At EpiSmart Science Vector, we are dedicated to supporting the advancement of medical science through robust clinical research services and infrastructure. Our comprehensive offerings are designed to facilitate every phase of your clinical trial, ensuring accuracy, efficiency, and compliance with regulatory standards.
Expert Consultation and Design
Clinical research is the backbone of medical innovation, providing critical insights that drive the development of new treatments and therapies. Our team of experts begins by offering in-depth consultation to understand your specific research objectives and requirements. We collaborate closely with you to design a trial that meets your scientific goals while adhering to ethical standards and regulatory guidelines.
Regulatory Compliance and Ethical Standards
Navigating the complex landscape of regulatory requirements is crucial for the success of any clinical trial. Our experienced professionals handle all aspects of regulatory compliance, from submitting documentation to obtaining approvals from ethical review boards. We ensure that your trial adheres to local and international regulations, protecting the integrity of your research and the safety of participants.
Site Selection and Preparation
Selecting the right sites for your clinical trial is vital for gathering reliable data. We assist in identifying and preparing trial sites that meet your specific needs. Our thorough site assessment process ensures that each location has the necessary infrastructure, equipment, and qualified staff to conduct the trial effectively. We also provide comprehensive training to site personnel, ensuring they are well-versed in trial protocols and good clinical practice (GCP) guidelines.
Advanced Data Management Systems
Efficient data management is crucial for the success of clinical research. Our state-of-the-art electronic data capture (EDC) systems streamline data collection, storage, and analysis. These systems are compliant with regulatory standards such as 21 CFR Part 11, ensuring data integrity and security. Our team trains site staff on using these systems, promoting accurate and efficient data entry.
Patient Recruitment and Engagement
Successful clinical trials depend on effective patient recruitment and engagement. We develop tailored recruitment strategies to reach your target population, utilizing various channels such as digital media, community outreach, and partnerships with healthcare providers. Our patient-centric approach ensures that participants are well-informed, engaged, and retained throughout the trial.
Quality Assurance and Monitoring
Maintaining the highest standards of quality is our priority. We implement rigorous quality assurance processes, including regular monitoring visits and audits. Our quality management plan addresses any issues promptly, ensuring compliance with trial protocols and safeguarding data integrity. Continuous monitoring allows us to identify and resolve potential problems early, maintaining the trial’s validity and reliability.
Data Analysis and Reporting
Accurate data analysis is essential for drawing meaningful conclusions from your clinical trial. Our team of biostatisticians and data analysts utilizes advanced statistical methods to interpret the collected data. We provide comprehensive reports that detail the findings and offer actionable insights, helping you make informed decisions about your research.
Customized Solutions for Your Research Needs
Every clinical trial is unique, and we pride ourselves on offering customized solutions tailored to your specific needs. Whether you are conducting a small pilot study or a large-scale multi-center trial, our flexible approach ensures that we can support your research at every stage.
At EpiSmart Science Vector, we are committed to advancing medical science by providing exceptional clinical research services and infrastructure. Partner with us to ensure the success of your clinical trials and contribute to the development of groundbreaking medical treatments. Contact us today to learn more about how we can support your clinical research endeavors.
his document outlines the tasks and responsibilities for the service provider responsible for establishing the infrastructure to run a randomized clinical trial (RCT). The service provider is expected to ensure high-quality, accurate, and compliant execution of the RCT infrastructure setup.
Scope of Work
Initial Consultation and Requirement Gathering
- Conduct initial meetings with the client to understand the specific objectives, scope, and requirements of the RCT.
- Identify key stakeholders, trial phases, and expected outcomes.
- Develop a clear understanding of the expected deliverables and timelines.
Regulatory Compliance and Approvals
- Ensure compliance with all relevant regulatory requirements (e.g., FDA, EMA, local IRBs).
- Prepare and submit all necessary documentation for regulatory approvals.
- Obtain ethical clearances from institutional review boards (IRBs).
Site Selection and Preparation
- Identify and select appropriate trial sites based on the trial’s requirements and target population.
- Assess site capabilities, including facilities, equipment, and staff qualifications.
