Services

Clinical Operations Services

From full-service operations to short-term CRA support, choose only the scope your study needs.

Clinical Operation

Timelines and site progress managed from study start-up to close-out.

Study Start-upTimeline ManagementEssential Documents

What we do

Study start-up: site selection, contract and budget negotiation support, activation
Study-wide timeline and milestone tracking with regular status reports
Enrollment tracking and issue management by site
Preparation and review of essential documents

A good fit when

You don't have a clinical operations team in-house
You want one point of control across multiple sites
Your trial timeline is tied to a regulatory submission

Monitoring

On-site monitoring per GCP and protocol, for all sites or only the ones you choose.

SIVIMVCOVSDVSDR

What we do

Site Initiation, Interim Monitoring and Close-out Visits (SIV, IMV, COV)
Source Data Verification and Source Data Review (SDV, SDR)
Review of protocol deviations and adverse event reporting
Visit reports and follow-up of action items

A good fit when

You need monitoring coverage for some sites only
You need CRAs with medical device trial experience
You want visit reports and follow-ups handled consistently

IRB & Site Management

IRB submissions and site communication, on schedule.

Initial · Amendment · Continuing ReviewSite Communication

What we do

Preparation and submission of initial IRB packages
Tracking of amendments, continuing reviews and final reports
Day-to-day communication with PIs, study nurses and CRCs
Responses to site requests and IRB queries

A good fit when

You need IRB and document support for an investigator-initiated trial
IRB timelines differ across your sites
You want a single point of contact with your sites

Data & Document QC

Data and document checks, ready for audits.

CRF / eCRF ReviewTMF / ISF QC

What we do

CRF and eCRF data review with query management support
TMF and ISF structure, completeness and version checks
Data cleaning progress tracking
Document readiness for audits and inspections

A good fit when

You want a second look at data quality before database lock
Your TMF or ISF filing has fallen behind
You are preparing for a regulatory inspection or sponsor audit

RWD · Registry · PMCF

Operations for post-market evidence studies.

Post-market Clinical Evidence

What we do

Operational planning for registries and observational studies
Site operations for Post-Market Clinical Follow-up (PMCF) studies
Multi-site data collection scheduling and quality control
Progress reporting and document management

A good fit when

You need PMCF evidence, for example under EU MDR
You are planning a study based on real-world data (RWD)
You need a post-market study run steadily over a long period

Flexible CRA Resource

Experienced CRAs on short notice.

Short-term CRAMonitoring-onlySubcontract

What we do

Short-term CRA support during peak workloads
Monitoring-only engagements for site visits
Subcontract work for CROs
Work performed under the sponsor's or CRO's SOPs and templates

A good fit when

Your CRO is temporarily short of CRAs
You need coverage for specific sites or a set period
You need to bridge a gap until a new hire starts

FAQ

Clinical Operations Services