Anapharm, a PharmaNet subsidiary offers facilities and services for conducting Phase I studies across a broad spectrum of therapeutic areas. Anapharm has been conducting Phase I studies and associated laboratory analyses for more than a decade, and has established strong relationships with international regulatory agencies such as FDA, EMEA, HPFB, ANVISA, TGA, etc.

 

 

Clinics

Anapharm offers clinics in Toronto, Montreal, and Quebec City. Together, our 3 modern, well-designed clinics offer a capacity of 510+ beds divided into 12 clinical units, with semi-private rooms available and a maximum of 8 study volunteers per room. Our clinics offer a complete set of Phase I services from our 40+ experienced physicians and 400+ support staff. Staffing for every sponsor program includes a dedicated project manager, rigorous Quality Control and Quality Assurance to ensure data integrity, a dedicated medical director to ensure subject safety, along with a qualified team of medical specialists.

 

Click here for a complete listing of our Phase I services.

 

Bioanalytical Laboratories

Bioanalytical services in support of Phase I studies are offered through PharmaNet Subsidiaries: Anapharm, Anapharm Europe, Keystone Analytical, and Taylor Technology. Together, they offer 5 GLP-compliant bioanalytical laboratories in the US, Canada, and Europe, totalling approximately 70,000 square feet of laboratory space. State-of-the-art instrumentation includes 60+ LC/MS/MS API 5000, 4000, 3000 and 365 as well as Finnigan’s GC/MS/MS. Staffing includes more than 300 thoroughly trained professionals. Services available through these companies include: method development, validation, sample analysis, and process optimization. We currently offer more than 1,000 validated assays.

 

Click here to learn more about our bioanalytical laboratories.

 

Click here to see our list of validated assays.

The Canadian Regulatory Environment

Our Regulatory Affairs professionals can assist you in every aspect of Phase I testing, including the submission of a Clinical Trial Application (CTA) to the Canadian regulatory authority, Health Canada. We file more than 200 CTAs every year, and have established strong working relationships with Health Canada. In our experience:

 

	CTAs for straightforward studies involving healthy volunteers should ideally be submitted about 3 to 4 weeks prior to dosing. Health Canada usually reviews these types of applications within 7 days.
	CTAs for studies involving new chemical entities, such as first-in-human studies, should be submitted about 5 to 6 weeks prior to initial dosing. For these applications, Health Canada’s review period will vary according to the complexity of the drug, but will normally be 15–30 days.