Clinical Research Cores
Below are the links to the most utilized cores that provide “fee for service” support to investigators conducting research with clinical data, inclusive of prospective and retrospective observational studies, comparative effectiveness research, health outcomes research, clinical trials, predictive analytics, and clinical informatics.
Clinical Research Collaboration Unit (CRCU) is a center within the PSOM’s Center for Clinical Epidemiology and Biostatistics (CCEB) that provides data support services for Phase I-IV, multi-center, randomized, clinical trials, patient registries, and cohort studies utilizing state-of-the-art technology and tools to ensure superior data quality.
Biostatistics Analysis Center is a service center within CCEB comprised of masters level biostatisticians, biostatistical programmers and data managers that provide biostatistical and epidemiological consulting services to investigators.
Office of Clinical Research (OCR) monitoring provides monitoring services to faculty who are conducting investigator initiated clinical trials. The monitoring role includes assistance creating study specific Data Safety Monitoring Plans (DSMPs), conduct of monitoring visits, monitoring reports, site training, query identification and resolution and study close out.
For additional information please navigate to the Forms, Tools and Templates page and select monitoring. Contact Lori Conley, at conley@upenn.edu to explore monitoring options and develop a quote.
OCR Regulatory provides subject matter expertise to faculty conducting (i) investigator initiated clinical trials, (ii) non-clinical IND enabling studies, and (iii) manufacturing for use in clinical trials, which make up the key components of a regulatory submission. In addition, the team manages Penn held INDs and IDE’s, trains, and qualifies faculty sponsors, performs IND and IDE exemption determinations, and provides intensive support to faculty translating research from Penn labs into the clinical development.
OCR Regulatory provides both free and fee-for-service support.
For an overall description of services offered by OCR Regulatory, please visit this page.
For more information on fee-for-service support offered, visit the OCR Regulatory fee-for-service page or contact us via psom-ind-ide@pobox.upenn.edu or 215-662-4484.
Investigational Drug Service (IDS) supports investigators conducting industry sponsored and investigator initiated clinical trials with investigational products. It manages procurement, storage, preparation, labelling and dispensing of investigational products. It will generate randomization schema for IITs. For more information, please contact PennIDS@Pennmedicine.upenn.edu
Center for Human Phenomic Science (CHPS) provides a physical location in the Perelman Center for Ambulatory Care (PCAM) for outpatient research studies and an inpatient unit on 1 Dulles for research studies that require extended stays. The unit provides specialized nursing services and supports the execution of high intensity clinical research studies under controlled conditions. For more information please contact chpsadmin@pennmedicine.upenn.edu
Institute for Biomedical Informatics (IBI) Clinical Research Informatics Core (CIC) provides data brokering and predictive analytics services of clinical data for clinical and translational research in which the goal is to learn actionable healthcare knowledge and develop impactful solutions for improving patient care.
Department of Medicine Clinical Trials Unit provides operational support for phase I-IV investigator initiated and industry sponsored clinical trials. Support ranges from consultation to provision of clinical research professionals such as CRCs, project managers, regulatory specialists and recruitment specialists. For additional information please contact Amanda Bear at baer2@pennmedicine.upenn.edu.
Translational Research Cores
The facilities below may be used for the development and testing of drugs and medical devices. They can assist researchers in bridging the gap between bench work and clinical studies. They may have experience working on IND and IDE applications. Please contact them directly for your specific requirements.
The Clinical (GMP) grade Vector Core at the Center for Advanced Retinal and Ocular Therapeutics (CAROT), University of Pennsylvania Perelman School of Medicine, provides FDA and EMA-compliant Pharmacology-Toxicology and GMP-grade Lentivirus and Adeno-Associated Virus vectors. The Core also provides CMC support for early phase clinical trials. For more information, please email to junwei@pennedicine.upenn.edu.
Clinical Vector Core (CVC) at the Children’s Hospital of Philadelphia (CHOP) provides FDA and EMA compliant Pharm-Tox and GMP-grade Adeno-Associated Virus (AAV), AAV diluent (Excipient), and Lentiviral (LV) vectors and manufacturing and CMC support for early phase clinical trials.
The PET Center is dedicated to continuing the advancement of molecular imaging and seeks to build a network of collaborators to conduct translational research using existing and new radiotracers and theranostic to help better understand the diagnosis, physiology and treatment of multiple diseases.
The Radioimmunoassay and Biomarkers Core offers over 170 high quality immunoassays, biochemistry services and gas chromatography-mass spectrometry (GC-MS) services. The lab follows practices consistent with Good Clinical Laboratory Practices (GCLP), and the College of American Pathology (CAP).
The Translational and Correlative Studies Laboratory (TCSL) offers sample processing and biobanking, molecular (PCR, RT-PCR, digital PCR), biochemical (Luminex and ELISA), flow cytometry, Digital Spatial Profiling (DSP), and Spatial Molecular Imaging (SMI) services. Custom assays can be developed upon request. The lab operates under GCLP-like principles. For more information, please click on the link to contact us.