Site Management and Communications
Active project management with continuous tracking and communication about project status.
Data and Safety Monitoring
Medical monitoring, coordination of DSMBs, on-site and remote data monitoring, eCRF and EDC support.
Enrollment and Retention Strategy
Continuous planning for recruitment and enrollment, retention plans, and active monitoring of site progress.
Continuous support and tracking for lab, imaging, eConsent, ePRO, EDC, IRT, and other services.
Ongoing Regulatory Support
Submissions management for protocol amendments, recruitment materials, site continuing review, and safety reporting.
Our Featured Services
We can provide full-service clinical trial management or individual services to meet your needs. We want you to complete your trial on schedule and under budget so you can move on to the next step in your approval process.
Recruitment and Retention Planning
We collaborate closely with trial sites, employing targeted strategies to identify and retain suitable patients. We use active monitoring and rapid adaptation to ensure enrollment targets are met.
Let our experts design your monitoring plan. Our risk-based approach focuses resources where they’re needed most, improving patient safety and trial outcomes while reducing costs.
Our outstanding project managers are dedicated to your project, optimizing timelines, budgets, and study quality, ensuring the successful execution of your trial.
We offer an EDC and IRT platform designed to be easy to implement, monitor, and export data. Our team of statisticians can design and perform interim analyses to ensure your trial in on track.
Specialty Services and Consultation
We love a challenge! No project is too complex or too unique for our team. We take on specialty projects of all sizes to get you through project roadblocks and on track for successful trial completion.
The Value of Active Project Management
Identifying and adapting to underperformance in a clinical trial's progress at the midpoint is invaluable. It allows for timely intervention when recruitment lags, protocol amendments are necessary, or unexpected safety concerns arise. This proactive approach minimizes the risk of trial failure, reduces costs, and accelerates development timelines.
Moreover, it upholds ethical standards by ensuring patient safety and data integrity. Collaborative efforts between sponsors, CROs, and investigators, guided by real-time data analysis and risk assessment, can steer the trial back on course. In a dynamic clinical landscape, this adaptability is crucial for successful and ethical drug development.
Frequently Asked Questions
There are many aspects of clinical trials that need to be actively managed to achieve successful outcomes. Here are some common questions about clinical trial management services.
Clinical trial management services encompass the planning, coordination, and execution of all aspects of a clinical trial, ensuring it runs efficiently, ethically, and within budget.
Patient Recruitment and Retention: Ensuring a steady flow of eligible participants and retaining them throughout the trial is a persistent challenge. Strategies to enhance patient engagement and retention are crucial.
Data Quality and Integrity: Maintaining high-quality, error-free data collection and management is a fundamental aspect of clinical trials. Improvements in data monitoring and quality control measures are often needed.
Cross-Functional Collaboration: Effective collaboration among various stakeholders, including researchers, clinicians, data managers, and sponsors, can sometimes be lacking. Streamlining communication and cooperation is essential for smooth trial operations.
Reducing the budget for clinical trials while maintaining quality and compliance is a critical challenge. Here are three of the most commonly used strategies:
Decentralized Clinical Trials (DCTs): Leveraging remote technologies, DCTs reduce costs by allowing patients to participate from home, minimizing the need for physical sites and lowering patient travel expenses.
Real-World Evidence (RWE) Integration: By incorporating RWE from electronic health records, trials can reduce data collection costs and gain insights into real-world drug performance, potentially shortening traditional trial durations
Data Analytics and Artificial Intelligence (AI): Advanced analytics and AI can optimize trial design, recruitment, and data analysis. We can help you in identifying optimal sites and patient populations, accelerating analysis, and improving cost-effectiveness while maintaining research quality.
Patient recruitment and retention strategies are paramount in clinical trial management. If you prioritize just one service, consider partnering with a CRO experienced in site selection and patient recruitment. This promotes a steady flow of eligible participants, enhances retention rates, and ultimately contributes to the trial's success.