Involving patients more meaningfully in the industry's activities means getting more serious about their emotional wellbeing.
The right person can successfully promote proper management of quality and compliance, leading to desired clinical trial outcomes.
A look at the different testing methods and how the results impact drug development.
First-of-its-kind consortium dedicated to accelerating new medicines development through optimizing patient advocacy group—industry collaboration.
Making adaptations to clinical trials in the early stages of research with the use of interim data.
A follow-up survey on clinical quality assurance (CQA) assesses current industry best practices compared to a decade ago, and provides recommendations on this key component of quality management for the future.
How cultural and training differences affect molecular-based clinical research in China.
With all the focus on various data capture solutions in the clinical trials world over the past decade(s), few people seem to have noticed the exponential advances made in the real workhorse systems of the trials: RTSM. Also known as IVR, IWR and IRT, these systems actually execute randomization, blinded supply and resupply management to depots and sites, and most importantly of all, drug dispensing. Is there anything more important to get right?
Making adaptations to clinical trials in the early stages of research with the use of interim data.
The Declaration of Helsinki requires that control groups receive the “best” current treatment, not the “local” one. This shift in wording has profound implications.
Outsourcing finance and accounting can provide cost savings and improve operations.
Surveys among pharma, clinics, and investigators shed light on trials in children.
Adoption of the concept of Risk-Based Budgeting could help maintain the trial budget or even save the whole clinical trial.
Use cases show benefits of unlocking data to improve signal and adverse event detection.
There is an expanding array of potential antibody-based treatment options, such as bispecific or multispecific antibodies, that show promise in addressing conditions such as cancer, engineered antibody fragments, or even antibody-drug conjugates.
Statistical methods used via this technique in centralized monitoring.
Implementing new strategies with the use of patient-reported outcomes.
Virtual audits proving to be beneficial post-COVID despite continuing challenges.
Evolving technologies include modification of receptors on T cells to better target tumor microenvironments and minimize off-tumor cross-reactivity.
An increasing number of patients report looking for more simplicity and less burden related to a clinical trial, and a "bring your own device" option is one of the ways to meet this need
Advancing risk-based auditing one step further by identifying the underlying process deficiencies to enable improved corrective and preventive actions.
Study evaluates the use of AI-supported medical coding module.
While many groups rely on manual chemistry processes, innovative platforms have emerged that allow these protocols to be executed on custom automation systems.
In an interview with Applied Clinical Trials Associate Editor Don Tracy, Sonia Lwoff, director, clinical operations, Rho, discusses the potential for artificial intelligence in clinical trial decision-making and enrollment.
Evolving technologies include modification of receptors on T cells to better target tumor microenvironments and minimize off-tumor cross-reactivity.
Successful collaborations between Pharma/Biotech/Device industries and CROs will play a key role in an effective fight against the global COVID-19 pandemic.
Tuesday, June 22, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST