What are Comprehensive Good Clinical Practice (GCP) Services?
Comprehend and follow the Good Clinical Practice (GCP) guidelines is essential to the completion of a trial investigation that aims introducing a new medical device to the market. When necessary, performing a clinical trial can be a long and nuanced process, that’s why partnering with an experienced Contract Reseach Organization can save manufactures time and money.
Organisations that may have to comply with GCP include:
- Pharmaceutical companies
- Contract Research Organisations
- NHS hospitals
- GP practices
- Laboratories analysing samples originating from a clinical trial (including NHS, academic and commercial laboratories)
Our comprehensive GCP services ensure that your clinical trials are conducted in compliance with the highest standards of quality and integrity. We have a team of experts who specialize in clinical trials and regulatory affairs that are ready to work alongside your professionals to attend your medical devices needs.
Learn more about how ECLEVAR can help you following the guidelines for Good Clinical Practice in the article below.
What is Good Clinical Practice?
As an international ethical and scientific quality standard for clinical trials procedures involving human subjects, the guidelines designed for Good Clinical Practice ensures safety regarding public well-being.
European Union, Japan, and the United States, as well as of Australia, Canada and the Nordic countries, must comply with the indicated protocols when generating clinical trial data that are intended to be submitted to regulatory authorities.
Besides ethical principles, following GPC is required to complete the series of trials and investigations needed for some medical devices to enter the market in any country (even with regulatory differences between them).
Guideline for good practice in clinical trials
The guideline (presented in its completion here), produced by the international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH), designs very detailed protocols for clinical trials and medical products investigations, directed both to the investigator and sponsor throughout the entirety of the evaluation process.
Before the trial initiation, possible risks and inconveniences, as well as potential benefits, to everyone involved as a subject, must be indicated. It’s most important that each participant understands the process and its consequences, for the safety and well-being of the trial subjects are considerations that should prevail over interests of science and society.
World Health Organization Principles of GCP
WHO has stipulated principles for GCP, that include:
- All research must be described in writing and must contain clear detailed protocol, and scientifical justification.
- Expected benefits for the individual research subject and society must clearly outweigh the risks.
- Research that involves humans must be approved by the independent ethics committee/institutional review board (IEC/IRB) prior to initiation.
- Freely given informed consent should be collected from each individual research subject prior to research.
- Qualified medical personnel must be responsible for the health of each patient involved in the trial, and always make decisions on behalf of the individuals.
- All clinical trial information should be documented, handled, and stored in a way that allows accurate reporting, interpretation, and verification.
You can read the entire list of principles at the Handbook for Good Clinical Practice.
Clinica trial functions can be extended to CROs
A sponsor may transfer any or all trial-related duties and functions to a CRO before the investigations begin, but the ultimate responsibility for the quality and integrity of the data collected lays always upon the sponsor. The CRO should implement quality assurance and quality control through specializes personal and knowledgeable conduct.
That being said, the sponsor must be certain that the team advising and performing the study is in fact appropriate and qualified medical personal. Choosing the right CRO to accompany the clinical trial is a matter of finding the one with experience in similar medical field as the device in question and also the one that is the most familiar with the target market’s regulatory path.
ECLEVAR offers you expertise in CRO services and Good Clinical Practice
Contact us to know more about our Good Clinical Practice compliance and how we can help your medical device reach your target market with safety and effectiveness.