Stakeholders must alter their mindsets when it comes to early-phase design and interpreting regulatory guidance for CGT trials.
Use cases spotlight the growing potential of generative AI in the CRO space.
The challenges, opportunities, and strategic outlook for oncology research centers.
Operational and patient burden considerations for self-collection of blood specimens in clinical trials
Thousands of trials have been halted as a consequence of the coronavirus pandemic, slowing the pace of scientific progress dramatically.
Using IROs can offer the opportunity for doctors to incorporate clinical research as a care option in their practices.
How service providers are helping to accelerate drug development.
Laboratory services organization focuses on easing patient and site burden with improved collection device.
The pandemic spurred an urgency to innovate that improved clinical development in ways that should benefit the industry beyond COVID-19.
All stakeholders must play part in increasing implementation.
As biotech innovation accelerates, the clinical research workforce is rapidly eroding—threatening the future of drug development. From workforce burnout to training program cuts and talent pipeline collapse, clinical trial professionals must confront this escalating crisis head-on to sustain progress and protect public health.
By taking on tasks such as clinical trial management, logistics, statistics, and data management, contract research organizations have helped expand the capabilities of their sponsor partners and accelerate drug development timelines.
Determining if an EAC is at risk and key actions to mitigate trial impact.
Promising scientific advances are pacing oncology drug development.
While randomization is required by regulatory bodies, it is up to the sponsor on how to conduct it.
How pharma companies can reduce the risk of failure with AI-based innovations.
Guidance will compel sponsors to consider new enrollment strategies and to be more diverse.
Through grassroots patient education, local pharmacies serve as a pivotal doorway to improving access to trials.
January 2023 guidance from FDA on dosages in oncology provides further context on expectations with Project Optimus.
Understanding the role of social determinants on clinical trial participation and trust.
While Case Report Forms are a main contributor to collected data, non-CRF data such as core laboratory data and central imaging can be critical to any clinical study.
The data, not the plan, provide the direction.
The success of the decentralized model hinges on coordination between stakeholders across the supply chain to ensure that date is secure, medication is delivered on time, and in proper condition.
A more user-centered design can allow increased flexibility in the development of eCOA platforms, driving better engagement and participation.
Moving beyond the pill to extend the value being delivered to patients.