WELCOME IN CANADA CRS

PATIENT SAFETY, QUALITY, COMPLIANCE

About CANADA CRS

Canada CRS was founded in 2017 by a dedicated team of Health Care Proffessionals with more than 15 years of experience in pharmacovigilance with a mission to ensure patient safety, quality of the data and compliance toward health authorities agencies.

WHAT WE DO?

Provide pharmacovigilance services and expertise to meet the complex regulatory requirements in pharmacovigilance, which is subjected to recent updates.
Manage the pharmacovigilance tasks that are required during the medicinal products’ life cycle with full coverage for product safety from Phase I to IV clinical studies relevant across a broad spectrum of therapeutic areas.
Ensure effective collaboration with Marketing Authorisation Applicants / holders (MAA / MAH), providing flexible solutions to manage dedicated tasks with ensured compliance and adherence to authorities’ régulations.

OUR GOAL

Ensure Canada CRS provides a precise and tailored service that will make us the “partner of choice” with all collaborators, regulators, service providers, safety physicians and pharmacist services.

OUR OBJECTIVE

Provide compliant, confidential services that correspond to your needs. Projects performed according to ICH-GPV standard and international regulatory requirements.

Our Services

Dedicated team of Health Care Professional with experience in the pharmaceutical industry and health authorities in Europe and North America.

PHARMACOVIGILANCE

Our Services are designed to support Industry, Biotech, CROs and Hospitals in all Pharmacovigilance activities (Drugs and Medical Devices) to meet their Local, Global and Regulatory Pharmacovigilance requirements and compliance.

  • Pharmacovigilance Training
  • PV Systems
  • ICSRs Processing
  • Aggregate Safety Reports
  • Risk Management Plan
  • Safety Signal Detection
  • Literature Research
  • Social Media Monitoring
  • Audits and inspections

CLINICAL RESEARCH

Canada CRS experienced team and its partners will support and assist Sponsors and Sites with:

  • Protocol Writing
  • Biostatistics
  • regulatory guidance and insight
  • Protocol Design
  • Investigational Sites Recruitment and Coordination.

REGULATORY AFFAIRS

Canada CRS regulatory affairs staff provides expert consulting and assistance to ensure that you are in compliance with the requirements of Regulatory Agencies (RA):

  • Local Primary Point of contact with RA
  • Clinical Trial Submissions (CTA, IND)
  • Regulations and guidelines governing Clinical Trials and Post-marketing
  • Compliance audit services Maintenance and archiving of documents

Contact Us

Please leave your message and we will get back to you as soon as we can.

4388, rue St Denis
Suite 200 # 382
H2J 2L1
Montréal, Qc
Canada

info@canadacrs.ca

Votre message a etait envoyé. Merci !