Clinical trials, diagnostics, and any work touching identifiable patient information carry the full Security Rule obligations: encryption, access controls, audit logs, and a documented risk analysis.
If your systems hold electronic records or electronic signatures supporting a regulated submission, they need validated access controls, audit trails, and record integrity. We build the IT controls; your quality team owns the validation.
Grant-funded and federally contracted research often carries flow-down cybersecurity requirements that arrive in the award terms rather than in a regulation.
Not a regulation, but the obligation that matters most. Investors, partners, and acquirers will examine how research data is protected, who can reach it, and what the audit trail shows.
Both examine MFA, backups, endpoint detection, and access governance. We close the gaps before someone else finds them.
Lab environments break the assumptions most IT is built on.
Sequencers, analyzers, and imaging systems frequently run unsupported operating systems mandated by the manufacturer. We segment and monitor them rather than breaking your warranty.
Storage, backup, and recovery designed for datasets that do not fit ordinary backup windows, with tested restores rather than assumed ones.
Secure sharing with CROs, academic collaborators, and partners that does not put your whole file store within reach of one shared link.
Who reached which dataset, when. The record investors and partners ask about, maintained continuously rather than reconstructed later.
A lab that doubles headcount in a year should not have to rebuild its IT. We design for the next stage, not just the current one.
24/7 monitoring, helpdesk, patching, and endpoint management, so issues are handled before your staff or patients notice.
EDR, MFA, email security, awareness training, penetration testing, and incident response, watched around the clock by our SOC.
Assessments, remediation, and audit-ready documentation for HIPAA, CMMC 2.0, NIST 800-171, FTC Safeguards, and Washington MHMDA.
Fractional security leadership for defense contractors and healthcare organizations that need a named security owner without a full-time hire.
M365 management, Azure, and GCC High for CMMC-scoped environments.
Ransomware-resilient backups with tested, documented recovery.
Yes, and this is common. We isolate those systems on segmented networks with monitoring, so an unpatched instrument cannot become the path into your research data. We do not force changes that void a manufacturer warranty.
We build and document the IT controls that support Part 11: access control, audit trails, and record integrity. System validation itself belongs to your quality function, and we provide the evidence they need.
Access governance with a continuous audit trail, encryption at rest and in transit, segmented storage so no single account reaches everything, and monitoring for unusual data movement.
Yes. We set up controlled sharing scoped to specific datasets and time windows, with a record of who accessed what.
Yes. We assess against a recognized framework, give you a scored view of where you stand, and prioritize the gaps most likely to surface in diligence.
Organizations typically spend between $125 and $225 per user per month for a fully managed plan, with regulated environments toward the upper range. Call (833) 465-5913 for a specific estimate.
With extensive experience in the life sciences sector, we understand the unique cybersecurity and IT challenges you face.
Our services are tailored to meet the specific requirements of life sciences organizations, ensuring optimal protection and efficiency.
We anticipate threats and implement proactive measures to safeguard your operations, going beyond reactive security.
Bytagig is a trusted partner for life sciences organizations, providing reliable and secure IT solutions that uphold the highest standards of integrity and compliance.
Research data cannot be restored from a competitor's copy. Schedule a free 15-minute call at (833) 465-5913.