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Clinical Studies

I3H conducts observational research studies at Penn Medicine and in collaboration with other academic institutions, health systems, and industry. The Clinical Studies division manages and oversees key aspects of this research, serving as a liaison among participating parties: principal investigators; clinicians; institutional review boards (IRBs); study subjects; sample collection, processing, and biobanking teams; data collection and analysis specialists; and more.

With myriad contacts throughout the University of Pennsylvania Health System, the Perelman School of Medicine, and the broader university, we can help expertly identify the optimal population for your research question. Our wide regional access enables us to provide sufficient numbers of study participants, even from rare disease populations. Fine-tuned techniques and technologies — from our innovative mobile phlebotomy unit to cutting-edge assays and data analysis — help streamline research projects, ensuring accuracy, accountability, and compliance throughout the process. A wealth of combined resources allows us to nimbly develop new tailored approaches, as needed.

Our Services

Supporting researchers from initial inquiry to study completion, the Clinical Studies team:

  • Assists in characterizing/profiling appropriate subject populations for the study of specific scientific questions 
  • Contributes to study planning and design
  • Writes study protocols for IRB review and approval
  • Coordinates with the IRB to obtain approval of protocol or study revisions
  • Helps locate participants that fit the required profile 
  • Recruits study participants
  • Reviews study specifics with subjects, including risks and benefits, and obtains informed consent for participation
  • Manages subjects’ personal health information and protects subjects’ privacy in compliance with federal requirements
  • Manages subjects over the course of a study, including sample collection, follow-up appointments, etc.

  • Performs blood sample collections, including the use of mobile phlebotomy to maximize patient compliance
  • Collects the necessary metadata to give researchers the clinical context of samples, including each subject’s age, vaccination history, history of COVID-19 treatment, etc.
  • Manages samples meticulously, documenting all sample handling prior to transfer for processing
  • Helps ensure studies are in ongoing compliance with University of Pennsylvania Regulatory Affairs and IRB requirements 
  • Liaises with Penn Medicine BioBank to share resources and expand the reach of both groups
  • Liaises with Hospital of the University of Pennsylvania and other Penn Medicine resources

Mobile Phlebotomy

Especially for longitudinal studies, our specialized mobile phlebotomy unit solves one of the most difficult problems with sample collection: participant compliance. 

For some studies, subjects are healthy donors; they have only occasional reasons to enter a medical setting. For other studies, participants may be long-term patients who have no desire to visit a medical facility more often than already necessary. In addition, most studies require blood draws at precise time points. The more time points needed, the greater the burden on the subject.

With our mobile phlebotomy unit, we take the sample collection process directly to the study participant. Our experienced, highly skilled mobile phlebotomy team arrives at the subject’s home or preferred location, identifies them, draws their blood, stores it for transport, and departs. Our typical mobile phlebotomy visit takes less than 10 minutes. Making participation quick and easy facilitates study enrollment and contributes to greater than 95% subject retention.

Coordination With Processing

From the subject’s arm to specialized blood handling procedures, to isolation of the final sample for analysis, the Clinical Studies division works hand in glove with the processing team in our Platform Assays division to ensure the seamless transfer of each physical sample and its associated information.

Our teams are in constant communication about upcoming studies with unique needs and ongoing studies in which real-world subjects can create real-world hiccups: scheduling snafus, dehydrated subjects unable to provide full samples, and other issues. Using our customized LabVantage platform, we ensure that all staff are continually updated on the status and location of every sample and are ready to respond should any issues with participants arise.

Coordination With Informatics

The Clinical Studies and Informatics divisions closely coordinate at the earliest and latest stages of a study. 

At the outset, we work with the principal investigator and the team who will analyze the data to identify the optimal study population before the protocol is ever written. Throughout the sample collection period, the Clinical Studies team gathers relevant metadata and uses it to classify subjects into various study subpopulations. At the final stage, we relay all relevant data points to Informatics in a de-identified format that links each set of information to the correct sample.

For More Information

 For questions or to engage with our Clinical Studies division, please complete our contact form.