A qualified team, proficient in three main languages: French, English and Arab, writes scientific and medical documents in accordance with international standards (ICH-GCP) while meeting the strategic requirements of our customers.

We write:
- Synopses and Protocols
- Clinical trial feasibility questionnaires
- Patient information notes and informed consent forms
- Case Report Forms (CRF)
- Monitoring plans
- Risk management plans
- Data Management Plans
- Clinical trial reports
- Newsletters and News Flashes
- Publications: Abstracts, posters and scientific articles in English and French

With full knowledge of local legislation and expertise in regulatory procedures governing interventional and observational studies, our teams:

- Compile applications
- Revise and proofread documents (Quality Assurance Department)
- Submit and follow-up on applications for opinions to Ethics Committees
- Submit and follow-up on applications for opinions to the Ministry of Health

A team of professionals manages the operational and technical aspects of the following tasks:

- Feasibility visits
- Site selection
- Project team training (investigators, nurses & trial technicians)
- Initiation, monitoring and site close-out visits
- Logistics
- TU import, storage and management.
- Management of the various service providers working on studies

- Pharmacovigilance plan compilation
- Monitoring and reporting of serious adverse events to the Ethics Committee, to the Ministry of Health and to the study sponsor.
- Notification of SUSARs/PSURs to investigators, to the Ethics Committee and to the Ministry of Health

- Data management plan compilation
- Creation of databases according to international standards
- Single and double data entry
- Coding according to international dictionaries
- Data review
- Edition of queries
- Creation of statistical analyses plans
- Drafting of statistics and clinical reports

Training topics:
- Regulatory training (ICH-GCP, GPP, local legislation etc.)
- Clinical Operations Training (SIV, MV, COV, TU management, patient consent, randomisation, anticorruption etc.)
- Medical writing training
- Pharmacovigilance training
- Data management / Biostatistics training

Initial and in-house training of Clinical Research Associates
Training of health care professionals and pharmaceutical partners