GCP audits (remote and onsite)
Why do we need strict rules to run clinical trials?
There have been several shameful moments in history, when humans became the objects of uncontrolled, unsupervised and unethical experiments. To prevent this from happening again, human trials are now submitted to strict control of Competent Authorities and Ethics Committees. They are minutely assessed before they begin and carefully monitored throughout their course. The data obtained are meticulously verified at each step of the study. All these activities are regulated by the set of rules known as Good Clinical Practice (GCP).
It all started with the Declaration of Helsinki – a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA). The Association, since its beginning in 1947, works on ensuring ethical conduct in medical practices. The Declaration of Helsinki, although it is not a legally binding document, is morally binding on physicians, to apply in their work the highest ethical standards. The spirit of the Declaration of Helsinki has been adopted later on in the guidelines of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and guidelines of international (e.g. European Medicines Agency, EMA) and national Competent Authorities and imposed upon clinical study sponsors, investigators and other parties involved by appropriate legal acts.
The principles of GCP
The GCP focuses on two main aspects:
- the safety of subjects involved in clinical trials, the respect for their rights and wellbeing
- high quality of the data obtained during the trials.
Strict rules have been developed on keeping high standards in terms of e.g. the documentation of trials, data recording, record keeping, training of study personnel. Much emphasis is put on informing the trial participants of the details of the trial and obtaining their informed consent.
Particular attention is also put on vulnerable populations, such as patients, who are physically or mentally incapable of giving consent, or minors. The overall aim is to allow the conduct of experiments with human subjects, while at the same time assuring their safety, respecting their decisions and collecting high quality data, so the studies would not need repetition.
GCP audits
Among many others, SciencePharma provides services as the Contract Research Organization (CRO) for clinical trials. We are therefore fully aware and always up-to-date with the GCP requirements, and we have the expertise to verify whether other companies comply with them as well. GCP audits in clinical trials of medicinal products, as well as medical devices, are indispensable elements of the quality assurance system, which must be ensured by each sponsor conducting a clinical trial. If you do not have the resource to do it yourselves, we can do it for you.
The audits can be performed remotely, or on-site, with the on-site visits providing more insight.
SciencePharma has a qualified team of GCP auditors, who can perform independent assessment of CROs pre-selected for running the clinical trial(s), or the assessment of the already on-going clinical trial(s). We can help you in selecting the CRO to perform your study, or verify if the already selected CRO runs the trial appropriately. Our services include (but are not limited to):
- Verification of Standard operating procedures (SOPs) and quality documents;
- Qualification of potential vendors;
- Verification of processes or contracting activities;
- Clinical trial audits (during conduct or after completion);
- Preventive or correction actions suggestions.
It would be such a pity to miss the Marketing Authorization only because of some formal allegations over the quality of your pivotal clinical trial(s). Choose our auditors and we will help you mitigate that risk.