Regulatory Compliance

Our Regulatory Compliance Plan for clinical research in Canada ensures that all aspects of our studies adhere to the stringent regulatory requirements set forth by Canadian authorities.

We provide guidance and support to ensure clinical trials comply with all relevant regulatory requirements, including those set by HC, FDA, EMA, and other regulatory bodies.

Our knowledgeable regulatory affairs team is proficient in the regulatory requirements of Health Canada, FDA, EMA, and global agencies, providing comprehensive support in study applications, submissions, approvals, and clinical trial authorization (CTA) applications. With an in-house quality assurance team and adherence to standard operating procedures (SOPs), we consistently meet rigorous regulatory and quality standards.

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Canadian Regulations
Ensure

that all clinical research activities at the site are conducted per the relevant Canadian laws and regulations, such as the Food and Drugs Act and its Regulations, the Tri-Council Policy Statement, and the Personal Information Protection and Electronic Documents Act.

Institutional Review Board (IRB) or Research Ethics Board (REB)

All research involving human participants requires approval from an IRB, a committee that reviews and approves the study design, informed consent documents, and other study-related documents. The plan should outline the procedures for submitting and obtaining IRB approval for each study conducted at the site.

 

Regulatory Compliance - MC Research Service

With a meticulous approach, we navigate through the complex landscape of regulations to ensure ethical conduct, participant safety, and data integrity, providing our clients with the confidence and assurance they need for successful and compliant clinical research endeavours in Canada. We also provide guidance and support to ensure clinical trials comply with all relevant regulatory requirements, including those set by HC, FDA, EMA, and other regulatory bodies.

What our clients and participants have to say

MC Research truly exceeded my expectations. Their commitment to delivering top-notch clinical research services while putting patients first is remarkable. I am grateful to have been a part of their study and contribute to the advancement of medical treatments.
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Emily R. September 25, 2022
Choosing MC Research for my clinical research study was the best decision I made. Their dedication to prioritizing patient needs while delivering exceptional services sets them apart. The team's expertise and passion for improving lives through safe therapies are evident throughout the entire process. Thank you for making a difference!
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David S. March 21, 2020
MC Research embodies excellence in clinical research. Their commitment to the highest standards, patient well-being, and advancing medical treatments is truly inspiring. Participating in their study was not only an opportunity for me but a chance to contribute to the betterment of healthcare. I wholeheartedly recommend their services.
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Jessica S. January 07, 2023