Download Clinical Trials in Canada: The Algorithme Pharma Advantage

Clinical Trials in Canada:
The Algorithme Pharma Advantage
Accelerating the development of medications that improve the quality of life is in everyone’s interest, especially
when they are the first available treatment or have advantages over existing treatments. Conducting early phase
clinical trials with Algorithme Pharma benefits pharmaceutical and biotechnology companies by accelerating
the study-start timelines by over 40%. This advantage over North American industry standards is made possible
through the combination of efficient processes at Algorithme Pharma and the favorable Canadian clinical research
environment.
ACCELERATED TIMELINES WITH ALGORITHME PHARMA
When considering placement of early phase clinical trials in Canada, a clear understanding of the submissions
needed for the study-start process can allow companies to benefit from Canadian clinical trial timelines. To fully
leverage these timelines, Algorithme Pharma routinely manages the complete process for our clients.
In planning a First-In-Human (FIH) trial of a New Chemical Entity (NCE) in Canada, a Clinical Trial Application (CTA)
must be submitted to the Therapeutics Products Directorate (TPD) at Health Canada. There are minor differences in
submission requirements in addition to the advantageous timelines when comparing the Canadian CTA to the U.S.
Investigational New Drug (IND) application (see Table 1).
With the accelerated internal processes available at Algorithme Pharma, plus the more favorable regulatory environment, our data shows a CTA mean approval timeline of 21 days, versus a 30-day approval timeline for INDs
(Clinical Phase I Trials).
Clinical Phase 1 Pre-Study Timelines (days) US CRO & Algorithme Pharma
US Standard
(Series Schedule)
Algorithme Pharma
(Parallel Schedule)
IND Submission
CTA Submission
Recruitment / Screening
Institutional Review Board
Recruitment / Screening
Total Pre-Study Timeline
Another significant advantage to conducting clinical trials with Algorithme Pharma in Canada over a U.S. CRO is
that the participant recruitment and screening can be performed while waiting for approval of the CTA. When this
efficiency is added to the CTA submission timeline, the total study-start acceleration is up to 25 days resulting in a
timeline reduction of over 40% (as illustrated in the chart above).
Table 1: Outline of Regulatory Submission Differences between
CTA and IND for First-In-Human Trial
Module
Canadian CTA
United States IND
1. Administrative information
(country specific information
such as submission forms)
Health Canada Forms
FDA Forms
Investigator’s Brochure
Investigator’s Brochure
Protocol Synopsis (PSEAT-CTA)
General Investigational Plan
Protocol and Informed Consent Form
2. CTD summaries
(includes manufacturing
summaries & nonclinical data)
Quality Overall Summary (QOS)
Some Sponsors will include QOS, though
Module 3 (full manufacturing data) is preferred.
3.Quality
(full manufacturing data)
Not Required
Required
4. Nonclinical reports
Not Required (summaries only)
Required
5. Clinical reports & Publications
Not Required
Required (if any)
Nonclinical summary
Protocol and Informed Consent submitted
in Module 5 (Clinical reports and publications)
Source: Biotechnology Focus – April 2012
CLINICAL RESEARCH QUALITY IN CANADA
Canada is home to many reputable clinical research teams experienced in managing complex, international studies. This research
community is supported by common health research networks
and strong information-management systems. Combined, this
platform has developed Canada’s reputation for exceeding
industry standards in meeting recruitment targets and generating
high-quality results to meet the requirements of international
regulatory agencies.
Algorithme Pharma has an exemplary regulatory history with
successful inspections by Health Canada, USA’s FDA, Brazil’s
ANVISA, France’s ANSM, United Kingdom’s MHRA, Austria’s AGES,
Spain’s AEMPS, Standards Council of Canada, and the Ministry
of Public Health in Thailand. This proven track record has led
Algorithme Pharma to earn a reputation in the industry for
high-quality and reliable results.
UNIVERSAL HEALTH CARE: DELIVERING
EARLY PHASE CLINICAL TRIAL ADVANTAGES
Health care in Canada is delivered through a publicly funded
Medicare system, which is administered universally and free at
the point of use. This initiative is supported by the Government
of Canada and managed by each province individually. The
intent is to assure a “continuum of care” across the country.
This healthcare management philosophy has allowed pharmaceutical and biotechno­logy communities to leverage the high
quality of participant health for pivotal early phase clinical
trials. The continuum of care means patient health is properly
managed and makes recruiting for trials more efficient. Combined with Algorithme Pharma’s active participant list of over
40,000 healthy participants, recruitment levels and timelines
far exceed industry standards and ensure on time study-starts.
Algorithme Pharma’s 2012 average recruitment performance
was 98% with almost 7,000 participants enrolled.
THERAPEUTIC AREA PATIENT POPULATIONS
Each therapeutic area presents its own unique challenges for early stage clinical trials. Algorithme Pharma’s
integrated network of scientific and regulatory experts have in-depth experience in designing optimized
study protocols and accessing patient populations to enable quicker “go/no-go” decisions.
Clinical Trials in Canada by Therapeutic Area
Infectious Disease 9%
Central Nervous Disease 12%
Diabetes 7%
Immunology 2%
Inflammation 2%
Cardiovascular
Disease 13%
Other 14%
Oncology 41%
Source: clincaltrials.gov
Partnering with Algorithme Pharma has benefited many pharmaceutical and biotechnology companies in
accelerating their clinical trial timelines. The effective combination of the Canadian clinical research
environment and Algorithme Pharma’s efficient operational procedures, delivers a measurable advantage
over industry standards.
To request more information, please contact us at [email protected]
F
ounded in 1992, Algorithme Pharma is an established early stage clinical contract
research organization (CRO) providing multiple research services for pharmaceutical,
biotechnology and generic drug industries.
Algorithme Pharma’s facilities include a 6-unit clinic with 224 beds and a 20,000 square
foot Bioanalytical laboratory.
With over 20 years’ experience in clinical research, Algorithme Pharma successfully
completes over 200 clinical trials annually in Phase I/IIa and Bioequivalence. Combined
with Algorithme Pharma’s active participant list of over 40,000 healthy participants,
recruitment levels and timelines far exceed industry standards and ensure on-time
study starts. In addition, our network of specialized clinicians and relationships with local
hospitals provides access to a wide range of patient populations.
Furthermore, Algorithme Pharma performs large and small molecule bioanalysis on
samples from Preclinical to Phase IV studies. The organization is comprised of almost 500
professionals from the medical and scientific fields who work together to provide quality
input into study design, conduct and reporting in a wide range of therapeutic areas.
Global Access to Patient Populations
- Chronic heart disease
- CNS Diseases
- Ophthalmic diseases
- Asthma
- Hypertension
- Rheumatoid Arthritis
- Chronic obstructive pulmonary
disease (COPD)
- Dermatological diseases
- Hepatitis
- Diabetes mellitus (type I & type II)
- Thyroid
- Gastrointestinal Disease
- Renal failure
Bioanalytical Support
Specialities:
- Preclinical
- Biomarker quantification
- Ligand Binding Assays
- Clinical Phase I – IV
- Dried Blood Spot Analysis
- Metabolite ID
- Bioequivalence
- Drug-Drug Interactions
- Protein Binding
- Endogenous compounds
- Tissue Analysis
Printed in Canada
2013/04/04
- Large Molecule Quantification
by LC- MS/MS
ALTASCIENCES COMPANY Inc.
ALGORITHME PHARMA
www.altasciences.com
Tel.: (450) 973-6077
Toll free: 1-888-267-7449
[email protected]