Strategic Clinical Operations Partnership
Mariliam provides comprehensive operational leadership across the entire clinical development lifecycle. From protocol design through database lock, we embed with your team to drive execution, manage risk, and deliver quality results on time and within budget.
🎯 End-to-End Operational Execution
Comprehensive accountability for operational planning and execution across Phase I-III clinical trials, with particular expertise in lean biotech environments.
- Complete ownership of trial budgets and forecasts, ensuring delivery within financial targets
- Operational input into protocols, ICFs, CRFs, monitoring plans, and study manuals
- Cross-functional study team management to achieve project deliverables
- Risk management and mitigation strategies throughout the trial lifecycle
- Timeline management with proactive issue identification and resolution
🤝 CRO & Vendor Management
Strategic development of RFPs and meticulous selection and oversight of CROs and external vendors to ensure optimal trial performance.
- RFP development and vendor selection for CROs, laboratories, and specialty vendors
- CRO oversight ensuring adherence to timelines for site start-up, recruitment, and monitoring
- Alliance partner relationship management across clinical-stage programs
- Performance tracking and vendor accountability through KPIs and metrics
- Communication and issue escalation between vendors and internal teams
🌍 Global Site Feasibility & Start-up
Identification, assessment, and qualification of investigative clinical sites globally with proven success across four continents.
- Country and site selection strategy aligned with enrollment feasibility
- Investigator identification and feasibility assessment
- Pre-study visits and site initiation visits (SIVs)
- Site readiness metrics implementation to improve timeline predictability
- Updated study start-up process implementation and optimization
📋 Regulatory & Compliance Support
Expert support for regulatory interactions and quality compliance, ensuring adherence to GCP and global regulatory requirements.
- IND application preparation and submission support
- Regulatory green light package review and approval
- Protocol and amendment preparation ensuring regulatory compliance
- Monitoring activity oversight through review of monitoring reports and QA-GCP audit reports
- Communications with investigators and site personnel on regulatory requirements
📊 Clinical Data & Quality Management
Comprehensive data management and quality oversight to ensure integrity and regulatory compliance throughout the trial.
- eCRF design and electronic data capture system implementation
- Data quality review through trend analysis and protocol deviation monitoring
- eTMF system selection and implementation
- Discrepancy resolution and database reconciliation processes
- Quality oversight tracking to ensure data availability for analyses
🔬 Program Development & Strategy
Strategic clinical development planning and operational input for program advancement from early to late-stage development.
- Participation in clinical development planning and partner discussions
- Operational and country-selection strategy for clinical programs
- Protocol design input ensuring operational feasibility and executional rigor
- Study logistics planning including supply chain management
- Cross-functional initiative leadership for process improvements
Tailored Solutions for Your Clinical Program
Every clinical program is unique. Let's discuss how Mariliam can provide the operational expertise and leadership your trial needs to succeed.
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