GCP Consulting for drugs, NHPs, cannabis & extracts

GCP Consulting services for drugs, cannabis (marijuana), NHPs, and Novel Foods in Canada

GCP – Good Clinical Practices compliance as per Division 5 (Part C) of Health Canada’s Food and Drug Regulations

GCP Consulting ServicesOur GCP Consulting Services

What Specific GCP Requirements can ICS Assist With?

What are the Principles of GCP?

Our GCP Consulting Services

We can act as an impartial third party to help ensure the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of the clinical trial, to provide assurance that the data & reported results are credible & accurate, and that the rights, integrity & confidentiality of trial subjects are protected. Even if you are working with a Clinical Research Organisation (CRO), we can help you ensure that your best interests as the Sponsor are taken assured throughout.

Based on the various HPFBI & ICH guidance documents, we have developed numerous Protocols, SOPs and audit checklists to help clinical trail sponsors ensure compliance to the principles & practices of GCP. We also review the latest list of common deficiencies cited in the Summary Reports of Inspections of Clinical Trials Conducted.

See our CT application services page, QA Implementation services page, QA auditing web page, and Adverse Reaction Reporting web page for other information, as well as on our cannabis extracts page.

What Specific GCP Requirements can ICS Assist With?

     SPONSOR

  • Quality Assurance (QA) & Quality Control (QC)
  • Working with Contract Research Organization (CRO)
  • Trial Management, Data Handling, and Record Keeping
  • Investigator Selection
  • Allocation of Responsibilities
  • Information on Investigational Product(s)
  • Manufacturing, Packaging, Labelling, and Coding Investigational Product(s)
  • Supplying and Handling Investigational Product(s)
  • Record Access
  • Safety Information
  • Adverse Drug Reaction Reporting to GVP (Good Pharmacovigilance Practices)
  • Monitoring
  • Audit

     INSTITUTIONAL REVIEW BOARD / INDEPENDENT ETHICS COMMITTEE (IRB/IEC)

  • Responsibilities
  • Composition, Functions and Operations
  • Procedures
  • Records

     INVESTIGATOR

  • Qualifications & Agreements
  • Adequate Resources
  • Medical Care of Trial Subjects
  • Communication with IRB/IEC
  • Compliance with Protocol
  • Investigational Product(s)
  • Randomization Procedures and Unblinding
  • Informed Consent of Trial Subjects
  • Records & Reports
  • Progress Reports
  • Safety Reporting
  • Premature Termination or Suspension of a Trial
  • Final Report(s) by Investigator

What are the Principles of GCP?

  • Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
    • .
  • Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
    • .
  • The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
    • .
  • The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
    • .
  • Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
    • .
  • A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval / favourable opinion.
    • .
  • The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
    • .
  • Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
    • .
  • Freely given informed consent should be obtained from every subject prior to clinical trial participation.
    • .
  • All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
    • .
  • The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
    • .
  • Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
    • .
  • Systems with procedures that assure the quality of every aspect of the trial should be implemented

 

Why use a consultant?

Weighing the numerous pros & cons of bringing in a consultant vs. tackling it all in-house?  Please see our web pageWhy Use a Consultantas part of that critical thinking process. Based in British Columbia, but covering all of Western Canada.


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