Market trends are driving the need for biopharma to decrease fixed costs, leading to increased outsourcing to CROs. To meet greater demand, the role and profile of Project Managers needs to continuously adapt to an ever changing clinical trial environment.
A new clinical trial regulation in Europe aims to bring about harmonization of European Union (EU) clinical trial multi-country applications. This paper poses a consensual review, fine-tuning, and validation of study classification while further clarifications on this law are sought out.
The Pediatric Working Group of EUCROF launched an initiative to achieve standardization of generic Informed Consent Form and Assent Form templates within European countries. The differences are noted based on a prior survey.
According to the FDA, the most common compliance deficiencies during inspections include inadequate investigator oversight, protocol deviations, poor record keeping, insufficient investigational product accountability, and issues with subject protection and consenting. Any deviations during an inspection can lead to a Form 483, leading to a lengthy process to address the problem.
These articles can help you prevent receiving a 483 by creating best practices.
This analysis uses a large dataset to forecast the study completion time costs of specific protocol designs and execution plans.
This Best Practice in Study Feasibility report covers techniques and innovations offered by sponsors and CROs for conducting analyses.
The globalization of clinical trials is the subject of this analysis to find if there is an increase in non-traditional sites.
The European Medicines Agency has started to deliver on its promise of open access to clinical reports for new medicines authorized in the European Union. Peter O’Donnell reports on his experience accessing this database.
The FDA approved Sarepta’s Exondys for Duchenne muscular dystrophy despite little evidence of efficacy, leading many to regard the decision as not being a model for future drug development. The challenge now is to see if confirmatory trials show more benefit, or lack of efficacy.
Hospitals and health systems are making significant changes to their research operations in conjunction with the increasing complexities of clinical research. Adopting a centralized clinical trials office (CTO) can greatly assist in managing these changes.
The deadline looms for new FDA requirements that all applications for new drugs and biologics compile and submit clinical trial data electronically. Meanwhile, efforts by the Clinical Data Interchange Standards Consortium (CDISC) to develop consensus-based standards for collecting data are not going unnoticed.
As biopharma companies continue to explore and experience ways in which risk-based monitoring is implemented, the process of such can be misconstrued. Peter Schiemann elaborates on some of the current issues of RBM interpretation and implementation.
What used to be segregated approaches in clinical trials—ePRO, telemedicine, mobile health, devices and wearables—now gather under the umbrella of technologies that touch the patient. And those technologies can have positive implications for costs efficiencies in clinical trials, streamlined data collection, as well as on patient compliance and retention.
Oncology remains the therapeutic area with the most drug failures, the lowest numbers of patients enrolled and the highest with the number of drugs in clinical trials. Many trends in oncology clinical trials seek to address these challenges and include the use of biomarkers, immunotherapies, and adaptive designs.
This special report offers an article regarding current FDA thinking and future direction with these assessments. ERT--a cloud platform solutions provider that captures quality efficacy and safety endpoints in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, and Clinical Outcome Assessments—offers expert view on this regulatory change.