What is the future of patient safety in clinical trials? The life sciences industry is experiencing an evolution. Technology is forcing digital transformation and is rapidly changing the way that companies conduct research, test treatments, and evaluate data. To continue this progress, industry experts [...]
This opinion piece by Keith Dorricott, MBB, addresses the challenges faced by the clinical trial industry in implementing QTLs and KRIs as required by ICH E6(R2). The article explores why KRIs have been easier to adopt than QTLs and wonders if the specific guidance provided by ICH E6(R2) is partly responsible.
In clinical trials, managing risks that could impact data quality is crucial for ensuring patient safety, data integrity, and regulatory compliance. While Risk-Based Quality Management (RBQM) and Quality Risk Management (QRM) are both approaches designed to manage risks, the two have essential differences.
Exciting news on ICH GCP E6(R3) is here! Our CEO, Artem Andrianov, returned from the SCOPE Summit with updates on the updated guideline. ICH E6(R3) will incorporate technology advancements while prioritizing participant protection and reliable evidence. Don't miss Artem's thoughts on his experience at the summit. Stay tuned for more updates on ICH E6(R3)!
We are proud to announce that our Drug Interaction Visualizer has been selected as a finalist for the SCOPE Best of Show Awards. Based on real-world data from the FDA, our visualizer enables clinical research professionals to explore drug interactions and identify potential risks.
Learn about the high failure rate of clinical trials & how the premortem approach can improve success by identifying potential problems early. Discover how this technique can foster a culture of collaboration & learning within the team, reducing the need for a painful postmortem.
At Cyntegrity, we're on a mission to deliver the highest possible data quality in clinical trials. That's why we're thrilled to have been recognized by Microsoft as a valuable use case. Don't miss out on reading how we're making a difference in the biopharma industry by checking out our customer story on Microsoft's website.
On the wings of the Butterfly Challenge, our CEO Artem Andrianov and Junior Data Scientist Ting-Yu Ho shared their scientific knowledge with 10th graders helping them acquire real-world vision.
Is Oncology Clinical Trials your domain? Then get your free coupon for the RBQM Essentials White Belt eCourse no later than 1 November and save $190.
The so-called "cucumber regulation" may mean nothing to you. However, it guarantees comparable products to retailers, consumers, and processors across Europe, a standard. Standardization drives quality over time and develops global trust. Do we have standards in clinical research? Yes, but not enough, and they may not always be adhered to.
