Boutique Expertise, Scaled for Your Needs
Services
We understand that every project is unique, which is why we offer tailored solutions to meet your specific needs—whether you’re conducting preclinical studies, navigating regulatory hurdles, or advancing clinical trials. We provide end-to-end support with a personalized touch, ensuring your goals are met efficiently, cost-effectively, and with the utmost expertise.
Let us help bring your vision to life, no matter the size or scope of your project.
Clinical Study Design
We provide comprehensive clinical trial protocol development for both regulated and non-regulated environments. Our team works closely with biostatisticians, clinical trialists, regulatory professionals, quality assurance, reimbursement, and marketing specialists to create effective protocols that align with corporate goals, market demands, and regulatory standards.
Protocol Development
Crafting tailored study protocols with a focus on regulatory, clinical, and market objectives.
Biostatistics
Designing robust statistical plans to analyze and interpret data with precision.
Trial Design Strategy
Identifying study phases, endpoints, and patient populations to optimize success.
Regulatory Strategy Alignment
Ensuring study design meets FDA, EMA, and global regulatory standards.
Feasibility Assessments
Evaluating study and site feasibility based on patient access, competitive trials, and investigator capabilities.
Endpoint Development & Validation
Defining and validating clinical, functional, and patient-reported endpoints for meaningful outcomes.
Study Feasibility & Site Selection Guidance
Recommending high-performing sites and investigators for optimized trial execution.
Adaptive & Innovative Trial Design
Leveraging adaptive, decentralized, and hybrid trial models for greater efficiency and patient access.
Clinical Operations
Site Selection & Qualification
Site Training Management
Provide full oversight, including startup, training, and monitoring.
Patient Recruitment & Retention
Develop strategies to ensure diverse and on-time enrollment.
Data Management
Implementing EDC systems for clean, real-time data collection.
Regulatory and Quality Management System (QMS)
We guide you through the intricate regulatory landscape, ensuring FDA, ISO, and ICH compliance while building strong quality systems. Our expert support spans from early development to post-market compliance, helping clients accelerate approvals, manage risks, and uphold the highest standards of quality and regulatory adherence.
Regulatory Submissions & Compliance
Managing FDA, ICH, and ISO submissions, including 510(k), IDE, PMA, IND, and CE Mark applications.
Regulatory Strategy & Pathway Development
Crafting customized roadmaps to navigate global regulatory requirements.
Clinical Trial Regulatory Support
Providing submission and compliance support throughout the trial lifecycle.
Quality Management Systems (QMS) Development
Establishing and overseeing tailored QMS solutions to ensure compliance and efficiency.
Audits & Inspections
Conducting pre-audit site readiness assessments, mock inspections, and audit remediation.
Gap Analysis & Risk Assessments
Identifying regulatory and quality system gaps to proactively mitigate compliance risks.
Post-Market Surveillance & Compliance
Developing PMS plans, managing post-market reporting, and ensuring ongoing regulatory adherence.
Supplier & Vendor Audits
Evaluating third-party compliance with FDA, ISO, and ICH standards.
Corrective & Preventive Action (CAPA) Implementation
Implementing CAPA programs to address and prevent compliance issues.
Regulatory Intelligence & Policy Monitoring
Keeping up with evolving regulations to maintain proactive compliance strategies.
Risk Management
Proactively identifying and mitigating risks is at the core of our trial operations. By integrating risk-based methodologies into every phase of clinical research, we enhance compliance, safeguard patient safety, and ensure study integrity—minimizing delays and optimizing outcomes.
Real-Time Risk Assessment
Implementing continuous risk assessment frameworks to identify and address potential study challenges before they escalate.
Site Audits & Inspection Readiness
Conducting proactive site audits to ensure GCP compliance, regulatory preparedness, and protocol adherence.
Trial Monitoring & Risk-Based Monitoring (RBM)
Utilizing data-driven monitoring approaches to optimize trial oversight, focusing on high-risk areas to enhance efficiency and compliance.
Regulatory & Compliance Risk Management
Assessing regulatory risks and implementing mitigation strategies to maintain compliance across global markets.
Patient Safety & Data Integrity Oversight
Ensuring adverse event monitoring, protocol compliance, and high-quality data collection to protect patients and study credibility.
Corrective & Preventive Action (CAPA) Implementation
Developing and executing CAPA plans to address deviations and enhance trial robustness.
Evidence Generation
Transforming clinical trial data into actionable insights that drive regulatory approval, market adoption, and commercial success. Our expertise ensures that data is not only collected but strategically leveraged to demonstrate clinical and economic value.
Biostatistics & Data Analysis
Applying advanced statistical methodologies to generate clear, robust, and meaningful insights from clinical trial data.
Publications & Presentations
Translating trial outcomes into high-impact, peer-reviewed manuscripts, white papers, and conference presentations.
Market Access Support
Guiding clients through the complexities of reimbursement, health economics, and payer engagement to accelerate market adoption.
Real-World Evidence (RWE) Generation
Designing and executing studies that validate clinical effectiveness and long-term product performance.
Health Economics & Outcomes Research (HEOR)
Demonstrating cost-effectiveness, quality-of-life benefits, and the economic value of medical innovations.
Regulatory & Payer Dossier Development
Crafting evidence-based dossiers that support regulatory filings and reimbursement applications.
Competitive Landscape & Benchmarking Analysis
Providing data-driven insights into competitor positioning and industry trends to refine market strategies.