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Data readiness for adaptive trial interim analysis is an operational problem solved months before the window arrives. Here's what must be true before your DSMB can decide.

Drug supply management in an umbrella trial requires RTSM configuration that explicitly models arm expansion and arm closure scenarios — not supply planning for the initial design with manual adjustments [...]

Running a basket trial operationally requires infrastructure that treats each tumor type cohort as a distinct operational unit within a shared governance framework: cohort-specific site selection (not study-level), a central [...]

A well-governed basket or umbrella trial requires four explicitly designed governance bodies: a Steering Committee with defined decision authority over major protocol changes, an IDMC chartered specifically for adaptive review [...]

Learn what an Informed Consent Form is, why it protects research participants, and how AI, and global regulations are reshaping the future of consent.

Explore the history of human subjects research, from unethical experimentation to modern protections like IRBs, the Belmont Report, and global research ethics.

The future of clinical trials is a unified, interoperable ecosystem. Sitero’s Mentor platform is leading this transformation, ensuring that clinical trials are more efficient, compliant, and streamlined than ever before. Learn more in our latest blog:

Today’s trials require data entry from anyone, anywhere including patients, sites, home nurses, and remote investigators. Learn why EDC systems must evolve to support decentralized trails in our latest blog:

Learn how a fully configurable EDC with integrated ePRO and seamless workflows can eliminate inefficiencies and accelerate clinical trials in our latest blog:

Explore the benefits of outsourcing local pharmacovigilance (PV) and key strategies for ensuring compliance while optimizing costs and efficiency in our latest blog:

Clinical research starts with the site. But growing trial complexity and administrative burdens put significant strain on site teams. How can the industry better support them? Learn more in our latest blog:

Stay informed on the latest US policy for Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP), effective May 6th, 2025 in our blog: