Anapharm, a PharmaNet subsidiary, is a leading provider of high quality, thorough QT/QTc studies. QT/QTc studies are conducted at our Montréal facility, which comprises 150 beds in four clinical units. To expedite studies, these units can be combined to accommodate large cohorts. Our facility has been successfully audited by international regulatory agencies.

 

Our facility provides:

	In-house expertise in pharmacodynamics, pharmacokinetics, single-dose and dose-escalation studies, tolerability, and safety
Comprehensive range of services in scientific and regulatory affairs
Experienced medical staff
Network of cardiology-specialist nurses
In-house clinical laboratory
Extensive bioanalytical capabilities through our network of five laboratories
Partnerships with industry-known, ECG core laboratories
Ability to monitor 49 subjects simultaneously on our telemetry system
ECG Holter recording equipment
Electronic data capture system

 

Our experience includes:

Bioavailability studies of digoxin 0.5 mg, involving 56 subjects
Drug-drug interaction study with β-blockers
	Clinical study to verify tolerability of IV amiodarone given as a bolus and as an infusion, with 30 healthy volunteers: telemetry 24h
	Phase I clinical study of a compound requiring intensive cardiac-safety monitoring: telemetry 48h, 12-lead Holter 60h (44 subjects to date in an ongoing project)
Thorough QTc study with 12-lead Holter monitoring
Phase I clinical studies involving serial outputs in triplicate from a digital ECG
	Numerous pharmacokinetic studies involving cardiac drugs, such as β-blockers, calcium-channel blocking agents, and anti-arrhythmics including digoxin and amiodarone