June 22nd 2023
Study Health Check provides early identification of issues related to protocol deviations and determines objective measures of site-specific versus study-wide performance.
Accelerating Clinical Trial Design and Operations
Fully-integrated, component-based CDMS offers flexibility, customization, and efficiency.
Rare Patient Advocacy Groups Reach Tipping Point of Influence
February 10th 2020Using venture philanthropy to get promising drug candidates past “the valley of death”-and supported by advanced scientific technology-rare disease patient organizations have moved beyond being just hopeful influencers, to now becoming powerful forces for change.
DIY Blood Sampling for Pediatric Clinical Trials—The Patients Perspective
September 30th 2019A recent survey shows that 40% of pediatric trials conducted between 2008 and 2011 were never finished or published. One of the main challenges is the need to collect multiple sequential blood samples. Which, mircosampling, could be the answer to.
Mitigating Risk in Implementing Multi-Regional Trials in Multiple Sclerosis
Examining the main challenges in designing and executing MS clinical trials and proposing mitigation strategies that may help alleviate these burdens.
Specialized Safety and Regulatory Needs for Small and Medium Biopharma Companies
December 21st 2017Outsourcing safety responsibilities to functional service providers (FSPs) during clinical trials and post-approval can help small-to-medium-sized enterprises balance their workload and maintain best-practice operations.
Anonymization and Redaction of Clinical Trials According to the EU Regulation
December 18th 2017Outlining the techniques for anonymization of clinical study reports and the identification and redaction of commercially confidential information to comply with EMA's Policy 0070 on trial data disclosure and transparency.
Barriers and Solutions to Smart Clinical Program Designs
How the Clinical Development Design (CDD) Framework can offer repeatable, reusable clinical designs based on "enabling information."
The PUEKS Project: Process Innovation in Clinical Trial Monitoring
A look at the results of the recently completed project, which aimed to develop an holistic monitoring system via process integration to more effectively control clinical trial risks beyond isolated RBM strategies.
Point of View: Traceability and Transparency Should be Mandatory for All Human Biospecimens
May 8th 2017Transparency regarding the source of biospecimens would improve research quality, reproducibility, and translational use of acquired knowledge. Scientific robust publications, dissemination and communication are central to this-as are the regulatory reporting guidelines in play.
An Analysis of Anonymization Practices in Initial Data Releases Pursuant to EMA Policy 0070
April 13th 2017Examining early learnings from approaches used to comply with EMA’s requirement to publish anonymized versions of clinical study reports and other submission documents, including how privacy protection was balanced against data utility.