Infracore helps biotech company in liquid biopsy diagnostic space go from R&D to commercialization in 6 months

Biotech companies often start as research organizations and transition into commercial operations as their products and services gain traction. A biotech company with a promising new diagnostic test for colon cancer approached Infracore for urgent assistance in transitioning from a research and development operation to a commercial entity. The client needed help with achieving HIPAA compliance, upgrading their collaboration platform, moving their infrastructure to the cloud, implementing IT controls for the CLIA Lab, and assisting with the rapid growth of their nationwide sales and support staff.

Business Needs and Challenges:

The client had several challenges that needed to be addressed:

• Comply with HIPAA regulations (to accommodate actual patient samples and patient health data, instead of limited/anonymized samples, as well as dealing with medical billing)
• Upgrade email and collaboration platform
• Improve robustness of the IT infrastructure to support 24x7 operations
• Implement IT controls for the CLIA Lab to ensure compliance with regulatory requirements
• Provide IT infrastructure to support the rapid growth of their nationwide sales, customer service and back office billing staff

Solution:

• • Fully managed on-site IT department with Service Desk
    • As a research organization, our client had managed to operate with a traditional managed service provider (MSP). The MSP would come on-site once or twice a week as needed and would perform all other work remotely according to a standard set of policies. With the goal of rapid commercialization, the support model had to be upgraded.
    • Based on experience, Infracore recognized that a seamless integration with the client's team was necessary. We embedded a dedicated, full-time team to run the IT function for this client. The amount of work required on such an challenging timeline meant close, ongoing collaboration with various stakeholders in the organization working on other parts of the effort. Our team consisted of an IT Manager, a Systems Administrator and a Desktop Support Specialist.
    • Our fully managed team was onboarded, backed up and overseen by an Infracore VP of Technology. The IT Manager and VP worked to build out end-user support capabilities and then focused on working with other department heads to develop and execute a comprehensive IT roadmap to support the commercialization efforts.

• • Migration of on-premises infrastructure to the AWS cloud
    • Prior to Infracore, occasional system downtime was tolerable as a research organization with a limited budget, but would no longer be tolerable as a commercial operation with a 24x7 production line. Further, the existing server and storage equipment was aging, and dealing with it would present a complication to a planned facility move the following year.
    • Infracore engineers migrated essential workloads to the AWS cloud, including the Laboratory Information Management System and several components of the lab management systems. These systems needed to be configured to specifications approved by the client’s HIPAA compliance officer to ensure data at rest and in transit was encrypted, along with other HIPAA requirements.

• • Migration of collaboration platform to Microsoft 365
    • The client started off using a limited version of Google’s G-Suite for document sharing and on-premises Exchange for email. With rapidly evolving compliance environment and the need for many new employees to be productive, Infracore migrated the Exchange server to Exchange Online and the G-Suite collaboration environment to SharePoint Online.

• • Work with the lab and compliance teams to build compliant IT processes
    • While Infracore is familiar with compliance requirements, we take direction from our client as to the specific solutions/controls with which they are comfortable. Infracore’s IT Manager and VP worked with the head of laboratory operations and the Chief Compliance Officer to implement endpoint policies (such as password policies, automatic lockouts, immutable logging, and privacy filter screens on computers visible from afar).
    • Further controls needed to be developed for patching/updating sensitive/validated systems in the CLIA Lab. Infracore worked with the Head of Quality to develop a process for performing updates on in-scope validated systems.
    • Infracore also developed compliant backup and recovery systems for the production lab equipment.

• Build out new sales, billing, and customer service departments
  • A research organization has limited need for customer-facing units such as sales, billing and customer service; these areas all had to be organized quickly. Infracore deployed new workstations under Microsoft Endpoint Manager control and developed processes for onboarding remote workers. We also worked with call center software consultants to build a new VoIP-based telephony solution to handle inbound customer service inquiries.

End Results:

After a 6-month long effort that involved dedicated project specialists in addition to the full-time team, the client was able to meet their target go-live date. The company’s headcount grew from around 45 to more than 100 people because of the commercialization efforts.