Accel

Accel™ is a turn-key, cloud-hosted Statistical Computing Environment (SCE) developed by d-wise, an Instem company, designed specifically for small- to mid-sized life sciences organizations. It provides a fully validated, regulatory-compliant platform for biostatistics teams working on clinical trial data analysis and reporting, enabling seamless data sharing, program execution, and statistical analysis within a centralized and secure environment.

Pre-loaded with SAS, R, Python, and a comprehensive suite of essential productivity tools, Accel allows teams to continue working with familiar applications without disruption to existing workflows. Unlike traditional on-premise solutions, Accel eliminates the compliance gaps and maintenance burdens associated with deploying and validating software across individual computers, and can be fully deployed and ready to use within a matter of weeks.

Key Benefits

• Fully Validated and Compliant: Pre-built with turnkey validation and a regulatory-compliant infrastructure, ensuring seamless alignment with ICH, FDA, and GxP requirements, including 21 CFR Part 11 compliance.
• Eliminates IT Burden: As a fully centralized and managed system, Accel removes the need for internal IT teams to handle software installations, updates, or compliance validation.
• Expert-Led Data Migration and Support: Global specialists are available 24/7/365 to support seamless migration of existing data and workflows, ensuring continuity, compliance, and peace of mind during transition.
• Rapid Deployment: Accel's deployment model allows teams to get up and running with a brand new SCE within a few weeks, with minimal impact on ongoing projects.
• Centralized and Secure: Standardized folder structures, security models, and access controls ensure data integrity and consistency across teams and systems.
• Flexible and Scalable: Accel supports teams ranging from as few as two people up to 200 active users, with a capacity for up to 1,000 users, allowing organizations to grow without compromising efficiency or validation status.

Core Features and Modules

• Statistical Computing and Programming: Accel supports SAS 9.4 Office Analytics or Analytics Pro for Windows, Enterprise Guide, and SAS Studio, providing a robust environment for clinical trial data analysis and reporting. R is included for advanced statistical computing, and PyCharm is available for Python-based data science and automation, enabling teams to work seamlessly across multiple programming languages.
• Data Management: UltraEdit and UltraCompare allow users to efficiently edit and compare scripts, while SVN (Apache Subversion) provides version control and data integrity. FileZilla enables secure data transfers, and Box Tools offers cloud-based file storage and collaboration to keep datasets accessible and organized.
• Data Reporting and Audit Trail: Accel includes the Microsoft Office Suite for documentation and reporting, Adobe Reader for managing regulatory PDFs, secure modern web browsers for web access, and NotePad++ as a user-friendly text editor. An integrated audit trail traces user actions, file changes, and other activities to maintain regulatory compliance.

How Accel Works

1. Deployment: Accel is pre-configured and validated for rapid implementation, with deployment completable in a few weeks.
2. Migrate Data Seamlessly: Expert-led data migration services ensure teams achieve continuity and compliance when transferring processes to the new SCE.
3. Run Statistical Analyses: With SAS, R, and Python preloaded, teams can use the programming tools they are already familiar with, free from software inconsistencies or validation issues.
4. Get Support When Needed: d-wise provides 24/7 global support to resolve issues quickly and minimize interruptions to workflows.

Technical Specifications

• Deployment: Cloud-based, fully managed infrastructure hosted on Amazon Web Services (AWS)
• Licensing: Flexible, cost-effective subscription-based pricing
• Compliance Standards: Built with ICH, FDA, GxP, and Part 11 compliance in mind
• Pre-Installed Software: SAS, R, Python, and additional productivity tools
• Security: Standardized security models and controlled access
• Scalability: Supports up to 200 concurrent users

Accel is positioned within d-wise's broader Clinical Trial Analytics and Transparency portfolio and is trusted by biotech and pharmaceutical companies, including Dermavant Sciences, which adopted Accel to centralize its SCE, reduce IT burden, and maintain compliance across growing biostatistics teams with no disruption to drug development programs.