Our Commitment to Excellence
At St. Luke’s, we are committed to delivering excellence in every stage of the clinical research process. As a leading healthcare institution offering clinical trials to the communities we serve, we have the infrastructure, expertise, and dedication to ensure the success of your study.
The Clinical Trials Office (CTO) provides comprehensive, centralized support services to ensure each step of every study adheres to all applicable Federal, state and local regulations, standards, and guidelines.
Areas of research
Our site is staffed with experienced principal investigators, sub-investigators and clinical research teams spanning:
Areas of the Clinical Trials Office
Our site offers comprehensive support for clinical research through a centralized clinical trials office designed to streamline operations and ensure consistency across studies. This centralized model enables us to maintain the specialized capabilities, oversight, and infrastructure to conduct both complex and routine trials with precision and efficiency.
Our processes are designed to ensure regulatory compliance, data integrity, participant safety, and timely research outcomes for our sponsors, making us a trusted partner for delivering high-quality clinical trial execution.
Research Regulatory Compliance provides regulatory affairs functions for all Network clinical research studies from initial contact through study archival.
- Start-up Regulatory
- Research training and qualifications (eg. CITI, CV, ML, IATA)
- Primary point of contact for all new study opportunities
- Facilitates CDA/NDA
- Engages clinical for study feasibility
- Coordinates Pre-Study Visit
- Processing technology and equipment requirements
- Engages research finance for contract and budget
- Informed consent form draft and finalization
- Essential document completion/collection (eg. 1572/IA, FDF)
- IRB preparation and submission
- Regulatory binder creation and maintenance
- Ongoing Regulatory
- Primary point of contact for IRB renewal, modification (amended/clarified study documents, add/remove study staff, etc.), closeout
- Coordinate and host regulatory focused monitoring visits
- Primary point of contact for study archival
Research Finance and Compliance provides comprehensive financial management of all network clinical research studies from site selection through study archival.
- Research Finance
- Medicare Coverage, cost, and fair market value analyses
- Budget development and negotiation
- Clinical trial agreement and grant funding documents
- Research Billing Compliance
- Protocol, ICF, MCA, budget, and CTA congruence
- Study Epic build and maintenance
- Study invoicing per contract and payment posting
- Billing audit process
- Payee and Address
- St. Luke’s University Health Network
801 Ostrum Street
Bethlehem, PA 18015 - Point of Contact
- Attention: Research Finance at researchfinance@sluhn.org
- Clinical Research Coordinators/Nurses
- Clinical Research Associates (data management, lab)
- Disease-specific study teams
- Back-up coverage across studies
- Standardized processes and tools
- All study staff required to complete Good Clinical Practices and Human Subjects Protection training through Collaborative Institutional Training Initiative (CITI)
- Central scheduler
- On-site and remote monitoring available
- Direct access to EMR granted upon signing Acceptable Use Agreement
- 10 business day notice needed for new access approval
- Unique username and password
- Access to study participants only
- Private space with high-speed wireless internet access
II, III, IV, registry, biomarker, IIT as satellite
Epic with Epic Research Module optimized
- Clinical Trials Pharmacy Coordinator (PharmD) and Technician
- Investigational drug stored separate from stock in locked pharmacy with restricted access
- Experience with temperature-controlled drug transport device and chain of custody
- Refrigeration: -20C freezer and -80C freezer storage available a key research locations
- 24/7 monitoring with alarm to pharmacy and engineering
- Temperature is calibrated yearly by engineering staff
- Systems are on generator back-up
- Investigational medication, chemotherapy, transport, and waste management policies in place
- Drug accountability: tracking, dispensing, inventory, and documentation of IP
- Ability to host on-site and remote monitoring visits
- All labs have CAP and CLIA certificates and licenses
- Normal ranges documentation available
- CV for lab director available upon request
- St. Luke’s facilities; no separate facility use agreements necessary
- Experience with retrieving tumor samples (block and slides)
- Experience with tissue/fluid biopsy collection (core needle, incisional, excisional, and FNAB
- Ambient (room temperature) refrigerated centrifuge
- -20 freezer in lab monitored and alarmed 24/7 and calibrated yearly by Biomedical staff
- -70 freezer in lab monitored and alarmed 24/7 and calibrated yearly by Biomedical staff
- Lab kit storage locked within Clinical Trials Office with restricted access
- CT scan, PET scan, MRI available
- Experience with central imaging which includes transfers of images
- Able to retrieve redacted images on disc
- Epic patient identification and recruitment through SlicerDicer and MyChart
- Screening provider-investigator schedules for eligible patients
- CRC/N monthly PO oversight meetings discussing safety, recruitment, retention
- Oncology: tumor boards, tumor registry, pathology reports
- Off-site
- Climate controlled
- Compliant with record retention standards and regulations
- CRM: Address
- Study archival occurs quarterly and records are retained in accordance with regulatory requirements and the agreed upon terms in the CTA.
- GRM
- 3449 Fox Street
Philadelphia, PA 19129
The Institutional Review Board is in compliance with 45 CFR 46, 21 CFR 50 and 21 CFR 56. To the extent these Federal regulations are in agreement with the ICH Guidelines. We are also in GCP compliance.
- Local: St. Luke’s University Health Network Institutional Review Board
801 Ostrum Street
Bethlehem, PA 18015 - IRB OHRP Registration: IRB 00002757
- FWA Number: FWA00003557 Expires: 19Sep2028
- 2025 FDA IRB Site Visit – no findings, no 483
- Full board review occurs once monthly on the 1st Tuesday of each month
- Exempt and Expedited submissions receive approval approximately 3 weeks from submission
- Submission deadline is the 20th of each month (two weeks prior to meeting date)
- Post-meeting turnaround of approved documents is 5-7 business days
- Conditional approvals extend timeline by 5-7 business days
- SLUHN IRB uses Cayuse, an electronic document platform for all submissions and tracking and all researchers must be compliant with research qualifications requirements to be granted access
- SLUHN IRB Fee Schedule
- CIRB approved for single IRB studies and mayb be requested for minimal risk studies
