"We believe in a world where “culture of research” is developed within the system, which is based on basic fundamentals of integrity, openness and honest work"
GCP MONITOR is an organization established with an ambition of becoming the complete solutions provider organization to the clinical lifecycle related to monitoring, medical writing, auditing and document translation. GCP MONITOR has the expertise and resources to meet all clinical needs of clients. By using unique approaches GCP MONITOR provides customized solutions for small and midsize firms to global pharmaceutical companies in a way that meets timelines and saves cost while assuring the highest quality data possible.
We understand the regulatory, geo-political and economic environment for a speedy translation of research into practice. We have a highly qualified and dedicated team of clinical research professionals with a vibrant vision of the clinical trial industry and having an in-depth understanding of the domestic and international ethical and regulatory standards.
"Our mission is to deliver distinct service with the highest quality standards which in real helps to develop “culture of research” which is based on basic fundamentals of integrity, openness and honest work."
"GCP MONITOR is an organization established with an ambition of becoming the complete solutions provider organization to the clinical research related to Monitoring, Medical Writing, Auditing and Document Translation."
Good clinical practice is a guideline adopted internationally as standard operating procedure for conduct of clinical research. Despite these guidelines Scientific Misconduct is a reality which nobody can shy away from. Furthermore, clinical research is very vulnerable to Scientific Misconduct due to no effective mechanism in place for detecting, investigating and prosecuting Scientific Misconduct in most of the countries.
Good Clinical Practice (GCP) is an ethical and scientific international quality standard provided by the International Conference on Harmonisation (ICH) for designing, conducting, performing, monitoring, auditing, recording, analysing and reporting of clinical trials, or studies that involve the participation of human subjects.
Governments have transposed GCP into regulations for clinical trials. Compliance to this standard provides assurance to the public that clinical trial data and reported results are credible and accurate. It also demonstrates that the rights, safety, integrity, confidentiality and well being of trial subjects are protected, consistent with the principles enshrined in the Declaration of Helsinki.
GCP can add to the quality of work and help to establish the most efficient and effective way to adhere to its guidelines. As healthcare practitioners, physicians, scientists, and researchers, everyone wants safe and effective treatments for patients. Adherence to GCP is the best way to ensure this in a clinical trial. It is also in the best interests of the participants.
Conducting clinical research in accordance with the principles of GCP helps to ensure that participants in clinical research are not exposed to undue risk, and that data generated in the research is legitimate and correct. Thus, GCP serves not only the interest of clinicians and those involved in the research process, but also protects the rights, safety, and wellbeing of subjects at the same time as ensuring that investigations are scientifically sound and advance public health goals.
The principles of GCP state that: Each individual involved in conducting a trial should be qualified by EDUCATION, TRAINING AND EXPERIENCE to perform his or her respective task(s) as per the Guidelines for GCP. GCP training forms one component of the systems for ensuring high quality research. It’s a key requirement for anyone carrying out, or involved, in clinical research and clinical trials to ensure they are best prepared to carry out their duties.
GCP training provides the research community with insight into the rules and regulations that are applicable to clinical trials, highlights the roles and responsibilities of a principle investigator, the complexities of informed consent, personal information, storage of materials, etc. It serves as a basic education platform on the standards of practice for conducting research.
The training should be appropriate and proportionate to the type of research undertaken and should cover the responsibilities of researchers as they are set out in relevant legislation and standards. There is no set requirement for the frequency of such training. Researchers are expected to maintain awareness of current standards through reference to published guidance and relevant policies. Training should be updated when legislation has changed, new policies or practice have been implemented, different research activities are to be undertaken, or a significant period of time has elapsed since research activities have been conducted.
GCP Monitor's Training program includes GCP TRAINING, GLP TRAINING, GDP TRAINING, Electronic Submission Standards