Blockchain technology is the biggest achievement in cryptography of the past decade. Source Data Verification (SDV), which consumes about 20–30% of the clinical trial budget nowadays, will become redundant when blockchain technology disrupts the pharma industry.
Last February 28th, the FDA finalized the E6 (R2) version of the addendum to the International Council for Harmonisation's (ICH) good clinical practice (GCP) guideline. What to do now? Don’t panic, we’ve put together a simple 5-step plan to help you initiate the most urgent process adaptations.
Press Release: Cyntegrity Rolls out SaaS Application to Help Pharma Organisations Bring Regulatory Guidance into Practice
Frankfurt – Cyntegrity, a German provider of proprietary Risk-based Monitoring (RBM) cloud services for the Life Sciences industry, today announced the rollout of “@RACT-Pro” – simple and affordable risk assessment and mitigation tool. There is even a free version. This online SaaS (software as [...]
We are pleased to welcome Dr Nimita Limaye, Project Lead KRI Wiki, to the Cyntegrity team! Key Risk Indicators (KRIs) play a fundamental role in managing risk, you could say they are the “traffic lights” of clinical monitoring. When appropriately selected and calibrated KRIs [...]
More than ever before, well-designed clinical trials are essential to maximize chances of success.
100% SDV...seriously, who DOES this? Start 2018 with an easier way to manage your clinical risks.
Dr. Artem Andrianov, the Cyntegrity's CEO, will be presenting on the recent publication in Applied Clinical Trials at MCC's next meeting on 11-Dec-2017 at 10am EST. Registration link below. The link to the peer-reviewed Applied Clinical Trials article: http://www.appliedclinicaltrialsonline.com/pueks-project-process-innovation-clinical-trial-monitoring Registration (for MCC members only): https://metricschampion.webex.com/metricschampion/j.php?RGID=r606bfad2af43d9dcd6c74b1eb9b80ff7 [...]
Cyntegrity employees were happy to contribute to the new peer reviewed article in Applied Clinical Trials: "The PUEKS Project: Process Innovation in Clinical Trial Monitoring" http://www.appliedclinicaltrialsonline.com/pueks-project-process-innovation-clinical-trial-monitoring
Today the ICH GCP Addendum E6 R2 comes into operation. Therefore, we summarized the useful resources for your kind perusal: GCP E6 R2 Addendum itself - http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4.pdf PDF Mindmap of all GCP E6 R2 changes - https://cyntegrity.com/ich-gcp-addendum-e6-r2-mind-map-pdf-for-download/ ICH GCP Goes Risk Based - a [...]
25.04.2016. Cyntegrity, cloud solution provider for the efficient Risk-based Monitoring (RBM), is pleased to announce its partnership with Sollers Institute (New Jersey, US). Sollers is the leader in training related to the clinical research, drug safety, and pharmacovigilance, providing the premium education according to [...]