Our Services
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Clinical Operations and Project Management
We manage every aspect of clinical operations, from site selection and initiation to monitoring and closeout. Our experienced project managers work closely with sponsors to keep trials on schedule and within budget while ensuring strict regulatory compliance. With our proactive approach, we anticipate and solve issues in real time, minimizing delays and keeping trials on track.
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Regulatory Affairs
Navigating the complex regulatory landscape is vital for any clinical trial's success. Divergent S.P.E.E.D.’s dedicated regulatory team handles submissions and regulatory agency interactions, including with the FDA and EMA. We ensure compliance with international guidelines, efficiently managing submissions to reduce risks of setbacks and delays.
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Data Management and Biostatistics
We utilize cutting-edge electronic data capture (EDC) systems to ensure real-time, secure data collection and monitoring. Our biostatistics team applies advanced statistical methodologies to provide reliable, actionable insights that help sponsors make informed decisions throughout the trial lifecycle.
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Quality Assurance and Compliance
At Divergent S.P.E.E.D., we prioritize quality and regulatory compliance. Our robust quality management systems and regular audits ensure that our trials meet Good Clinical Practice (GCP) standards and all regulatory requirements, safeguarding both patient safety and data integrity.
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Patient Recruitment and Retention
We develop targeted recruitment strategies to attract suitable participants and ensure their continued engagement throughout the trial. Our patient-centric approach, combined with the use of digital platforms, allows us to address recruitment bottlenecks and accelerate enrollment timelines.