The operational layer, fully covered
Full Operational Support, From Start-Up to Close-Out.
MDTrials provides the operational layer around clinical research at the site — from the first feasibility request through close-out and record retention.
Scope is adapted to the clinic, investigator and study rather than forced into a one-size-fits-all package.
Feasibility to first patient, handled
Study start-up
- Feasibility and site qualification coordination
- Research-ethics submissions and amendments within assigned site responsibilities
- Essential-document collection and investigator-site-file set-up
- Training records, delegation and protocol-specific workflow set-up
- Sponsor and CRO start-up communication and readiness tracking
Every dollar tracked, every invoice reconciled
Contracts, budgets and finance
- Study budget review and site cost modelling
- Clinical trial agreement coordination and negotiation support
- Per-visit, per-procedure and conditional-cost tracking
- Invoicing, payment tracking and reconciliation
- Financial visibility so the site understands what work has been performed and what remains outstanding
Coordination that keeps a study moving
Study conduct
- Clinical research coordinator support and supervision
- Participant recruitment and retention planning appropriate to the study and clinic
- Visit scheduling and protocol-workflow support
- Source-document and essential-document quality controls
- EDC and data-entry support and query resolution within delegated roles
- Monitoring-visit preparation and follow-up
- Protocol deviation identification and escalation
Audit-ready by habit, not scramble
Quality and close-out
- Onsite and Remote Monitoring
- Audit and inspection readiness maintained as routine site practice
- Site-level CAPA support within assigned responsibilities
- Study close-out and financial and document reconciliation
- Record-retention and archiving planning in line with applicable requirements and study agreements
Frequent Questions
- What services does an SMO provide to a research site?Broadly: feasibility and start-up, ethics and regulatory document support, contracts and budgets, coordinator staffing and supervision, recruitment support, documentation and data-entry quality, monitoring readiness, and close-out and archiving.
- Can we use only part of the service?Yes. Scope is adapted to the site — some clinics need full operational support, others need targeted help with budgets, coordination or document control.
- Who employs the coordinators?Coordinator arrangements depend on the site model and are agreed as part of the partnership. In every case supervision, training and delegation are documented.
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The infrastructure, so you can focus on care.
Budgets, coordination, training and close-out — the operational backbone of a study, handled so your team can focus on patients.