Spurred by the shift to decentralization, the clinical trials workforce needs new roles and skill sets to master a rapidly changing environment. Read More
Using risk-based quality management (RBQM) can help sites and sponsors meet regulatory expectations while also making them more agile and better able to navigate unexpected challenges, such as the COVID-19 pandemic. Read More
Take it from the agency that conducts inspections of pharmaceutical and research and development sites: If there’s one key to avoiding administrative action, disqualification and other penalties, and legal action, it’s documentation. Read More
The future of trials depends on a focus on patient-centricity as the industry moves past rapid adoption of novel trial designs and technology that aids in decentralization during the COVID-19 pandemic, industry experts named to the PharmaVOICE 100 for 2020 forecast last week. Read More
Trials can reduce timelines, cut costs and more easily produce FDA-acceptable data with biomarkers and clinical outcomes assessments (COA) the agency has already qualified under its drug development tools (DDT) program. And with 118 new tools in the pipeline, the program is gaining momentum. Read More
Shrinking awareness of and growing distrust for clinical research could make it challenging for trials to recruit and retain study participants in the near term, according to preliminary results from an ongoing study by the Center for Information and Study on Clinical Research Participation (CISCRP). Read More
The evolution of digital technologies used in clinical trials will require a shift in the nature of the workforce, with new skills needed and new roles created. Read More
Overly compartmentalized approaches to testing new data management solutions is one of the key obstacles to widespread adoption within an organization, research by the Tufts University Center for the Study of Drug Development (CSDD) and Saama Technologies indicates. Read More
Data management and loss prevention is important to any business, but it’s particularly critical to clinical research, which relies on the ability to collect, retrieve and analyze accurate, reliable data. Read More
Quality management is a concept familiar to drug- and devicemakers because of the FDA’s regulations on the subject, but there are no parallel rules for clinical trials. That will change when the revised version of the International Council on Harmonization’s (ICH) E8(R1) guideline, General Requirements for Clinical Studies, is finalized later this year and adopted by regulators. Read More
