Astrum

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Phase II–III Studies

Phase II–IV Studies

Proving Consistency and Confidence

Astrum provides end-to-end clinical trial delivery, integrating scientific expertise, operational excellence, and global reach. Our approach goes beyond study delivery. We design and manage trials that are scientifically robust, operationally efficient, and aligned with both regulatory expectations and sponsor objectives. Every milestone is structured to advance approval, partnership, and patient access.

Study Design & Start Up

Optimized design and rapid activation for faster first patient in.

Study Design & Start-Up

Building strong foundations through intelligent design, rapid activation, and seamless coordination.

  • Study Design – Optimized, data-driven protocols ensuring scientific rigor and regulatory readiness.
  • Study Start-Up – Fast, efficient activation powered by technology-enabled workflows.

Medical Affairs

Medical expertise guiding protocols, safety oversight, and clear clinical communication.

Medical Affairs

Bridging science and operations through medical expertise and clinical insight.

  • Medical Expertise – Scientific guidance supporting study design, safety oversight, and data interpretation.
  • Medical Communication – Translating complex data into clear, credible clinical narratives.

Trial Operations & Oversight

Experienced teams delivering quality, compliance, and proactive risk management.

Trial Operations & Oversight

Delivering quality and efficiency through experienced teams and proactive risk management.

  • Clinical Monitoring & Site Management – End-to-end oversight ensuring trial quality and compliance.
  • Central Monitoring – Risk-based oversight enabling early detection and faster issue resolution.
  • Project & Risk Management – Proactive planning and control to keep studies on time and within scope.

Data & Analytics

Accurate CDISC compliant data flow and analysis that stand up to scrutiny.

Data & Analytics

Transforming trial data into insights that strengthen regulatory and investor confidence.

  • Biostatistics & Data Management – Accurate, CDISC-compliant data flow and analysis.
  • Quality & Compliance – Ensuring audit readiness, consistency, and full regulatory alignment.
  • Global Records & TMF Management – Expert-led oversight ensuring inspection-ready documentation.

Safety & Reporting

Integrated safety surveillance and timely, transparent regulatory reporting.

Safety & Reporting

Protecting patients and programs through vigilant monitoring and transparent reporting.

  • Safety & Pharmacovigilance – Integrated safety surveillance and compliant reporting.
  • Medical Writing – Clear, concise medical and regulatory documentation from protocols to CSRs.

Digital & Virtual Solutions

Scalable hybrid and decentralized tools that improve access and efficiency.

Digital & Virtual Solutions

Harnessing technology to make trials more accessible, efficient, and patient-centric.

  • Virtual Clinical Trial Services – Scalable digital platforms enabling hybrid and decentralized study delivery.