Examining the two areas of weakness cited in FDA draft guidance.
First-of-its-kind consortium dedicated to accelerating new medicines development through optimizing patient advocacy group—industry collaboration.
How Clinical Research Malaysia sped up CTA turnaround using a web-based system.
Differing levels of trust in clinical trials information channels across diverse populations is examined in this research.
The need for specific capabilities to suit DCT business models is creating new challenges in team building, training, and development.
Promising scientific advances are pacing oncology drug development.
How asking better questions and leveraging site databases can expand access to more patients.
In this playbook, learn how a virtual site solution expands access to infectious disease clinical trials by allowing patients to enroll and participate from anywhere.
A discussion of the impact of a strategic alliance in to facilitate operational success at the clinical trial site level in Malaysia.
Evidence from a Phase III cancer trial points to notable advances in data-transfer tech.
Industry must act now to minimize effects of COVID-19 on clinical research.
The potential of next-generation platforms in transforming patient recruitment.
Addressing misconceptions as industry becomes more familiar with AI and ML.
The revision of Annex 1 clearly calls out the use of quality risk management to identify potential risks to quality and the implementation of a contamination control strategy.
The latest FDA and EMA guidelines permit sites, sponsors, and CROs to adjust their operations to meet changing conditions for ongoing trials, including some concerning the safety of participants, that must be met in order for new solutions to be considered.
Bayesian methods bring flexibility and speed to clinical trial design and analysis, and with increased access to the necessary computational power, are transforming today’s clinical research.
Compliance with state telemedicine requirements is imperative, as not only will most clinical trial sponsors contractually require such compliance, but non-compliance may also subject the practitioner to licensure violations and liability.
Advances in technology open door for improved EHR to EDC transfer process.
Many companies during this time of social distancing have paused trial recruitment completely to focus on currently recruited patients, while others rethink their strategy to better accommodate the new digital-only reality.
Companies must be able to defend the fidelity and confidentiality of all records and data generated throughout a product’s entire lifecycle, starting with the earliest points in research.
January 2023 guidance from FDA on dosages in oncology provides further context on expectations with Project Optimus.
This model, built around a mix of flexible, empathetic, and results-driven principles, may be uniquely positioned to navigate the changing dynamics and demands for contract development and manufacturing organizations.
Recent case study highlights the importance of applying statistical rigor throughout the development and validation processes of biomarkers.
New proposals aim to create higher standards for trial regulation.
Approaches sponsors, CROs, and investigators can take from the DMD experience.
Identifying and providing clarity on the GCP quality and risk concerns associated with DCT modalities.
Regulatory compliance, collaboration, and effective use of technology among ways CROs can overcome challenges.