Cyntegrity Germany GmbH
Cyntegrity (origin: Clinical + Integrity), a data-quality bureau, which offers a specialized service with proprietary systems for an efficient risk-based monitoring (RBM) in a clinical trial.
Our mission – to ensure efficient centralized, triggered, targeted monitoring of clinical trials through data knowledge & risk management technologies.
Cyntegrity develops a simple and effective platform for RBM to control clinical risks, study performance and data quality; it protects the health of your datasets, so that you can concentrate on the health of patients.
RBM Platform EarlyBird has the following features:
1. Covers all areas of a clinical trial (EDC, CTMS, Pharmacovigilance, etc.)
2. Do analysis constantly (like virus-scanner)
3. Data based i.e. objective
4. Analyses risks, data quality and performance of a trial
5. Includes the risk mitigation platform (ticketing system)
6. Scalable and can be used with all mobile devices
7. Has escalation levels for notifications
8. Involves clinical sites into RBM
Main differentiators:
1. Holistic approach – all clinical recording systems are combined with continuous risk identification.
2. Integrated knowledge from former trials with contextual, real-world data to reduce patient-risk and to optimize preventive care.
3. Easy Plug and Play – EarlyBird Supports many of clinical data standards: CDISC ODM, CSV, FDA XML
4. Guaranteed early risk identification by data-driven detection
5. A centralized location where all risk data are saved, managed, monitored, and reported.
6. Constant Data Quality Control – data normality, distributions, outliers and inliers analysis.
7. Control Risk Dynamics – follow the risk development in time with EarlyBird dynamic chars.
8. Geographic Risk Spread Localization – plan next trainings using the geographic localization of the risky centers.
9. Extend customers capabilities – add customers own risk factors to control specific parameters.
10. Full control over customers trial – the EarlyBird data quality module provides tools that control the operational activity of customers trial.
11. Comply with fast-evolving regulatory environment – add an efficient Risk Based Monitoring process following to FDA and EMA guidance.
12. Ad-hoc clinical data reports – EarlyBird offers to a customer a number of easy-to understand reports and MS Excel exports Dashboard reports.
Most recent features (May 2016):
1. Full integration with TransCelerate guidelines (@RACT , RACT plus)
2. Future predictions for all metrics based on mathematical models, which work with even small amount of data.
3. Much stronger expert system, which can offer risk mitigation tasks.
4. Different levels of metrics (e.g., program, country, site, patient).
By definition Cyntegrity offers a unique combination of independency (absence of conflict of interests) and scientific approach; it focuses on data evaluation and presentation for the non-statisticians.
+49 (0) 6192 470 113 50
