While there's been hopeful news on treatments and vaccines, sponsors should plan to discuss necessary strategies and contingencies at the outset of new studies or re-opening of halted studies during the COVID-19 pandemic.
With the assistance of mobile research nursing, in-home visits provide solid alternative to trial participants, especially during COVID-19.
A more crowded space is presenting new challenges for stakeholders that must be addressed to improve efficiency.
Tufts CSDD study in collaboration with ten biopharmaceutical organizations and CROs examines sponsor/CRO relationships.
Poor representation of dark skin tones in textbooks emphasizes need for change.
While eConsent has become more widely adopted since COVID-19, work still needs to be done in improving patients’ understanding.
Key challenges and strategies to consider when developing devices intended for home-use or deployment in a clinical research setting.
The six steps to designing a successful diversity action plan for a clinical trial protocol.
Sponsors can simplify diaries by taking a closer look at the three common sources of complexity.
Top predictions for the major trends that will shape clinical trial design in 2022.
Addressing sources of tension on differentiating types of data.
Operational and patient burden considerations for self-collection of blood specimens in clinical trials
A roadmap to avoiding the common pitfalls of concurrent FDA-EMA filings.
Evidence from a Phase III cancer trial points to notable advances in data-transfer tech.
Multilayered strategies such as working with patient advocacy organizations and leveraging technology can help industry better partner with patients.
Statistical methods used via this technique in centralized monitoring.
Examining how to optimizing the time and effort of Ethics Committees to efficiently and effectively fulfill their human subjects protection remit.
Three key considerations for deploying technology to help increase diversity in trials.
Tufts Center for the Study of Drug Development and Biogen recently conducted a study to inform growing interest in improving diversity of clinical trial participation. The results of this research provide insights into increasing the community of minority investigators and study staff and presenting greater access to clinical trials among minority study volunteers.
Fully-integrated, component-based CDMS offers flexibility, customization, and efficiency.
Optimizing feasibility through increased data collection.
New investigators practicing in community-based settings bring enthusiasm and a fresh approach to clinical research, while also boosting collaboration and merging personal connection and patient-centric insights.
Data from past clinical trials has provided researchers with a good starting point to create more ECAs.
DCTs proving to solve numerous pain points for patients in clinical research.
Three key considerations for deploying technology to help increase diversity in trials.
Why constant communication and transparency are paramount to successful partnerships between pharmaceutical companies and CROs
The use of virtual trials will surge in the future and could become the de facto standard for clinical studies, says a recent Pistoia Alliance poll.
Companies that understand the regulatory environment in Europe can keep their trials on budget and on schedule.