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.
Today we are proud to announce another milestone for our organization. Being SOC 2 Type 1 compliant means, we have successfully maintained effective controls over our online cloud platforms' security, availability, and confidentiality. In other words, you can rest easy knowing your data is safe with us.
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.
RBQM done correctly can significantly reduce findings. Jo Burmester provides practical hints and tips to prepare your organization for an audit or inspection.
Today we are proud to announce another milestone for our organization. Being ISO certified means that our QMS drives the three key principles of ISO 9001.
The final version of the ICH E8(R1) guidance discourages the old-school "one size fits all" approach. Instead, risk-based quality management concepts such as QbD and CtQ factors predominate these modern-day considerations which encourage the biopharma industry to go beyond the traditional checklists. We've visualized the final 2021 guidance, "General Considerations for Clinical Studies," for you.
The COVID-19 pandemic has accelerated alternative distribution strategy adoption to facilitate “new normal” decentralized and hybrid trial concepts. Capturing the IMP supply chain risks associated with these more flexible distribution approaches requires synergy among people, processes, and technology. Former Senior Project Manager at GKM, Anke Mueller, shares with you how pandemic-induced supply chain risk data knitted together in a single RAC tool enabled her study team to pivot quickly and continue their studies in a timely fashion.