Full-Service Solution
AGCR's Full-Service Solution propels your late-phase trials into commercial success. Our expert team manages efficacy and safety data, generates vital real-world evidence, and provides strategic support for pricing agreements. With a commitment to excellence, our regulatory, clinical, and medical affairs specialists ensure your success in this critical phase. Trust AGCR for a seamless transition to market leadership.
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Strategic Clinical Development Consulting
Elevate your clinical development journey with AGCR's Strategic Consulting Excellence. Start early, ensuring precision from the outset. Navigate a dynamic landscape with agility and expertise. Overcome hurdles seamlessly with our seasoned strategists and problem-solvers dedicated to clinical development excellence.
At AGCR, we stand out as your trusted partner, drawing from extensive experience in aiding pharmaceutical, biotechnology, and medical device firms. Our proactive, forward-thinking approach enhances efficiency, providing clarity on pivotal decisions and timelines throughout novel therapy development. From IND planning to regulatory approval, our expert regulatory, clinical, medical, and statistical consultants deliver high-level strategic consulting services. Choose AGCR for a strategic edge in your clinical development journey.
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Regulatory Affairs
At AGCR, we unlock regulatory success. Our seasoned experts serve as strategic navigators, seamlessly guiding you through complex regulatory pathways to secure essential approvals and ensure unwavering compliance. Redefining excellence in regulatory affairs, we decode the landscape, offering a clear roadmap for success. Trust us to transform challenges into opportunities and safeguard your journey towards regulatory approval with precision and expertise.
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Site Support Services
Discover the power of our extensive network of investigator’s sites, delivering unparalleled support for patient recruitment and data collection. With our dedicated team and robust infrastructure, we ensure seamless operations and optimal performance. Trust us to enhance your research capabilities and drive success in every aspect of clinical research services.
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Clinical Trial Management
We provide end-to-end clinical trial management services, from protocol design to regulatory submission and study archival.
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Data Management
We furnish streamline data management by automating extraction, integrating diverse datasets, and ensuring real-time monitoring. Predictive analytics and natural language processing enhance decision-making, quality control, and risk management. This will improve patient recruitment, ensuring efficient, accurate, and timely clinical research data collection.
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Pharmacovigilance and Drug Safety
At AGCR, we redefine Pharmacovigilance with system excellence. Our adept team, powered by cutting-edge technology, ensures rigorous monitoring and swift reporting of adverse events. Experience the future of patient safety as we integrate robust system to set new standards in pharmaceutical integrity. Join us in shaping a safer, healthier tomorrow.
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Non-Affiliated Audits
Our commitment to transparency and credibility is underscored by Non-Affiliated Audits, encompassing Clinical Trial, Risk-Based Monitoring, Project Management, GCP, and BA/BE Study Monitoring. Independently conducted, these rigorous evaluations offer invaluable insights, fostering continuous enhancement in our clinical research services. We prioritize accountability, assuring clients of the reliability and excellence in every facet of our operations. Partner with AGCR for quality-driven practices and a steadfast dedication to continuous improvement in clinical research.
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Medical Writing
AGCR takes pride in delivering integrated Medical Writing Solutions tailored to your research landscape. Our seasoned team specializes in diverse therapeutic areas, including vaccines and devices. Collaborating seamlessly with biostatistical, pharmacovigilance, project management, and clinical data management units, we ensure the production of precise and timely documents that adhere to the highest scientific and ethical standards. AGCR's proficiency spans Regulatory Medical Writing and extends to crafting Drug Safety and Risk Management Reports, championing regulatory compliance and optimizing the drug development process for unparalleled success.
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Decentralized Clinical Trial (DCT)
At Akshar Global Clinical Research (AGCR), we proudly extend our specialized services in Decentralized Clinical Trials (DCT), catering to the unique demands of our clients. Whether opting for a hybrid or fully virtual model, we are equipped to tailor our solutions to meet your specific requirements.
Our experienced team at AGCR is dedicated to providing comprehensive support throughout your trials. If you find yourself in need of assistance or contemplating the suitability of a DCT model for your project, we encourage you to connect with our experts today. Take the first step towards optimizing your clinical research by reaching out for a personalized consultation with AGCR.
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Biostatistics
At Akshar Global Clinical Research (AGCR), our expert Biostatisticians are dedicated to ensuring the success of your clinical study. From precise study design to meticulous oversight throughout the trial, we calculate efficient sample sizes, choose optimal statistical methods, and guarantee accurate data collection. Trust AGCR to deliver clear and accurate statistical analyses, aligning seamlessly with regulatory expectations for a comprehensive and successful study review.
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Functional Service Provider
Discover unparalleled expertise with AGCR's Functional Service Provider (FSP) team. Our FSP services encompass vital roles across clinical development disciplines, offering biopharmaceutical companies access to highly trained experts precisely when and where needed. At AGCR, we specialize in scaling clinical trials, expediting timelines, and optimizing efficiency throughout the development process. Join our commitment to excellence, shaping the future of therapies with AGCR's FSP services – where expertise meets impact.
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These services reflect our commitment to providing sponsors with a comprehensive suite of clinical research support, tailored to their specific needs. Our dedicated team of professionals works diligently to ensure the successful execution of clinical trials and the generation of high-quality data and reports.