- Prepare sites by ensuring they meet all regulatory and trial-specific requirements.
Infrastructure Setup
- Establish the necessary physical infrastructure at each trial site, including secure storage for trial materials and data.
- Set up essential equipment and technology, including clinical and laboratory equipment.
- Ensure availability of emergency medical facilities and equipment as required.
Data Management System
- Implement a robust electronic data capture (EDC) system for secure and efficient data collection.
- Ensure the EDC system complies with regulatory standards such as 21 CFR Part 11.
- Train site staff on the use of the EDC system and data entry protocols.
Patient Recruitment and Enrollment
- Develop a comprehensive patient recruitment strategy tailored to the target population.
- Create and distribute recruitment materials, including informed consent documents.
- Establish procedures for patient screening, enrollment, and randomization.
Staff Training and Management
- Provide training for site staff on trial protocols, good clinical practice (GCP), and regulatory compliance.
- Ensure continuous education and training throughout the trial.
- Implement a system for ongoing support and communication with site staff.
Supply Chain Management
- Coordinate the procurement and distribution of trial materials, including investigational products, placebos, and necessary medical supplies.
- Establish secure and efficient logistics for the transportation and storage of trial materials.
- Monitor supply levels and manage inventory to prevent shortages or delays.
Quality Assurance and Monitoring
- Develop a comprehensive quality management plan to ensure compliance with trial protocols and regulatory requirements.
- Conduct regular site monitoring visits to ensure adherence to trial protocols and data integrity.
- Implement corrective and preventive actions (CAPAs) to address any issues identified during monitoring.
Data Security and Confidentiality
- Ensure all trial data is securely stored and access is restricted to authorized personnel.
- Implement data encryption and other security measures to protect patient confidentiality.
- Ensure compliance with data privacy regulations such as GDPR and HIPAA.
Trial Documentation and Reporting
- Maintain comprehensive and accurate trial documentation, including case report forms (CRFs), monitoring reports, and audit trails.
- Prepare and submit regular progress reports to the client and regulatory authorities.
- Ensure timely and accurate reporting of adverse events and protocol deviations.
Continuous Improvement
- Seek feedback from trial sites and stakeholders to identify areas for improvement.
- Stay updated with the latest developments in clinical trial management and infrastructure.
- Provide training and development opportunities for the team to enhance their skills.
Deliverables
- Initial consultation report outlining client needs and proposed approach.
- Regulatory and ethical approval documentation.
- Site selection and preparation of report.
- Infrastructure setup and readiness report.
- Data management system implementation and training documentation.
- Patient recruitment strategy and materials.
- Staff training records and ongoing support plan.
- Supply chain management plan and inventory logs.
- Quality assurance and monitoring reports.
- Data security and confidentiality protocols.
- Comprehensive trial documentation and regular progress reports.
Timeline
- Initial consultation and requirement gathering: 2-3 weeks
- Regulatory compliance and approvals: 4-8 weeks
- Site selection and preparation: 4-6 weeks
- Infrastructure setup: 3-5 weeks
- Data management system implementation: 2-4 weeks
- Patient recruitment and enrollment: 6-12 weeks (ongoing as needed)
- Staff training and management: 2-3 weeks (ongoing support)
- Supply chain management: Ongoing throughout trial
- Quality assurance and monitoring: Ongoing throughout trial
- Data security and confidentiality: Ongoing throughout trial
- Trial documentation and reporting: Ongoing throughout trial
Responsibilities
- Service Provider: Responsible for executing all tasks as outlined, maintaining communication with the client, ensuring quality and accuracy, and delivering all outputs within the agreed timeline.
- Client: Responsible for providing access to necessary information, participating in consultations, and providing timely feedback.
Communication
- Regular status updates to the client (weekly or as agreed).
- Immediate communication of any issues or delays.
- Final presentation meeting to discuss infrastructure setup and readiness.
Payment Terms
- Payment schedule based on milestones (e.g., upon completion of regulatory approvals, site preparation, infrastructure setup).
- Detailed invoice provided at each milestone.
- Final payment upon satisfactory completion of all tasks and deliverables.
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