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.

Training Sheet

Training ICH-GCP

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.

Training sheet

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:

• Regulation;
• 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

Training sheet

Safety training

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.

Training sheet

Local Regulation

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

Training sheet

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.

Training sheet

We always aim to develop and implement the patient’s recruitment and retention program from the project start to guarantee and ensure that recruitment targets are achieved. Some of the suggestions to improve patient retention rates in clinical trials are:

• Set up an educational and didactic program for the patients,
• Set up a reminder and follow-up system in the context of ongoing trials, through various means, including applications and other digital tools.

According to the WHO, therapeutic education for patients is intended to help patients acquire or maintain the skills they need to optimally manage to live with a chronic disease by:

• Understand his illness and the prescribed treatment;
• Live as healthy as possible;
• Maintain or improve the quality of life;
• Become aware and calmly manage their health.

We have the scientific and medical knowledge and expertise to assist you in your projects. Our experience in clinical development in different therapeutic areas allows us to address different scientific items.
We provide real expertise in piloting your clinical research projects :

• Phase II to IV clinical trials;
• Feasibility studies;
• Observational Studies & Surveys;
• Post-Marketing studies;

We also can support you the following services :

• Project Management;
• Pharmacovigilance: monitoring of activities in clinical trials, risk management plans;
• Medical support as part of the establishment of Temporary Authorizations for Use (ATU);
• Medical Writing (Protocol and Synospsis; Clinical Study Report; Observational study report, etc..).

• Our expertise enables us to offer you turnkey projects in order to evaluate the transposition of data from clinical studies to real life;
• Evaluation and study of the impact of diseases on the quality of life of patients taking into account the geographical and economic context;
• Estimating the size of a target population;
• Frequency, Incidence and prevalence of disease;
• We propose different methodological approaches in order to provide the design that best suits the objectives of your studies:
  • Cross-sectional or longitudinal study;
  • Cohort study, control cases;
  • Register and survey;
  • Economic models (cost-effectiveness and budget impact models).

We provide a high-quality response to all your medical issues to achieve the strategic goals of your organization.
We build for you a customized support, tailored to your needs throughout your product lifecycle.

We work on the following tasks:

• Control and support in the design of promotional materials and claims;
• Review of safety data;
• Implementation and Management of Advisory – Experts Boards;
• Medical Information (Response to medical questions with documented bibliographic clarification);
• Drafting of briefing notes and information at congresses and other scientific events;
• Bibliographical monitoring and updating of medical and scientific knowledge.

Market Access is an important component of health economics. This is a mandatory step that ensures the access to market of health products with the highest standards of pricing and reimbursement. We assist companies in the various stages of this process:

• Market access strategy;
• Advice and implementation of registration strategies;
• Liaison with Health Authorities: consultation meetings, requests for scientific advice;
• Preparation and writing of Economic from.