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 Computing 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 provide 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. For an estimate on regulatory services please contact psom-ind-ide@pobox.upenn.edu or call 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 extend 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.