SIKICH
At Sikich, we empower life sciences organizations through strategic planning, regulatory expertise, and digital modernization. From inception to commercialization, we specialize in planning, regulatory, quality, and compliance, leveraging cutting-edge technologies like Oracle NetSuite, Honeywell’s TrackWise Digital, and Kneat’s solutions to streamline operations and accelerate innovation.
Our tailored approach combines deep industry knowledge with advanced digital tools, ensuring compliance, enhancing efficiency, and reducing time-to-market for life-changing therapies. A focus on built in audit trails, roles-based control and automated reporting ensure compliance with FDA 21 CFR Part 11, SOX and EU Annex 11. With a commitment to precision, integrity, and transformation, we help companies navigate complex regulatory landscapes and embrace the future of life sciences with confidence. Plan smarter. Modernize faster. Innovate with impact.
FEATURED CONTENT
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Sikich’s SuiteSuccess for Life Sciences, built on NetSuite, helps companies grow from pre-revenue to commercialization in a fast, painless manner that ensures compliance and allows users to focus on what they do best: developing new medicines for patients who need them.
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You can transition from disparate data sources, inconsistent data management, and risk-prone compliance to a business culture that thrives on insight, streamlined and secure data management, and efficient, low-risk compliance practices. The Sikich life sciences team can help you achieve this quickly with industry-optimized cloud software and a wealth of expertise.
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CROs may repeatedly perform projects for the same clients, but, for many of them, there is never any assurance that clients will commit to more. That leaves their accounts vulnerable to a competitive takeover. Read about how study execution and applications must be improved in order to thwart a takeover.
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Consistently providing excellent client experiences is one of the hallmarks that separates the most innovative and value-focused CROs from the rest of the field. To modernize and simplify the technologies that serve clients, integrate proven software systems into a cloud environment optimized for CROs.
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In the last ten years, Sikich has been able to help a number of pharmaceutical companies and Clinical Research Organizations (CRO) build technology platforms that enable them to run and grow their businesses. While the two types of companies share some concerns and trends, CROs are probably more challenged and limited by the choices of software tools that are available to them.
CONTACT INFORMATION
Sikich
1415 W. Diehl Rd. Suite 400
Naperville, IL 60563
UNITED STATES
Phone: 630.364.7965
Contact: Nichole Adams
FEATURED ARTICLES
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Anticipate regulatory shifts and supply chain hurdles with agile scenario planning. Move beyond fragmented systems to build a resilient, data-driven foundation for a volatile industry landscape.
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Ensure long-term GxP compliance and audit readiness by centralizing fragmented records. Learn to preserve data integrity and reduce IT overhead while keeping vital information accessible.
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Explore how transparent decision-making and operational integrity are redefining value for early-stage life science ventures, navigating the path from discovery to market.
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Archiving legacy QMS systems into a centralized platform reduced costs, simplified access, and improved efficiency for a global diagnostics company undergoing quality process harmonization.
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Designed for leaders and professionals in the life sciences sector, this piece provides a practical framework for transforming data management into a catalyst for efficiency, compliance, and long-term innovation.
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Uncover how biotech firms can harness emerging technologies and other AI-driven innovations to shape the future of data-powered healthcare and scientific discovery.
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Explore ERP readiness for life sciences companies and, when QuickBooks falls short, how ERP systems support complex compliance needs.
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In today’s development landscape, where speed and resilience must go hand in hand, adopting a "Shift Left" mindset transforms testing from a bottleneck into a catalyst for innovation.
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As the U.S. FDA is impacted by layoffs that threaten its oversight capabilities, the importance of robust software and manufacturing process validation has never been more critical.
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Centralizing direct spend with the right tools enables you to manage critical inputs within the ERP and organizations to gain visibility for accurate demand planning and supplier performance tracking.