- PLAN
- OPERATE
- MONITOR
- DELIVER
Clinical Operations Partner
Integrated Support
for Investigators.
Clinical operations for medical device and digital health trials, scoped to exactly what your study needs.
Who we support
Built for teams that need trials run right
Medical Device & Digital Health Companies
We run your trial operations so you can hit regulatory timelines without an in-house team.
Clinical OperationInvestigators & Research Sites
IRB submissions, documents and site coordination for investigator-initiated trials.
IRB & Site ManagementCRO Partners
Experienced CRAs for peak workloads, including monitoring-only and subcontract work.
Flexible CRA Resource
Services
Pick the scope you need. We run it precisely.
Clinical Operation
Timelines and site progress managed from study start-up to close-out.
Study Start-upTimeline ManagementEssential DocumentsMonitoring
On-site monitoring per GCP and protocol, for all sites or only the ones you choose.
SIVIMVCOVSDVSDRIRB & Site Management
IRB submissions and site communication, on schedule.
Initial · Amendment · Continuing ReviewSite CommunicationData & Document QC
Data and document checks, ready for audits.
CRF / eCRF ReviewTMF / ISF QCRWD · Registry · PMCF
Operations for post-market evidence studies.
Post-market Clinical EvidenceFlexible CRA Resource
Experienced CRAs on short notice.
Short-term CRAMonitoring-only
How we work
Three ways to work with us
Full-service Operations
We run clinical operations end to end, from start-up to close-out.
- Preparing your first trial
- No in-house clinical team
- One partner for a multi-site trial
Functional Support
Choose only the functions you need: monitoring, IRB, data QC and more.
- Outsourcing selected tasks only
- Monitoring for specific sites
- Document and data checks before an inspection
Short-term CRA Support
Experienced CRAs for the periods when your workload peaks.
- Peak-period staffing gaps
- Monitoring-only assignments
- CRO subcontracting
Tell us your scope, number of sites and timeline. We'll propose how to run it.
Talk to us about your scopeWhy INTS
Accountable from start-up to close-out
Hands-on Experience
Operational experience across medical devices, pharmaceuticals and IVD.
Direct Communication
One dedicated contact for the life of your study.
Real Accountability
We manage site and data progress, not just document submissions.
Process
From first contact to kick-off
- 1
Inquiry
Tell us your product, phase, number of sites and preferred timeline.
- 2
Scoping Call
We review the work and your sites together and agree on an approach.
- 3
Proposal & Quote
You receive a proposal covering scope, timeline, team and cost.
- 4
Kick-off
Once contracted, your dedicated contact starts with study start-up.
Tell us about your study.
Share your product, phase, sites and timeline. We reply within 1 business day (KST).