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. 

Used by/Available to

All PSOM Clinical Trials

Capacity Assumptions/Restrictions

User must have a PennKey with PSOM affiliation. 

Continuity and Security

21 CFR Part 11 Compliant and HIPAA Compliant.  No PHI should be stored.  

Cost

$40,000 per study

Support

Open a Helpdesk Ticket

We offer support during standard business hours.

How to Access

Please contact Jessica.chen@pennmedicine.upenn.edu to discuss the process.

PennCTMS 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 CTMS, as well as potentially exported and interfaced for use in external systems such as a data warehouses and the electronic medical record.  PennCTMS provides study and patient management capabilities, as well as electronic data capture. 

Used by/Available to

Available to all PSOM users

Capacity Assumptions/Restrictions

User must have a PennKey and PMACS account

Continuity and Security

21 CFR Part 11 Compliant and HIPAA Compliant.

Cost

None

Support

Open a Helpdesk Ticket

We offer support during standard business hours

How to Access

Please contact the Office of Clinical Research at tel:+1-215-662-4484 for process.

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

Used by/Available to

UPenn Community

Capacity Assumptions/Restrictions

No HIPAA, 21CFR, FISMA, Sensitive/Classified data should be stored.  Please see “What kinds of data are NOT appropriate to place in Penn’s LabArchives?

Continuity and Security

For information on continuity and security, please see Penn’s Electronic Research Notebook, Data Considerations.

Cost

None

Support

This is a self-service platform.  Please see Penn’s Electronic Research Notebook, Help and Support for help from the vendor about the system.

How to Access

Access Electronic Lab Notebook

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.

Used by/Available to

All UPHS and PSOM users

Capacity Assumptions/Restrictions

Users must have UPHS AD and UPHS network access. 

Continuity and Security

*Sensitive

Cost

None

Support

Open an Athena Ticket

We offer support during standard business hours.

How to Access

Request Access

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.

Used by/Available to

Laboratories at Penn Medicine

Capacity Assumptions/Restrictions

LabVantage is tracking ~1.5M samples as of September 2020 and supports around 60 different research teams, 700+ users, and 325+ studies.

Continuity and Security

The system is located in one of the UPHS data centers and is backed up nightly.  Both a PMACS account and LabVantage account are required for access and security is determined based on the research team and role.

Cost

For labs willing to take their turn in the queue, the only costs are a label printer, barcode scanner, and the label/ribbon consumables.  We ask that if our team dedicates time to your project, this effort is respected and matched.

Support

KACE ticketing system directly sends tickets to the LIMS team.  We offer support during standard business hours.

How to Access

Please contact ned.Haubein@pennmedicine.upenn.edu to discuss the process.

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.

Used by/Available to

PSOM Manufacturing Groups

Capacity Assumptions/Restrictions

User must have a PennKey with PSOM affiliation. 

Continuity and Security

21 CFR Part 11 Compliant and HIPAA Compliant.  No PHI should be stored.  

Cost

None

Support

Open a Helpdesk Ticket

We offer support during standard business hours.

How to Access

Please contact Jessica.chen@pennmedicine.upenn.edu to discuss the process.

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.

Used by/Available to

Available to all PSOM users

Capacity Assumptions/Restrictions

User must have a PennKey and PMACS account.

Continuity and Security

No 21CFR, FISMA, Sensitive/Classified data should be stored.

Cost

None

Support

Open a Helpdesk Ticket

We offer support during standard business hours.

How to Access

Access REDCap

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 consentsCVs, training certificates, and lab certifications. Paper certification and e-signature workflows are available in SiteVault.

Used by/Available to

All PSOM Trials.

Capacity Assumptions/Restrictions

User must have a PennKey with PSOM affiliation. 

Continuity and Security

21 CFR Part 11 Compliant and HIPAA Compliant.

Cost

None

Support

Open a Helpdesk Ticket

We offer support during standard business hours.

How to Access

Please contact the Office of Clinical Research at tel:+1-215-662-4484 for process.

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.

Used by/Available to

PSOM Sponsored Trials

Capacity Assumptions/Restrictions

User must have a PennKey with PSOM affiliation. 

Continuity and Security

21 CFR Part 11 Compliant and HIPAA Compliant.  No PHI should be stored.  

Cost

None

Support

Open a Helpdesk Ticket

We offer support during standard business hours.

How to Access

Please contact the Office of Clinical Research at tel:+1-215-662-4484 for process.