Operational clinical excellence for successful studies in America
Clinical execution solutions for quality data and reliable results
The decision to select a CRO boils down to one fundamental question:
Can we execute the study efficiently, collect high-quality data, and protect patient safety, all within the established timeframe and budget?
Our proposal focuses on the core of clinical research: operational excellence in execution.
We present a model that guarantees the integrity of your data and accelerates the delivery of reliable results in the Americas.
Clinical Performance
Accelerated Site Selection and Activation
Investigator Database: We maintain a relational database of investigators in the Americas for specific therapies.
Clinical Feasibility Assessment: We evaluate not only recruitment capacity but also the team's experience with the therapy, the availability of appropriate diagnostic equipment, and the ability to manage complex protocols.
Rapid Activation: Our specialized local teams manage contracts and Ethics Committee approvals concurrently, reducing activation time by 30% compared to the market average.
Design and Strategic Planning of the Study
Optimized Protocols: Our leading physicians and experimental design experts collaborate with you to refine the protocol, ensuring it is feasible, ethical, and efficient for implementation in diverse clinical settings across the Americas.
Comprehensive Operational Plan (Manuals, Guidelines, Data Management Plan): We don't just develop documents; we create the tools that will guarantee seamless standardization across all sites. This includes:
Quality Management Plan (QMP)
Data Management Plan (DMP)
Centralized and/or Risk Monitoring Plan
Study-specific procedure manuals.
High-Performance, Risk-Based Clinical Monitoring (RBQM)
Senior Clinical Monitors: With an average of 8+ years of experience and therapeutic specialization.
Implementation of RBQM (Risk-Based Quality Management): We go beyond 100% data source monitoring (DSV). We use a centralized platform to:
Identify risks and deviations to detect failures in the informed consent process and critical protocol deviations.
Direct on-site monitoring efforts toward the highest-risk sites and processes, optimizing costs and improving quality.
Generate KRI (Key Risk Indicator) reports for proactive decision-making.
Core Clinical Capabilities: Depth and Specialization
Pharmacovigilance Safety and Adverse Event Management (AE)
Processes Compliant with E2B (R3) and EudraVigilance: Pharmacovigilance reporting system prepared for regulatory compliance.
24/7 AE Management: We have partners in pharmacovigilance centers with trained medical personnel available 24/7 to receive, process, and report Serious Adverse Events (SAE) to the appropriate authorities within the required regulatory timeframes.
Data Safety and Monitoring Committee (DSMB): We manage the complete logistics, member selection, and operational support for independent DSMB committees.
Commitment to quality and compliance
Medical and Scientific Management
Dedicated Study Physicians: We assign a physician with expertise in your therapeutic area to answer medical inquiries from the sites, review SAEs, and ensure consistent medical interpretation of the protocol.
Clinical Operations Lead (CL): A senior CL will act as the conductor of your study, ensuring that all clinical components (monitoring, data, safety, logistics) are perfectly synchronized.
First-Line Data Management and Biostatistics
From-the-Source Data Management: Our EDC designers work with researchers to create intuitive CRFs that minimize errors from the entry point.
Scheduled Edit Checks for immediate validation.
Statistical Analysis Plans (SAP) developed from the outset, ensuring that the captured data will answer the study's clinical questions.
Integrated Biometric Team: Biostatisticians and programmers work closely with the data management team, guaranteeing a seamless workflow from the clean database to the final report.
Quality isn't a department; it's a result of our process.
Comprehensive Quality Management System (QMS): Our QMS is based on GCP-ICH and is audited.
Proactive Internal Audits: We conduct routine internal audits of high-risk processes and sites, not just in response to problems.
Regulatory and Sponsor Audit Preparation: We help you prepare your sites and provide comprehensive support during inspections by authorities such as the FDA, ANVISA, or COFEPRIS.
Tangible Clinical Advantages for Your Investment
Slow and uneven recruitment.
Inconsistent and low-quality data.
Inefficient handling of security incidents.
Lack of standardization across countries.
Recruitment strategy with a local focus and pre-screening of potential patients.
Risk-based monitoring (RBQM) + EDC with advanced edit checks + senior monitors.
24/7 Pharmacovigilance Center and E2B processes.
Standardized manuals and training, with local teams that understand the specific needs of each area.
Greater likelihood of meeting study recruitment and timeline targets.
Clean and reliable data, fewer protocol deviations, and a lower risk of regulatory rejection.
Absolute regulatory compliance in safety and robust patient protection.
Consistent execution and comparable data across all sites in the Americas.
Operational Challenge Our Clinical Solution Benefit for You
