Blockchain in Clinical Trials – The Ultimate Data Notary
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.
A Simple 5-step Plan to Improve Quality and Efficiency in Clinical Trials
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 [...]
Dr Nimita Limaye: “KRI Wiki is a Path Breaking Initiative”
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 [...]
Newsletter: Fast-advancing science has opened the era of personalized medicine
More than ever before, well-designed clinical trials are essential to maximize chances of success.
Newsletter: Start 2018 with an easier way to manage your clinical risks
100% SDV...seriously, who DOES this? Start 2018 with an easier way to manage your clinical risks.
Cyntegrity’s CEO Presents at MCC: Process Innovation in Clinical Trial Monitoring
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 [...]
Article at ACT: “Process Innovation in Clinical Trial Monitoring”
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
ICH GCP Addendum E6 R2 comes into operation!
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 [...]
Press Release: Cyntegrity partners with Sollers Institute
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, [...]
ICH Finalized GCP Addendum E6 Revision 2
The ICH GCP Addendum E6 R(2) is final now! Global good clinical practice (GCP) guideline amendment adopted The 1996 ICH guideline on GCP is one of the most significant achievements of the ICH process, [...]
WHO Guideline on Good Data and Record Management Practices is Final
The WHO guideline on Good Data and Record Management practices is now final, below you find the link. Particularly interesting is that this guideline talks about quality risk management: Quality risk management and sound scientific [...]
