gross, PharmD, CCRP Coordinator – Investigational Drug Service Enterprise Pharmacy 100 Academy Avenue Danville, PA 17822-4201 Services & Equipment Drug procurement, preparation & labeling Secure, monitored storage Accountability (Vestigo) Storage room and refrigerator equipped with the TempTrak 24-hour monitoring and alarm system. Traceable to NIST standards. Monthly digital temperature records accessible to study staff/sponsors Refrigerator connected to the hospital’s back-up generator system Disposal of study drug; incineration at off-campus sites
Local Laboratory	Contact: Mike Weaver Analytical Specialist Referred Lab Testing Referred Testing Staff all IATA Certified CLIA and CAP certificates available Services & Equipment Manages collection and processing of research samples (blood or tissue) Packaging and shipment of samples outside of Geisinger Research sample storage, refrigerated or frozen Freezers and refrigerators used to store samples equipped with electronic TempTrak 24-hour monitoring and alarm system. Monthly temperature records accessible to study staff/sponsors Refrigerators/freezers connected to the hospital’s back-up generator system Equipment calibration/validation completed annually with records accessible to study staff -20 and -70 degree C freezers
On site in-patient and out-patient facilities and equipment	ECG machines, scales, blood pressure cuffs and sphygmomanometers, otoscopes. DEXA, X-ray, MRI, CT, echo, etc. All equipment calibrated every 6 months

Geisinger Wyoming Valley Medical Center

Address	1000 East Mountain Boulevard Wilkes-Barre, PA 18711
Research Office Phone Number	Phone: 570-808-1001
Type of Institution	Academic Medical Center and Outpatient Specialty Clinics
Number of Beds	274
Research Staffing	7 Clinical Research Coordinators 6 Registered Nurses 1 Cardiovascular Research Coordinator 1 Project Manager 2 Project Coordinators 1 Research Assistant
Investigational Pharmacy	Contact: Karla Fleury, R.Ph Clinical Pharmacist Phone: 570-808-7704 Services & Equipment Same as Geisinger Medical Center above
Local Laboratory (Hospital Based)	Contact: Johnna Stepanek Research Lab Assistant Phone: 570-808-6091 Fax: 570-808-6090 Services & Equipment Same as Geisinger Medical Center above
On-site in-patient and out-patient facilities and equipment	ECG machines, scales, blood pressure cuffs and sphygmomanometers, otoscopes. DEXA, X-ray, MRI, CT, echo, etc. All equipment calibrated every 6 months

Gray's Woods

Address	132 Abigail Lane Port Matilda, PA 16870
Clinical Research Resources	Phone: 570-214-1186
Type of Institution	Outpatient Specialty Clinics
Research Staffing	2 Clinical Research Coordinators 2 Full-time Registered Nurses 1 Research Assistant
Investigational Pharmacy	Pharmacy is centrally managed by Investigational Drug Services in Danville, PA Contact: Adam Gross, PharmD, CCRP Coordinator – Investigational Drug Service Enterprise Pharmacy
Local Laboratory	Contacts: Kris Carr Medical Technologist II Grays Woods Laboratory Mike Weaver Analytical Specialist Referred Lab Testing Referred Testing Staff all IATA Certified CLIA and CAP certificates available Services & Equipment: Manages collection and processing of research samples (blood or tissue) Packaging and shipment of samples outside of Geisinger Refrigerated research sample storage available Temperatures in freezers and refrigerators used to store samples are monitored daily Monthly temperature records accessible to study staff/sponsors Refrigerators/freezers connected to the clinic’s back-up generator system Equipment calibration/validation completed annually with records accessible to study staff -30 degree C freezer at Grays Woods, and -20 and -70 degree C freezers available at Danville site (samples shipped via GHS courier daily)