Does 21 CFR Part 11 apply to our site or just to sponsors?▼
Sponsors are responsible for the EDC and other systems they provide, but if your site keeps records electronically that sponsors or FDA rely on, like eSource, eRegulatory binders or electronic signatures on site documents, Part 11 expectations apply to those systems. FDA guidance focuses on access control, audit trails, signatures and validation proportionate to risk. Your quality lead decides how your site meets those expectations. We handle the infrastructure: controlled accounts, protected logs, backup and documentation of how the environment is managed.
How should we give sponsor monitors access to source documents remotely?▼
Through a system that limits each monitor to their own study and logs what they view, not a shared drive or emailed scans. Many sites use an eRegulatory or remote monitoring platform built for that purpose. We configure accounts with MFA, set expiration dates tied to the study, block downloads where your SOPs require it and remove access at study close. That protects other sponsors' data and the subject information that doesn't belong to that monitor's protocol.
Our coordinators share the PI's login to enter data. Is that really a problem?▼
Yes. GCP and Part 11 both depend on records being attributable to the person who created them, and shared credentials break that. It's also a frequent observation in sponsor audits and FDA inspections. The fix is giving each coordinator their own sponsor and site accounts with appropriate delegated rights, which the delegation log should already reflect. A password vault and single sign-on, where sponsors allow it, make individual logins nearly as fast as sharing.
How long do we need to keep study records, and can you back them up that long?▼
Retention comes from FDA regulations, ICH E6 guidance, sponsor contracts and sometimes state law, and it often runs years past study close. Your regulatory lead and sponsor agreements set the actual period. We design backup and archive storage to meet it, with immutable copies so records can't be altered or encrypted, and restore tests that open real documents from closed studies. That way a records request years later doesn't become an emergency.
We are a research department inside a medical practice. How do we keep trial work separate?▼
Start with access: research staff, monitors and sponsor devices should reach only the research systems and the subject records needed for each protocol. We separate research file shares, apply role-based groups in the EHR where possible and put sponsor-provided devices on their own network segment. Your HIPAA authorization and IRB requirements govern what can be shared. We make the technology enforce those boundaries so practice and research data don't mix.
Do you support sites outside our home region?▼
Yes. Most of our work is remote, delivered by U.S.-based engineers, which suits research networks with sites in several cities. For on-site needs, like a new clinic buildout or failed network equipment, we handle it locally near our offices or dispatch a vetted local technician who follows our engineer's direction. We support research sites in Texas and nationwide, using the same identity, device and monitor-access standards across every location. New sites start from that baseline on day one.
Do you provide Clinical Research Sites IT Services in Houston and nearby areas?▼
Yes. LayerLogix is based in the Greater Houston area and delivers clinical research sites IT services to businesses across Houston and the surrounding communities, including The Woodlands, Spring, Katy, Sugar Land, Conroe, Cypress, and Pearland. For most Houston-area clients we can be on-site the same day when something needs hands-on attention, and our help desk is available during business hours, with after-hours emergency support. Call 713-571-2390 to check coverage for your specific address.
What does Clinical Research Sites IT Services cost for a Houston business?▼
Pricing depends on your size and what you need, so we do not publish a one-size-fits-all number — but Houston businesses generally pay a flat, predictable monthly fee rather than surprise hourly bills. We start with a free, no-obligation assessment of your current setup, then give you a clear quote in plain English with no hidden costs. That way you know exactly what you are getting and what it costs before you commit.