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Consultation
GIR provides a myriad of consulting services for your clinical trial needs. We have been helping to shape the clinical trial landscape through the following services.
These services cover the clinical trial process from concept to close.
​Contact Us today to see how GIR can contribute to the success of your next project.​​
Bid Defense Preparation and Attendance​
Ensure the success of your next proposal with GIR's expert bid defense preparation. Our team specializes in helping biotech companies present persuasive, data-driven proposals that meet regulatory standards and exceed sponsor expectations. With deep expertise in clinical trial processes and cutting-edge technologies, we provide tailored solutions that maximize your chances of securing a successful outcome.
Charter development​
Streamline your clinical trial process with expertly crafted clinical trial charters. Our consulting services focus on developing clear, compliant, and comprehensive charters that define roles, responsibilities, and objectives for your trial team. With deep knowledge of FDA regulations, ICH-GCP guidelines, and current industry trends, we ensure your charter meets the highest standards for oversight and operational efficiency. GIR helps you design a charter that aligns with regulatory requirements and enhances trial management, minimizing risks and improving outcomes. Let us help you lay the foundation for a successful trial with a robust, well-defined charter.
SOP Development
Achieve operational excellence in your clinical trials with customized SOP (Standard Operating Procedure) development. We work closely with your team to develop SOPs tailored to your specific trial needs, covering everything from patient recruitment and data management to safety reporting and monitoring. By reducing process variability and improving quality control, our SOPs enable consistent trial execution and regulatory readiness. Let us help you implement SOPs that drive efficiency, compliance, and superior trial outcomes across all trial phases.
Trial Design (end points, thresholds, etc)
Maximize the success of your clinical trials with expert clinical trial design consulting. Our team specializes in crafting innovative, scientifically sound, and regulatory-compliant trial designs that meet the unique needs of your study. We provide strategic insights on endpoint selection, patient population targeting, randomization methods, and statistical analysis plans, ensuring your trial is both efficient and effective. With deep expertise in the latest industry trends and FDA requirements, we help you balance scientific rigor with operational feasibility, optimizing your trial for faster approvals and better outcomes. Whether you’re designing a Phase I safety study or a large-scale Phase III trial, we ensure your trial is set up for success from the ground up.
Training
Our comprehensive clinical trial training services are designed to equip your team with the expertise needed to excel in the complex world of clinical research. We offer tailored training programs that cover every aspect of clinical trials, from trial design and planning to calibration sessions and in-depth protocol discussions. Our experienced trainers guide your team through best practices, regulatory compliance, and advanced methodologies to ensure your clinical trial processes are streamlined, accurate, and effective. Whether you're initiating a new study or refining existing protocols, we provide the insights and tools to elevate your research to the next level.