Seamless Site Operations. Reliable Trial Outcomes

AQSite delivers end-to-end site management support—from feasibility to close-out—ensuring every study is conducted with operational precision, ethical oversight, and patient-centric focus. Our expertise bridges sponsors, investigators, and participants to drive trial success.

Our Site Management Experience

With over 13 years of hands-on experience in clinical research industry and clinical site operations, AQSite has consistently delivered high-quality, efficiently managed clinical trials across diverse therapeutic areas. Our team ensures smooth coordination between investigators, ethics committees, and sponsors through proactive planning, continuous communication, and technology-driven oversight. We have successfully supported and Audited over 100+ studies in recent years, spanning areas such as oncology, respiratory diseases, nephrology, gastroenterology, infectious diseases, cardiology, and more, reflecting our expertise in managing complex, multi-site clinical programs. Our strong track record in subject recruitment, site activation, regulatory documentation, and on-site quality oversight enables us to deliver streamlined site operations, faster study start-ups, and consistent performance across locations. At AQSite, we take pride in our operational excellence, collaborative approach, and unwavering commitment to quality, ensuring every trial site performs to the highest standards and drives successful outcomes for every sponsor.

Core activities include:

Site Feasibility & Selection

Evaluate potential trial sites for capabilities, patient population, past performance, and regulatory readiness to ensure optimal site selection.

Regulatory & Ethics Committee Coordination

Manage submissions, approvals, and ongoing communication with regulatory authorities and ethics committees to maintain compliance and timely trial initiation.

Site Activation & Start-Up Management

Oversee contracts, budgets, site initiation visits, and logistics to ensure sites are fully prepared for study conduct.

Patient Recruitment & Retention Strategies

Implement targeted recruitment plans, leveraging volunteer and patient databases, outreach campaigns, and optimized screening to meet enrollment goals efficiently.

Site Monitoring & Performance Oversight

Track and evaluate site performance, adherence to protocol, recruitment progress, and operational metrics through structured oversight and monitoring visits.

Protocol & SOP Compliance Management

Ensure all site personnel follow study protocols and standard operating procedures, reducing deviations and improving data quality.

Investigator Training & Engagement

Conduct training sessions, workshops, and continuous support to investigators and site staff, enhancing protocol compliance and operational efficiency.

Risk-Based Site Oversight & CAPA Management

Identify potential risks proactively and implement corrective and preventive actions to minimize impact on trial timelines and data integrity.

Real-Time Reporting & Dashboard Updates

Provide sponsors with centralized dashboards for enrollment status, site performance, protocol adherence, and actionable insights.

Documentation & Data Management

Ensure accurate, complete, and audit-ready trial records through standardized documentation practices and digital management systems.

Solution:

>Accelerated Site Initiation: AQSite streamlines feasibility assessments, regulatory submissions, and site activation through proactive planning and standardized workflows, reducing start-up timelines and enabling faster trial initiation.
>Targeted Patient Recruitment: Our team implements strategic recruitment plans using an extensive volunteer and patient database, site-specific outreach, and optimized screening procedures to meet enrollment targets efficiently.
>Enhanced Site Performance Oversight: Through structured monitoring and performance tracking, AQSite ensures consistent adherence to protocols, high-quality data collection, and optimized site operations across all trial locations.
>Improved Communication and Coordination: Using digital tools and centralized reporting, AQSite enables seamless communication between sponsors, investigators, and sites, ensuring prompt issue escalation, query resolution, and decision-making.
>Robust Documentation and Data Management: AQSite enforces standardized documentation practices and audit-ready processes, ensuring accurate, complete, and compliant trial records that uphold data integrity.
>Optimal Resource Allocation: Our experienced coordinators and monitors are strategically assigned based on site needs, ensuring efficient management of personnel, visits, and operational tasks without overburdening staff.
>Proactive Risk-Based Oversight: AQSite employs risk assessment and mitigation strategies to detect potential compliance or operational issues early, preventing escalation and maintaining trial integrity.
>Operational Efficiency and Standardization: By implementing technology-driven workflows and best practices, we minimize delays, reduce costs, and maximize productivity across all sites.
>Investigator Engagement and Training: AQSite fosters strong relationships with investigators, providing regular training, guidance, and support to ensure full protocol adherence and optimal site contribution.
>Timely Reporting and Metrics Tracking: Using centralized dashboards and real-time reporting, AQSite provides sponsors with accurate updates on site performance, patient enrollment, and protocol compliance, enabling informed decision-making.

Key Benefits of AQSite:

>Faster trial start-up and reduced delays.
>Improved patient enrollment efficiency.
>Consistent, high-quality site performance.
>Enhanced compliance and audit readiness.
>Proactive risk management across all sites.
>Transparent reporting and real-time sponsor visibility.
>Efficient operational management and cost reduction.
>Strengthened investigator collaboration and training.
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