Banook Group cardiac safety has successfully centralized data for over 750 trials in 75 countries since 1999, and has analyzed more than 1 000 000 ECGs.
Our experience includes: phase I–IV studies in all therapeutic areas (cardiovascular including anti arrhythmics, central nervous system, dermatology, infectious diseases, malaria, chagas, pediatric diseases, metabolic diseases, oncology, pulmonary/respiratory, rheumatolog, medical device and implanted cardiac devices.
Scientific and regulatory expertise: having conducted more than 20 TQT studies and 300+ intense ECG studies, we have a unique expertise in designing and supporting full TQT studies as well as offering guidance for regulatory submissions. At study’s end, we provide you with XML files (Mortara certified XML files) and support in uploading ECG digital files to the FDA ECG Warehouse.
Our medical and scientific experts will work with your team to plan and execute more efficient studies integrated with the overall development strategy for your therapeutic product. Pierre Maison Blanche, M.D., Pascal Voiriot, M.D., M.Sc.and Pierre Wicker, M.D. will provide support for scientific and technical issues as well as for questions raised by investigators and regulatory agencies. Our scientific team is responsible for a number of areas including review of study protocols and preparation of the documentation to ensure proper analytics/methodologies are employed.
Analysis by Board-Certified Cardiologists: to ensure a highly precise and accurate analysis of your ECG data, we will assign to your project a stable team of experienced senior cardiologists and technicians who are fully dedicated to ECG analyses. We can provide the full spectrum of reading strategies and methodologies from computer-assisted to fully automated with review/validation using single or double reading (over read) and validated QT-interval measurement methods in accordance to the ICH E14 guidelines.
Technology and real time integrated data: to support the assessment of cardiac safety and imaging endpoints the Banook Group offers a complete and integrated solution based upon a unique set of advanced technologies, The Atrium™ suite. The suite is an innovative platform specifically designed to build, operate, track and document clinical trials across all study phases from Electronic Data Capture (EDC) to final publications.
Features and benefits of the Atrium™ platform include:
Real time Management, analysis and reporting of centralized ECG data via a secure web portal,
Real time data access and online queries for the investigator: investigators and site personnel can log in anytime and review ECG reports as well as respond to queries,
Dashboard, Metrics and executive summary views enables the sponsor/CRO teams to view ECG results and project status in real time.
The Banook Group offers a full range of comprehensive and proactive cardiac safety services and technologies solutions including:
Scientific and regulatory consulting expertise,
Design and implementation for thorough QT studies, early ECG and oncology studies,
Support for your “Go-No Go” decisions in early phase,
Protocol review and consultation ,
High quality and “easy to use” cardiac equipment,
Provision of ECG, holter, ABPM equipment and supplies, logistics, training and worldwide technical support to sites,
Collection, management and processing of digital ECG and holter data,
Web upload of digital ECG and holter data from site,
12 lead digital ECG analysis and Interpretation including multiple analysis options: computer-assisted methods, manual review (threshold, tangent), SD 6 – 10 msec and T/U-wave morphology,
Thorough QT analysis (E14 guidelines),
ECG paper scan, digitization, processing, analysis and reporting,
2-,3- lead and 12-lead holter analysis and interpretation,
ECG extraction from 12-lead Holter recording and analysis,
Analysis of holter data for arrhythmia and heart rate variability,
Ambulatory blood pressure monitoring,
Project management, data management, reporting & advanced CTMS system,
Expert reporting: medical and statistical cardiac safety report, Interim cohort report, (Charters, TFLs and SAP), exposure response modelling expertise,
Late stage and full early ECG study capabilities and expertise: phase I – IV, thorough QT, ECG intensive QT trials, SAD and MAD phase I studies.