Newsletter

In biotech, innovation headlines dominate: new platforms, AI-powered drug discovery, and breakthrough trials. But behind every milestone lies an often-invisible foundation—IT infrastructure.

In the post-pandemic era, as biotech organizations return to labs, open new offices, or scale globally, infrastructure has become a strategic differentiator. Companies that embraced cloud-first systems—designed for secure, flexible, and compliant work—are now ahead in agility, collaboration, and speed.

Meanwhile, companies relying on outdated VPNs, siloed systems, and reactive IT models are encountering friction that impacts productivity, morale, and compliance. Whether you’re a startup preparing for your first IND or a growing biotech managing global CRO relationships, the strength of your infrastructure now shapes your success.

What Cloud-First Infrastructure Enables

A cloud-first infrastructure isn’t just about removing servers. It redefines how science gets done across locations, teams, and partners:

• Real-Time Collaboration: Cloud platforms allow teams to access, analyze, and share data instantly—from lab to office to home. Researchers, CROs, and partners can co-develop protocols, run analyses, and communicate without file versioning delays or email chains.
• Location-Agnostic Productivity: Cloud infrastructure supports hybrid and remote models seamlessly. Teams no longer depend on physical networks or clunky VPNs to access critical data. Scientists can initiate jobs, track instruments, and review findings from anywhere.
• Compliance by Design: HIPAA, GDPR, and FDA 21 CFR Part 11 compliance can be baked into infrastructure from day one. Cloud-based systems support secure logins, audit trails, access controls, and data retention—all configured for regulatory alignment.
• Scalability for Science: As data volumes grow (genomics, imaging, real-world evidence), cloud-based compute and storage scale on demand. Companies can support rapid experimentation, data warehousing, or trial scale-up without waiting on IT procurement.
• Frictionless End-User Experience: Tools like single sign-on (SSO), multifactor authentication (MFA), and centralized file access eliminate user frustration. This not only boosts productivity—it also increases adoption of compliant workflows.

Cloud-first companies are seeing shorter cycle times, smoother audits, and stronger employee satisfaction—all essential for biotech’s fast-paced, high-stakes environment.

Common Infrastructure Gaps Slowing Biotech Down

Companies that haven’t transitioned to modern infrastructure face a range of challenges that go beyond IT:

• Disjointed Systems: Researchers use multiple logins, siloed drives, and manual data transfer processes—slowing work and increasing error risk.
• Overburdened IT Teams: Support tickets spike as employees encounter performance lags, access barriers, and versioning issues.
• Security Risks: Legacy systems lack endpoint protection, encryption, and modern identity frameworks—making companies vulnerable to cyberattacks or compliance failures.
• Lost Productivity: Time spent “working around” infrastructure—babysitting downloads, fixing permissions, manually archiving data—is time lost on science.
• Morale Erosion: Frustration with IT leads to disengagement, especially among high-performing talent used to seamless digital tools during remote work.

These gaps are especially pronounced in companies that grew rapidly or pivoted through COVID without re-architecting their infrastructure for long-term flexibility.

Execution Steps for Modernizing Infrastructure

Whether you’re catching up or starting fresh, these six actions create a roadmap to a cloud-first, compliance-ready IT environment:

• Cloud-Readiness Assessment: Conduct a full infrastructure audit. Evaluate file systems, compute capabilities, network design, access points, and user workflows. Identify pain points and technical debt.
• Centralize Identity & Access: Implement SSO and MFA for secure, simplified login across applications and devices. Eliminate redundant credential systems and permission sprawl.
• Migrate to Encrypted Cloud Storage: Move GxP and research data to secure cloud platforms. Use automated backups, role-based access, and retention policies for audit readiness.
• Adopt Cloud-Native Collaboration Tools: Standardize platforms such as Microsoft 365, Google Workspace, or Slack (with compliance layers). Ensure integrated communication, file sharing, and version control.
• Integrate Scalable Cloud Compute: Enable scientific teams to run resource-intensive jobs in cloud environments like AWS, Azure, or GCP. Set controls for performance, cost, and access.
• Design for Compliance: Map infrastructure and processes to regulatory frameworks. Automate audit trails, log access events, and validate workflows per 21 CFR Part 11 and HIPAA standards.

For early-stage companies, this is a strategic opportunity to build right from the start—with flexible, future-ready systems that won’t require costly retrofitting.

How Celito Supports Biotech Infrastructure Transformation 

Celito partners with biotech organizations to design and implement modern, cloud-first infrastructure built for scale, speed, and security. We bring deep understanding of scientific workflows, regulatory demands, and user needs—ensuring that infrastructure works not just for the business, but for the people doing the work.

Our difference lies in the combination of:

• Life Sciences Expertise: Our team understands the nuances of regulated biotech operations—QA systems, validated environments, and secure research data management.
• Return-to-Work Readiness: We design IT environments that support hybrid, lab-based, and remote models equally—creating seamless transitions between locations.
• Security Built-In, Not Layered On: SSO, MFA, encrypted storage, endpoint protection, and email security are embedded from the ground up, not added after launch.
• User-Centered Execution: We reduce friction, simplify access, and remove IT barriers—so scientists, QA, and leadership can focus on execution, not troubleshooting.

Celito Services Include:

• Infrastructure & Cloud Readiness Assessments
• Network Design & Hybrid Connectivity
• Secure Cloud Storage & Migration
• Identity & Access Management (SSO/MFA)
• Cloud Compute & Data Flow Integration
• Regulatory-Aligned IT Design (HIPAA, 21 CFR Part 11, GDPR)
• Ongoing Managed IT & Security Services

From startups building their first environment to growth-stage biotechs scaling operations across sites, Celito helps build infrastructure that empowers teams, protects IP, and enables confident compliance.

Conclusion: Infrastructure Is a Strategic Multiplier

In biotech, infrastructure is no longer just an IT concern—it’s a strategic asset that defines how fast, secure, and collaborative a company can be. Cloud-first infrastructure enables real-time science, seamless scaling, and confident compliance. It turns IT from a bottleneck into an accelerator—and from a cost center into a driver of culture and retention.

Celito helps biotech companies architect infrastructure that not only supports innovation—but strengthens it.

References

• FDA 21 CFR Part 11 Overview
• HIPAA Security Rule Summary
• FDA Cybersecurity for Industry Guidance
• GDPR Compliance Guide