Building IT capabilites in life sciences
A.R.C. has worked with life science firms of all sizes to develop and execute on IT strategies, select and implement enterprise and line of business applications and build governance capabilities. We specialize in understanding the unique regulatory and compliance needs within the industry and tailor our guidance to support the needs of our rapidly growing clients. Whether you are preparing to launch a product, building the capabilities required for your first IND submission or working to integrate an acquired company, we bring extensive experience across multiple functional areas in support of your individual needs and concerns.
Our consultants have been in the life science industry for over a decade and have worked with companies of all sizes supporting the diverse needs of every aspect of life science technology. While many of our engagements are in support of regulatory and compliance requirements for 21CFR Part 11 and SOX, we are also often engaged to ensure the successful selection and implementation of non-regulated systems and develop internal IT and compliance capabilities.
Get in touch with us to set up a consultation.
Areas of Practice
IT Strategy, Roadmaps & Governance
Every client is unique in their goals, capabilities and culture. We can help develop a technology strategy that will support your growth and ensure that you have the people, processes and technology at the right time to execute on your company's strategic goals.
Implementing the right technology is critical to optimize your staff because you need to focus on what matters most in your company. A.R.C. has supported dozens of companies in their selection of enterprise and line of business applications. From ERP to regulatory systems, contracting systems to HRIS. We will help accelerate your selection process.
Cybersecurity is about more than firewalls and VPNs. Appropriate policies, training and preparation are just as important to your security program as any technology. There has never been more scrutiny of cybersecurity by board of directors than now. Being prepared is an organization wide effort. We can help.
21 CFR Part 11 System validation
Don't put your company's submission in jeopardy. Our risk based approach to system validation will streamline the process. Whether it's cloud, hosted or on-prem A.R.C. can help you and your team implement a defensible validation package or build a validation program to support your portfolio.
From litigation or regulatory scrutiny to cybersecurity events or changes in key personnel, our broad experience, unparalleled network of experts and grit will be an asset to your crisis response team. Some events you just can't plan for, but we have the flexibility and expertise to respond when others can't.
SOX 404b compliance is an important part of of your company’s corporate governance. Since it’s inception we have been working with publicly traded life science companies to define, perform and optimize their IT SOX controls.