We optimize protocol design, fulfill requirements for TQT studies, support Phase I CPUs in intense ECG studies with PK-PK analysis, and ensure accurate regulatory submissions. ClinSync has the right medical and scientific expertise, technology and process & compliance to provide highest quality of data to our Sponsor’s and CRO partners who depend on, study after study.
Our Expertise:
Highly experienced cardiologists to review, analyze and adjudicate each ECG
Expert QT reporting reviewed by cardiologists and statisticians
ECG project managers as your dedicated single point of contact
24/7 site support including investigator / site helpline (for multicentre studies)
Hands on experience of handling critical molecules for cardiac safety
12-lead modem-based digital ECG and 12-lead Holter
On-screen analysis and interval measurement in FDA-compliant XML format
Your choice of digital ECG collection technologies (Eg: Philips Muse Server) & Site Training
Web portal for real-time access to ECG data
Standard Operating Procedure in compliance to guidelines
Strict ICH E14 compliance
ACC/AMA/ESC 2006 Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. European Society of Cardiology, Eurospace 2006) 8, 746-837