Data capture, management, integrity and security are vital components of successful clinical trials. There are real pressures in the industry to meet clinical trial compliance and regulatory submission demands without disruption to your data processes. Dell can help reduce these pressures and protect your bottom line with a solution designed to automate segments of the clinical trial workflow and ease regulatory processes while keeping Good Clinical Practice (GcP) compliance front of mind.
With a comprehensive clinical trials solution from Dell, you can see vast improvements in process productivity with an infrastructure that speeds, improves and standardizes data collection, access, retrieval and submission. And to further support successful pharmacovigilance, our technology infrastructures scale easily to help meet your data management needs as they continue to grow, before and after commercialization.
The Move to Digital Clinical Trials
As the life sciences industry moves forward in its conversion to fully digital clinical trial management, Dell can provide data solutions designed for integration with key technologies, including Clinical Trials Management Solutions (CTMS), Electronic Data Capture (EDC) and supportive technologies such as Picture Archiving and Communication Systems (PACS). These technologies, when combined with a Dell data management solution, can greatly increase the accuracy and speed with which you conduct clinical trials while maintaining the flexibility you need when adopting adaptive clinical trial processes.
Clinical Trial Operations and Management
There are inherent risks in the field of drug development and commercialization. Maintaining compliance, expediting subject recruitment and trial enrollment, meeting primary endpoints, and the need for outsourced or offshore alliances along the development pipeline are some of the typical challenges this industry faces. And as Contract Research Organizations (CROs) are employed more frequently outside the U.S., keeping data available yet secure is key. All of these factors raise a need for centralized control over quality, security and privacy. To this end, Dell Unified Communications Solutions can help simplify adherence to compliance mandates from the following governing bodies and organizations:
- Food and Drug Administration (FDA)
- European Medicines Agency (EMEA)
- National Institutes of Health (NIH)
- American Medical Association (AMA)
- Health Insurance Portability & Accountability Act (HIPAA)
- Department of Health and Human Services (DHHS)
- Institutional Review Boards (IRBs)
- National Institutes of Health (NIH)
The issues surrounding clinical trials can be difficult to navigate from a technology standpoint. To help ensure that you spend only what you need to and that your purchases will meet your long term organizational strategies, your Dell account team can provide compliance-readiness consultation to facilitate Good Clinical Practice (GcP).
Solutions for Clinical Trials
A high-performance computing (HPC) cluster based on the Dell line of PowerEdge™ servers can give you the power and scalable capacity you need to maximize your returns in the area of clinical trials by providing fast processing of captured data and integration with a variety of data sources for real-time access to information by concurrent users. Dell HPC clusters provide additional value in the form of simplified IT management, advanced cooling capabilities and high levels of energy efficiency.
On the data-management side, Dell™ PowerEdge™ Servers running VMware® Infrastructure 3 virtualization software can offer simplified data management, better resource utilization and cost-effective scalability to your facility by allowing you to run more applications on fewer servers. In instances where personnel in remote locations need access to multiple applications, server virtualization can streamline access to the data they need by placing it all on the same server. To meet your long-term storage needs, Dell storage-area networks (SANs) and modular tape libraries simplify data management and archival needs while providing high levels of availability and reliability.
Dell can also help you simplify mobile communications and improve data access between onsite and remote clinical trial management personnel with a Dell Unified Communications Solution. Unified communications allow the immediate flow of information to your field-based teams when and where they need it with connectivity to a broad range of mobile devices.
And don’t forget about security. Dell data solutions are available with high levels of data protection and security from leading industry partners, including the latest in encryption, authentication, threat defense and network security products. Our Latitude series laptops can provide world-class security with features such as an Integrated Smart Card Reader that requires both a card and password for access, Trusted Platform Module 1.2 with an optional UPEK® finger print reader and Wave Embassy™ Trust Suite available on some models. These features combined can deliver leading edge security and protection from hackers, thieves and malware.