Number of Employees Worldwide: Approximately 1000

Anapharm is an industry leader in early-phase drug development, providing a wide range of services to the pharmaceutical, biotechnology, and generic-drug industries. Anapharm offers a vast array of bioanalytical laboratory services, as well as services in Phase I clinical development, bioequivalence, and regulatory affairs.

As a PharmaNet Development Group company, Anapharm has access to a global network of resources for Phase I–IV consulting and clinical drug development.

With Phase I facilities in Québec, Montréal and Toronto, Anapharm is uniquely positioned to assist pharmaceutical and biopharmaceutical companies with their early-phase drug development outsourcing needs. The company has been involved in conducting Phase I studies for over a decade and currently offer more than 500 beds.

Our clinics are supported by 5 GLP-compliant bioanalytical laboratories who are leaders in bioanalytical mass spectrometry.

Canadian Regulatory Environment
Canada benefits from a competitive Clinical Trial Application (CTA) process. All applications are subject to a maximum default review period of 30 days, with a targeted review time of 7 days for Phase 1 studies in healthy volunteers.

Anapharm submits approximately 200 clinical trial applications each year and has built a strong relationship with the agency. In our experience, revision of a bioequivalence/bioavailability application takes 5 to 7 days, and authorisation for other phase 1 studies is usually received within 2 weeks. Our scientific and regulatory affairs division offers to manage this simple process on behalf of sponsors.

Anapharm provides a wide range of early-phase drug development services to the pharmaceutical, biopharmaceutical and generic industries. These include Phase I, bioequivalence, clinical pharmacology, regulatory and a vast array of bioanalytical services.

Experience

• First time in human
• Pharmacokinetics
• Pharmacodynamics
• Bioavailability
• Bioequivalence
• Drug interaction
• Genotyping
• Food effect
• Safety and tolerability
• Age/gender
• Single and multiple dose escalation with on-line PK analysis
• Special populations
• Skin irritation and sensitization
• Dermal PK
• New dose forms
• Medical devices
• Vaccines

Therapeutic Areas

• Cardiovascular
• Central Nervous System
• Dermatology
• Women’s health
• Endocrinology
• Pain management
• Pulmonary
• Gastroenterology
• Infectious diseases

Route of Administration

• Oral
• Injectable (IV,IM,SC)
• Rectal
• Inhalation

Special Populations

• Normal healthy subjects
• Healthy elderly subjects
• Diabetes patients, Types I & II
• Hypertensive patients
• Cardiovascular disease patients
• Asthmatic patients
• Patients with peptic ulcer (PUD) and gastroesophageal reflux (GERD) disease
• Obese subjects
• Postmenauposal women
• Healthy premenopausal women with and without oral contraceptives
• Surgically sterile females
• Extensive/poor metabolizers
• Hypogonadal males

Clinical Pharmacology Services
Anapharm’s clinical pharmacology group has more than 40 employees dedicated to providing clinical pharmacology services in support of Phase I clinical trials. Our team provides a complete array of services, from conducting first time-in-human studies to taking your project to the next phase. Our services include:

• Protocol design and development
• Sample estimation and randomization
• Scientific consultation
• Case Report Form (CRF) design
• Database development and harmonization
• Regulatory compliant data management system
• Data entry and review
• MedDRA and WHO drug coding
• Model dependent and independent PK analysis (using SAS and WinNonlin)
• Population pharmacokinetics
• Pharmacodynamics and biomarkers
• PK/PD modeling
• In vitro/in vivo correlation (IVIVC)
• QA/QC
• Statistical analysis plans
• SAS programming and statistical analysis
• QTc study design
• Generation of tables, listings and figures for clinical study reports
• Medical writing (protocols, reports, manuscripts, and submission documents)

Project Management
The quality of the relationships we develop and maintain with our sponsors are an essential part of our philosophy. To ensure optimum communication, we always assign a project manager to our clinical trials.

Our project managers are experts who work in close cooperation with the scientific team to keep you informed of your projects’ progress. As your representative, they are wholly attuned to your needs. They efficiently and diligently manage all critical aspects of projects to ensure on-time delivery of results.

Support Services

• Pharmaceutical development services
• Regulatory services
  • 505(b)(2) submission
  • ANDA submission
• Data management
• Data entry & report writing
• PK/PD services
• Biostatistics
• Bioanalytical services
• CRF design
• Protocol development

Clinical Facility Features

• A dedicated clinical unit for each study
• 150 beds in 4 independent units (Montréal)
• 200 beds in 4 independent units (Québec)
• 160 beds in 4 independant units (Toronto)
• Restricted access drug-room with environmental control and monitoring
• Sample storage with continuous monitoring by the REES system
• In-house dedicated screening & recruiting capabilities
• Extensive subject database

Clinical Staff
We have 400+ dedicated staff members to support our clinical facilities and our medical team has over 40 experienced physicians in clinical research.

Our staff includes rigorous Quality Control and Quality Assurance teams to ensure the integrity of the data, a dedicated medical director at each site to ensure subject safety as well as a qualified team of medical specialists to complete any particular study requirements.

Recruiting/Database
We are continually expanding our already extensive study participant database in order to respond efficiently to our sponsors’ requests. This is achieved by having full time call centers at each of our clinical site. Our database allows us to perform extensive searches based on protocol specific parameters.

Regulatory Track Record
Regulatory agencies routinely audit our procedures and facilities, as well as the studies we oversee. Among them, the American, the Canadian, the Brazilian and French Agencies have recognized our strict adherence to regulations and the quality of our work. A detailed regulatory track record would be provided upon request.

With a complete range of early clinical and bioanalytical services, strong customer focus, and a total commitment to quality, responsiveness and timeliness; Anapharm can meet your drug development outsourcing needs

For a complete list of our offices, please visit www.pharmanet.com

Contact Information

Anapharm

Corporate Office
2500 Einstein
Québec, QC G1P 0A2 Canada
Phone: 418-527-4000
Fax: 418-527-3456
E-mail:

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