Proven statistical computing environments for life sciences leaders.

Organizations typically set up a statistical computing environment during the early phases of clinical development, often starting in Phase I trials. When it comes to environment set up, the earlier the better. Organizations who begin in the pre-clinical stage benefit from the additional time to thoroughly vet requirements and ensure the environment is optimized to meet evolving demands.

Early implementation must ensure that the data infrastructure is robust enough to handle the increasing complexity and volume of data as the trials progress. Establishing a validated environment early on ensures that all analytical processes comply with regulatory standards from the very start, reducing the risk of non-compliance issues later in the development process. Strong Tower’s expertise in creating statistical computing environments for life sciences ensures that your setup is both scalable and compliant, seamlessly supporting your journey from the lab to clinical trials and into the market.

When selecting a statistical computing solution, organizations often choose between SAS, a closed-source solution known for its robust analytics and regulatory compliance, and R, an open-source solution favored for its flexibility and extensive library of packages. SAS requires licensing fees but is unparalleled in its reliability for regulatory submissions. Alternately, R is cost-effective and customizable but requires more expertise for validation and support.

Strong Tower specializes in deploying and managing both validated and unvalidated environments, ensuring that your setup aligns with regulatory requirements and organizational goals. Whether you choose SAS, R, or a combination of both, our expert team will guide you through the setup and management process, ensuring that your statistical computing environment is secure, compliant, and tailored to your specific needs. We provide ongoing support and customization to help you leverage the full potential of your chosen statistical computing environment, including robust data management solutions for your clinical development journey.

When selecting a statistical computing environment, organizations should prioritize scalability, robust analytics capabilities, data security, and compliance with regulatory standards such as 21 CFR Part 11. It is essential to have systems that support advanced statistical methods, version control, and audit trails to ensure data integrity and traceability. Strong Tower’s environments are designed to integrate seamlessly with existing systems, offering comprehensive validation services to ensure compliance and streamline regulatory submissions.

While statistical computing environments are essential to a life science organization’s success, the failure rate is high for these complex implementations. The right partner will have a proven methodology and a flawless track record of success. Look for a repeatable and predictable implementation process, including evidence that your partner is anticipating and addressing potential challenges proactively. At Strong Tower, we call our methodology The Strong Protocol.

The right partner will be focused on designing, implementing, and maintaining a statistical computing environment tailored to your specific needs today and tomorrow. They will ensure the environment is optimized for performance, regulatory compliance, and data integrity—even as regulatory scrutiny increases. In addition, a true partner will provide continuous support and proactive maintenance; reducing downtime, maximizing the longevity of your environment, and improving the efficiency of data analysis.

Look for a partner that is committed to your success well beyond the initial environment set up. Ideally, they will also provide robust data management solutions to support you as you enter the clinical and commercial phases.

Strong Tower ensures regulatory compliance by adhering to industry best practices and regulatory guidelines such as GxP, 21 CFR Part 11, and ICH guidelines. We implement rigorous validation processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), to ensure that all components of the statistical computing environment meet the required standards. In addition, our continuous monitoring and audit trail capabilities ensure ongoing compliance, providing you with the confidence that your data management processes are secure and regulatory-ready.