The CRCU serves as a "Core Research Facility" within the University to allow researchers and investigators access to its services across a wide range of research programs and medical disciplines. These core services allow the CRCU to participate in various research programs within the University, as well as with external research-related entities. The CRCU provides a complete set of services to facilitate the collection, storage and management of clinical research data for any size research study conducted by University investigators and their collaborators. Whether the CRCU performs the myriad duties of a Data Coordinating Center for multi-center research networks or creates a simple database to organize cohort data, each project receives the right amount of specialized expertise and attention to ensure successful completion with accurate and reliable research data. The CRCU has extensive experience providing design, development and project and technology support services to the entire Penn Medicine clinical and translational research enterprise.
Speiser, Florence., MS
Role: Senior Manager, Research Development and Internal Operations QA
"The CRCU provides a complete set of services to facilitate the collection, storage and management of clinical research data for any size research study conducted by University investigators and their collaborators."
A vast variety of databases and specialized database modules are developed to support a vast variety of projects ranging from simple cohort studies and registries to extremely complex multi-site Clinical Research Networks that require Data Coordinating Centers (U01, U10) to conduct multiple concurrent clinical trials.
In many cases, several products like REDCap, Oracle, and Oracle Clinical are all used on one complex project to perform multiple functions required to support the project.
All databases and special database modules (subject tracking,
screening, eligibility, and randomization, data discrepancy resolution, data validation, validation rule violation resolution) are used to support all activities of all Units within the CRCU and the studies that CRCU is supporting.
* Cross functional coordination and training on applicable guidelines and regulations
* Project start-up regulatory consultation
* Project time line definition and management
* Research Network Development
-> Identify Collaborating Members
-> Establish Communication Protocols
-> Coordinate Collaboration Activities
-> Facilitate Results Dissemination
* Site Management
-> Develop Regulatory Documentation
-> Facilitate Protocol Training
* Filing and maintenance of investigator-initiated INDs/IDEs
* Informed consent review for compliance with ICH and HIPAA requirements
* Safety reporting to regulatory authorities (U.S. and international)
Services include consultation on design and informatics and data coordination strategies for research proposals and pilot studies. Services are often provided by CRCU members from the divisions of Research Technologies, Clinical Data Management, Project Management, Operations and Compliance, and Biomedical Research Computing, who have expertise across a wide range of technologies and extensive experience working with biomedical and clinical investigators in diverse disciplines. This expertise and experience includes development and implementation of studies of all sizes from small pilot studies to large-scale, multicenter clinical trials, collaborative clinical and patient-oriented research, and multi-institutional health services research projects.
"The CRCU has extensive experience providing design, development and project and technology support services to the entire Penn Medicine clinical and translational research enterprise."
"Microsoft SharePoint 2010 makes it easier for people to work together.
Using SharePoint 2010, your people can set up Web sites to share information with others, manage documents from start to finish, and publish reports to help everyone make better decisions. "
"Manufacturers of medical products such as drugs, vaccines, biologics and medical devices are required by law to report certain adverse reactions and complaints about their products in a timely fashion in all countries where the products are marketed or studied. As well as responding to these issues as they arise, manufacturers are increasingly looking to proactively identify safety issues by monitoring trends, identifying signals, and comparing products and incident rates with those of competitors.
Oracle AERS gives pharmaceutical companies the power to store and monitor adverse events encountered in clinical trials so that safety concerns can be addressed before a drug reaches the market. Oracle AERS pulls adverse event information from the Oracle Clinical database to Oracle AERS, therefore preventing duplicate effort and possible database discrepancies. If the details of a clinical adverse event reach the Safety department before the data has been entered into Oracle Clinical, then the users can pick the patient and investigator information directly from the Oracle Clinical database, thus reducing possible discrepancies."
