Research Systems

PennVault CDMS is built on the Veeva Vault platform, a cloud-based, 21 CFR Part 11 compliant software package developed to help manage health authority-required records. 

PennCRMS is a software system designed to help principal investigators, study coordinators, and other faculty and staff track and report on nearly every aspect of a clinical trial. Paper-based processes are replaced with electronic processes, and data is aggregated for use in the CRMS, as well as potentially exported and interfaced for use in external systems such as a data warehouses and the electronic medical record.  PennCRMS provides study and patient management capabilities, as well as electronic data capture. 

The University of Pennsylvania has licensed LabArchives as its ELN of choice.  LabArchives is a web-based paper notebook replacement.

UPHS uses EPIC as the software for the electronic medical record system, known as PennChart..  All clinical documentation related to Penn Medicine patients exists and should be recorded in PennChart.  Clinical documentation related to patients is required in PennChart, but additional documentation and workflows are available to facilitate study and subject management, such as recruitment alerts, integration with the Patient Portal (myPennMedicine), patient reported outcomes, and questionnaires.

LabVantage LIMS is a commercial system offered to Penn Medicine laboratories to aid in laboratory management.  The primary focus is enabling research studies with sample barcoding/tracking/annotation.  Other relevant areas that have been supported for some labs are stability studies, equipment tracking, inventory management, tracking sample movement among on-boarded labs.

PennVault document management applications are built on the Veeva Vault platform, a cloud-based, 21 CFR Part 11 compliant software package developed to help manage health authority-required records. QualityDocs is used to house quality procedures and documents.  The application includes document workflows and lifecycles to meet and maintain GMP guidelines.  Quality documentation system is the first step to implementing a quality manufacturing system.

REDCap is a secure web platform for building and managing online databases and surveys. REDCap's streamlined process for rapidly creating and designing projects offers a vast array of tools that can be tailored to virtually any data collection strategy.

PennVault document management applications are built on the Veeva Vault platform, a cloud-based, 21 CFR Part 11 compliant software package developed to help manage health authority-required records. SiteVault is designed to manage the investigator site file or electronic regulatory binder. SiteVault allows for the centralized storage and use of documents such as protocols, informed consents, CVs, training certificates, and lab certifications. Paper certification and e-signature workflows are available in SiteVault.

PennVault document management applications are built on the Veeva Vault platform, a cloud-based, 21 CFR Part 11 compliant software package developed to help manage health authority-required records. Electronic Trial Master File (eTMF) is designed for the maintenance and storage of the essential documents for clinical trials as maintained by the sponsor. PennVault eTMF is designed to function for any type of trial, be it single site or multiple sites over multiple countries. The eTMF organizational structure is based on the DIA TMF Reference Model. The eTMF may be used for the storage of documents as well as the author, review, transmission of documents for e-signature and approval.