Clinical operations
Clinical operations play a pivotal role in the success of all studies,
from start-up to close-out. Our highly skilled clinical operations teams are dedicated to ensuring meticulous planning, execution, patient safety, and data quality while promoting effective communication between study sites and sponsors. With a focus on collaborative planning and operational excellence, our clinical trial managers provide strong leadership throughout the entire process. Clinical research associates work closely with your team, offering protocol training, building robust site relationships, and ensuring compliance at every step.
Our extensive network of clinical trial experts across India, combined with established partnerships in Europe, the USA, South Africa, and Australia, guarantees global consistency and support. We adhere to the highest standards of quality, ensuring compliance with ICH-GCP guidelines and other regulatory frameworks, regardless of where your clinical trials are conducted. Whether you need assistance managing an increased workload or seek to design a comprehensive clinical program, our experienced team is ready to collaborate with you, creating tailored solutions that align with your unique needs.
To ensure the highest level of compliance and quality, we follow industry-leading standards and regulations across all phases of clinical trials, including:
- ◼ ICH-GCP (International Council for Harmonization - Good Clinical Practice)
- ◼ FDA regulations (21 CFR)
- ◼ ISO 14155 (Clinical investigations of medical devices)
- ◼ EU Clinical Trials Regulation (536/2014)
These industry standards form the backbone of our approach, allowing us to deliver exceptional results while maintaining the integrity and reliability of your clinical program on a global scale.
Whether helping with an overload of work or designing a full-service clinical program, our experienced, knowledgeable team is ready to partner with you to develop a program customized to your needs.
The components of clinical operations include the following:
- • Patient recruitment and retention strategies
- • Site management and monitoring
- • Data collection and review
- • Source document verification (SDV)
- • Query resolution and issue management
- • Compliance with regulatory requirements
- • Investigational product accountability
- • Study closure and final reporting
- 1. Study Design and Protocol Development:
◼ Creating the study plan, including objectives, methodology, and eligibility criteria. - 2. Site Selection and Management:
◼ Identifying and selecting appropriate study sites, negotiating contracts, and managing relationships. - 3. Regulatory Compliance:
◼ Ensuring adherence to local and international regulations (e.g., ICH-GCP, FDA, EMA). - 4. Patient Recruitment and Retention:
◼ Developing strategies for recruiting participants and maintaining engagement throughout the study. - 5. Training and Support:
◼ Providing training for site staff on study protocols, data collection, and compliance. - 6. Data Management:
◼ Collecting, monitoring, and analyzing study data to ensure accuracy and integrity. - 7. Safety Monitoring:
◼ Overseeing adverse event reporting and ensuring patient safety throughout the trial. - 8. Quality Assurance:
◼ Implementing quality control measures and conducting audits to ensure compliance and data integrity. - 9. Clinical Trial Monitoring:
◼ Regularly monitoring sites to ensure adherence to protocols, regulatory requirements, and data accuracy. - 10. Project Management:
◼ Coordinating timelines, budgets, and resources to ensure successful trial execution. - 11. Reporting and Documentation:
◼ Preparing reports, managing documentation, and ensuring compliance with regulatory requirements. - 12. Close-out Activities:
◼ Finalizing study activities, including data analysis, reporting results, and archiving study materials.