"Oracle Clinical provides the life science industry with an integrated Clinical Data Management (CDM) and Remote Data Capture (RDC) application on the market. Oracle Clinical was built based on the extensive experience of hundreds of companies that conducted clinical trials—which gives Oracle Clinical an essential industry perspective. Unlike other vendor offerings, Oracle Clinical provides a single application architecture for both CDM and RDC. Oracle Clinical provides additional functionality in key areas such as integration, data collection, localization, and reporting.
More than 200 companies representing pharmaceutical, biotechnology, medical device, and contract research organizations have relied on Oracle Clinical to conduct more than 10,000 clinical trials, making it the market-leading clinical research solution. Oracle Clinical's scalability, ease-of-implementation, ease-of-use, and built-in compliance increase your return on investment with every study you initiate.
Because Oracle understands every aspect of clinical data management in a changing market, Oracle Clinical can help organizations create solutions for their specific data management and business challenges. Its combination of broad coverage and deep functionality offers unmatched benefits in all aspects of clinical data management."
"Oracle Remote Data Capture 4.6.2 provides an efficient, scalable electronic data capture system that can fully support complex clinical study designs. Clients who use Oracle Remote Data Capture have reported significant cost reductions of clinical trials from EDC.
Oracle Remote Data Capture 4.6.2 fully supports complex clinical study designs, including oncology trials. This dramatically improves the timeliness and quality of clinical trial information to enable faster study decisions and more timely feedback to clinical and site personnel, resulting in shorter time to market for new products. Flexible study support significantly reduces time to set up and maintain trials as intelligent guidance throughout the patient treatment path enables site personnel to quickly identify and respond to data for each patient. Furthermore, Oracle Remote Data Capture 4.6.2 leverages proven Oracle database technology to deliver superior performance and reduce risk from technology changes."
"A set of database and programming tools used to create customized solutions for data management, reporting, and workflow control."
"Oracle Database 11g is a single integrated platform that supports SQL, XML, and procedural languages (e.g., PL/SQL, Java, C/C++) in a simple fashion with high performance and scalability. The information below describes many of the features of the Oracle database that facilitate Datbase Application Development. This includes languages, tools, connectivity and technologies that are supported."
"One of the most time-consuming tasks within the drug development process is classifying verbatim terms to permit deriving standard medical and drug terms for use in analysis from the free text originally captured. The Oracle Thesaurus Management System (TMS) streamlines this critical and costly task by providing a centralized, globally available repository of dictionary terms and associated verbatim terms. Information in the repository is accessible through advanced searching and classification algorithms. TMS supports all dictionaries required by international regulatory authorities. Additionally, TMS can support and integrate with company/organization-specific dictionaries and legacy applications. The result is a global facility to standardize terminology use across dictionaries, computer applications, time, and organizations.
Oracle Thesaurus Management System addresses the complexities associated with managing global thesauri. Designed to manage and classify free text captured during the drug development process, TMS meets the needs of multinational pharmaceutical, biotechnical and medical device companies, contract research organizations, academic institutions and regulatory authorities by providing a worldwide, scalable terminology repository. Within the Oracle OLS application suite, TMS provides terminology services for Oracle Clinical, Oracle RDC, Oracle AERS and Oracle Life Sciences Data Hub."
"REDCap is a secure, web-based application for building and managing online surveys and databases. Using REDCap's stream-lined process for rapidly developing projects, you may create and design projects using 1) the online method from your web browser using the Online Designer; and/or 2) the offline method by constructing a 'data dictionary' template file in Microsoft Excel, which can be later uploaded into REDCap. Both surveys and databases (or a mixture of the two) can be built using these methods.
REDCap provides automated export procedures for seamless data downloads to Excel and common statistical packages (SPSS, SAS, Stata, R), as well as a built-in project calendar, a scheduling module, ad hoc reporting tools, and advanced features, such as branching logic, file uploading, and calculated fields."
"A clinical trials management tool managed by the Abramson Cancer Center. The CRCU works with this tool for studies conducted by Cancer Center investigators."