Axelys santé DZ delivers training in clinical research and medical writing. The list includes but is not limited to:
Clinical Research Associate training
The Clinical Research Associate (CRA) is a key in the follow-up of a trial or clinical study. The CRA is the link between the sponsor and the investigator in charge of carrying out the clinical trial on the investigation site (hospital or medical practice). The CRA is responsible for the quality, reliability and authenticity of patient data collected by the investigator in the clinical study.
- Master the ethical and technical-regulatory principles of studies involving the human person;
- To know how to use the essential documents of the study [Trial Master File (TMF), investigator file etc …], to learn to respect and make respect the standard operating procedures (SOPs) in force;
- Conduct on-site monitoring visits from the site selection to site closures in compliance with local regulations.
This training is updated regularly based on regulatory updates.
Good Clinical Practice is a set of requirements and provisions to be put in place to ensure the quality of clinical trials.
Recognized internationally, they have been developed to standardize the conduct of clinical trials and provide guarantees on two fundamental aspects:
- Ethics, on the one hand, thanks to the respect of the rights, the integrity and the confidentiality of the personal data,
- Scientific on the other hand, ensuring that the data obtained in the tests are authentic, reliable and verifiable.
All actors involved in conducting clinical trials of medicinal products for human use should take into account this set of requirements.
This training presents a concrete application of GCP to enable you to carry out your clinical trials according to internationally recognized quality standards and with a view to compliance.
Protocol, synopsis writing, and study design
Writing a clinical trial protocol or post-marketing study follows specific rules. The editor must refer to a methodology specific to the drafting of such documents. This training allows scientific or medical profiles to acquire real skills.
This training follows the various standards of protocol writing: it is articulated around the following topics:
- Content of the synopsis and the protocol;
- Rationale for each paragraph and part of the synopsis and protocol;
- Prioritization of key points;
- Management of the scientific committee and/or the steering committee of the trial;
- Informed Consent and Briefing Note
- Management of amendments to the protocol
The Safety or pharmacovigilance aims to ensure and guarantee the safety of use and the rules of good use in the use of medicines.
The evaluation and monitoring of the risks associated with the use of the drug are major issues for pharmaceutical companies. This surveillance is done before and after the marketing of the drug. Pharmacovigilance is exercised through various missions, such as case capture, case validation, and participation in the preparation of pharmacovigilance reports or signal detection.
This training is specially designed for health or clinical research actors who need to develop and master both theoretical and operational skills, to evolve towards this profession.
The objective of this training is to know and master the regulations and standards associated with it in the clinical practice management of clinical trials. The training is articulated around the following topics:
- Context and regulatory evolution in Algeria.
- Declaration of Helsinki (2013)
- Ethics, ethics and good practices rules
Conduct of Clinical Trials (Project Manager)
The Clinical Project Manager coordinates the different stakeholders of the clinical research project and ensures the smooth running of the studies in accordance with the protocol, the regulations, and the procedures, from the conception of the documents (protocol, CRF, site documents …) until site closure
He is also in charge of the financial follow-up of the project, the respect of the specifications and the schedule.