Clinical Development
At IntegriTrials, we provide comprehensive Clinical Development Services designed to accelerate your drug and device development programs from early-phase trials to post-marketing studies. Our certified professionals, proven methodologies, and flexible delivery models ensure your studies are conducted with precision, speed, and regulatory compliance.
01
Clinical Operations Management
Lay the groundwork for successful clinical trials with our expert planning and strategy services. We provide comprehensive support from concept to execution, including meticulous protocol design support, insightful feasibility assessment & country/site selection, and clear regulatory pathway guidance. Our strategic clinical development planning ensures your trials are optimized for efficiency, compliance, and ultimately, groundbreaking results.
02
Data Management & Biostatistics
Transform your raw clinical data into actionable insights with our expert Data Management & Biostatistics services. We provide end-to-end solutions, encompassing meticulous EDC setup and data cleaning to ensure accuracy from the source. Our team specializes in comprehensive statistical analysis planning and generating CDISC-compliant datasets, guaranteeing your data is robust, analysis-ready, and meets all regulatory requirements for reliable and publishable results.
03
Medical Monitoring & Safety Oversight
Ensure the paramount safety of your clinical trial participants and the integrity of your data. We provide comprehensive medical monitoring and safety oversight services, including in-depth medical review of data, meticulous SAE (Serious Adverse Event) and AE (Adverse Event) management, and seamless pharmacovigilance coordination. Our proactive approach and medical expertise help identify and mitigate risks, ensuring your studies meet the highest safety and regulatory standards.
04
Project and Program Management
Drive your clinical trials to successful completion with our expert project and program management. We offer end-to-end coordination, meticulously handling every detail from initial planning to study close-out. Our services include rigorous timeline and milestone tracking, diligent budget control and vendor oversight, and proactive sponsor communication and reporting, ensuring your research goals are met efficiently and transparently.
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