Our Services
End-to-end clinical research support — from document development to international site management, monitoring, and audit readiness.
Protocol, Consent & Source Document Development
Including Templates
We develop research-grade documents that meet FDA, ICH-GCP, and sponsor requirements. Every document is built with your study protocol in mind.
Best For
What's Included
- Study protocol development and review
- Informed consent form (ICF) drafting — compliant with 21 CFR Part 50 and ICH E6(R3)
- Source document templates (CRFs, visit checklists, deviation logs)
- Standard operating procedure (SOP) development
- IRB submission preparation (local and central)
- Protocol amendment management
- Regulatory binder setup and maintenance templates
General Consulting Services
Strategic Research Guidance
Expert strategic consulting for research challenges — from feasibility assessment to regulatory strategy and operational optimization.
Best For
What's Included
- Study feasibility assessments and risk analysis
- Regulatory strategy and FDA liaison support
- Budget and timeline planning
- Sponsor and CRO vendor oversight guidance
- Research gap analysis and corrective action planning
- IRB strategy — central vs. local board selection
- Electronic data capture (EDC) system evaluation
Site Management
Domestic & International
Comprehensive oversight of investigative sites — ensuring accountability, compliance, and staff excellence across all geographies.
Best For
What's Included
- Site selection, qualification, and activation
- Investigator and coordinator mentorship programs
- Protocol training and site staff competency assessment
- Enrollment performance tracking and optimization
- International site management with local regulatory compliance
- Investigational product (IP) accountability oversight
- Regulatory document collection and maintenance
- Site closeout procedures
Onsite & Remote Monitoring
Routine & Risk-Based
Flexible monitoring programs — from traditional onsite visits to modern risk-based monitoring — protecting data integrity and patient safety.
Best For
What's Included
- Source data verification (SDV) and source data review (SDR)
- Risk-based monitoring (RBM) plan development
- Routine monitoring visit reports
- Protocol deviation identification and tracking
- Informed consent process review
- Investigational product management verification
- Remote monitoring using EDC and eTMF platforms
- CAPA (Corrective and Preventive Action) follow-up
Audit & Audit Preparedness
For-Cause & Routine
Proactive audit programs and FDA inspection readiness training to keep your study prepared for regulatory scrutiny at all times.
Best For
What's Included
- GCP compliance audits (site and sponsor)
- For-cause audit support and representation
- FDA inspection readiness assessments
- Mock FDA audit simulations
- Warning letter and Form 483 response strategy
- eTMF and paper TMF audit support
- Vendor/CRO qualification audits
- Post-audit corrective action plan development
Research Staff Training
GCP, Protocol-Specific & Clinical
Comprehensive training programs designed to build research staff competency and a culture of compliance — from GCP fundamentals to disease-specific clinical education.
Best For
What's Included
- ICH-GCP / FDA GCP training (21 CFR Parts 50, 54, 56, 312)
- Patient welfare and rights education
- Protocol-specific training modules
- General medical and therapeutic area knowledge
- Data integrity and electronic records training (21 CFR Part 11)
- Informed consent process training
- Adverse event recognition and reporting
- Role-specific training: PI, sub-I, coordinator, pharmacist
Quality Assurance
Systems & Process Improvement
Building quality management systems that embed compliance into daily research operations rather than treating it as an afterthought.
Best For
What's Included
- Quality Management System (QMS) development
- SOP creation, review, and version control systems
- Quality metrics dashboards and KPI tracking
- Internal quality audits and continuous improvement programs
- Data quality monitoring and trend analysis
- CAPA program management
- Regulatory intelligence updates and SOP alignment
- Quality agreements with vendors and sites
Need a Custom Combination of Services?
Most of our clients benefit from a tailored package. Submit your study details and we'll design the right support structure.
Get a Custom Proposal