Recent analysis showed 81% of clinical trial sites using RBQM statistical data monitoring experienced an improvement in quality.
With poor retention of women in the biomedical workforce amid the pandemic, industry leaders in clinical research must step up to provide solutions.
Following the implement of new Drug Registration Regulation in July 2020, the clinical trial registration system will have some major changes in China.
Aggressive focus by DOJ has put increased burden on stakeholders to understand their obligations and exposure.
COVID has accelerated to the scene upstart digital efforts to transform patient engagement and data management/integration—but progress remains measured.
While Case Report Forms are a main contributor to collected data, non-CRF data such as core laboratory data and central imaging can be critical to any clinical study.
Examining the behaviors of clinical trial stakeholders to better understand challenges in patient participation.
To meet the growing demands of clinical research, sponsors must prioritize comprehensive support models, such as clinical site ambassadors and patient journey coordinators, who can address operational challenges and improve site relationships, patient satisfaction, and overall trial efficiency.
Operational and patient burden considerations for self-collection of blood specimens in clinical trials
Successful oncolytic virus immunotherapy clinical development requires unique features that focus on viral biology and host immune response.
Pilot study seeks to validate new and more granular outsourcing model classifications in differentiating performance across custom contract-service approaches.
The era of big pharma as product-first companies must end, as services become the larger priority.
Findings from an OCT Clinical survey of researchers from 61 sites in Russia to gain the perspective of an investigator regarding clinical trials during the COVID-19 pandemic.
Successful collaborations between Pharma/Biotech/Device industries and CROs will play a key role in an effective fight against the global COVID-19 pandemic.
The cost and benefits for patients and sponsors in using ePRO versus paper
What is next for DCTs after acceleration from COVID-19?
A discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.
Expanding clinical trial access to include historically underrepresented ethnic and racial minorities means addressing root-cause barriers, including taxation.
Decentralized clinical trials have the potential to expand the number of people who can benefit from clinical trials while accelerating therapies to more patients in need.
Recent research from the Tufts CSDD gauged progress in the context of the “Chief Diversity Officer” role at top pharmaceutical companies.
In an interview with ACT senior editor Andy Studna at SCOPE Summit, Patil, vice president, digital innovation, IQVIA, discusses how artificial intelligence/machine learning can help in areas such as feasibility, site selection, and patient recruitment.
Tony Clapsis, SVP and General Manager, CVS Clinical Trial Services, reflects on industry’s progress.
2020 Tufts CSDD – IBM Watson Health benchmarking study highlights need for new functionality from EDC solutions and providers.
Check out our top five most engaged social media posts from the year 2024.
Approaches sponsors, CROs, and investigators can take from the DMD experience.
COVID-19 forces life sciences industry to make long overdue changes.
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.
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.
The key approaches today in unlocking the door to study inclusivity. Hint: they all prioritize participants.