Clinical Trial Management
From site feasibility to closeout , we deliver disciplined trial management with real-time oversight and inspection-ready execution.
Trial Governance Built for Operational Certainty
Most trial delays are operational, not scientific. Missed milestones, TMF gaps, fragmented oversight, and uncontrolled budget burn are governance issues that can disrupt execution. IQA’s Clinical Trial Management practice is designed to reduce these risks through proactive planning, connected oversight, and disciplined delivery.
From day one, we establish a centralized governance framework that connects site feasibility, activation, clinical monitoring, medical oversight, TMF discipline, and budget control into a unified, sponsor-visible operating model. Whether supporting a Phase I FIH study or a global Phase III program, we provide the visibility, coordination, and accountability needed to keep execution on track.
What Differentiates IQA
From Site Feasibility to Closeout - One Connected Operating Model
Every operational dimension of your trial - managed with oversight, visibility, and inspection readiness.
Site Feasibility
- Site feasibility assessments
- Investigator identification
- Country and site selection
- Competitive landscape analysis
Site Activation
- Regulatory and ethics submissions
- Site contract negotiations
- IRB / IEC management
- Site initiation visits (SIV)
Patient Recruitment & Enrollment
- Recruitment strategy and planning
- Screen failure analysis
- Enrollment forecasting
- Retention strategy
Clinical Monitoring
- On-site and remote monitoring
- Risk-Based Monitoring (RBM)
- Source Data Verification (SDV)
- Protocol deviation management
Site Operations Management
- IP accountability tracking
- Protocol amendment management
- Site issue escalation
- Urgent safety measures
Medical Monitoring
- AE / SAE medical review
- Protocol eligibility review
- DSMB support
- Medical query management
Audits & Inspection Readiness
- Internal and QA audits
- Mock inspection conduct
- CAPA management
- Regulatory inspection support
TMF Management
- eTMF structure and setup
- Document collection and review
- TMF completeness tracking
- DIA Reference Model compliance
Financial & Budget Management
- Study budget development
- Site payment management
- Budget burn tracking
- Change order management
Vendor & Third-Party Oversight
- Vendor governance framework
- KPI and performance tracking
- Central lab oversight
- IRT / RTSM management
Risk-Based Quality Management
- KRI and QTL monitoring
- Central statistical monitoring
- Quality tolerance limits
- ICH E6(R3) compliance
Study Closeout
- Site closeout visits
- IP reconciliation
- Final TMF reconciliation
- Database lock coordination
From Site Feasibility to Closeout - One Connected Operating Model
Every phase planned, governed, tracked, and inspection-ready.
Feasibility & Planning
Site selection, country strategy, protocol review
Site Activation
Regulatory submissions, contracts, SIVs, training
Enrollment & Monitoring
Recruitment, on-site & remote monitoring, RBQM
Operational Oversight
TMF, budget control, vendor management, medical monitoring
Audit & Inspection Readiness
Site audits, CAPA, inspection readiness, mock inspections
Closeout & Lock
Site closure, TMF finalization, database lock
Proprietary Solutions Purpose-Built for CTM
Unlike CROs relying on third-party tools, IQA operates clinical trials on solutions we built - giving your team stronger visibility, control, and inspection-ready execution.
A CTM Partner Built for Modern Trial Execution
We Deliver the Trial and Build the Supporting Technology
Prabandhan, TrialLattice, and InductiveEDC strengthen trial execution through connected oversight, operational visibility, and accountable delivery across data and operations.
RBQM by Default, Not by Request
Risk-based monitoring is embedded into trial oversight from the start, helping teams surface signals early and act before issues escalate.
Global Reach, In-Country Awareness
Our teams support trials across FDA, EMA, CDSCO, and PMDA environments with practical awareness of local regulatory and operational expectations.
Inspection-Ready from Day One
TMF discipline, QA practices, and documentation control are built into study execution from the beginning - not retrofitted ahead of inspection.
Operational Control Built Around Connected Workflows
Milestones, site performance, risk signals, and budget tracking are managed through a connected operating model designed for visibility and control from day one.
Streamline Your Clinical Trial Operations
Talk to our CTM team about your study. We respond within 1 business day.