MENA and Africa Challenges & Solutions

Approvals: 

The regulatory landscape is rather complex and obtaining approvals can be time consuming. A local expertise is vital to expedite approval timelines. MarPe has the necessary current working knowledge of the diverse regulations as well as established contacts with the authorities to minimize delays from the study start-up to its end.

Compliance: 

MarPe's strategic planning helps its clients to overcome challenges in regulatory compliance and study oversight. Potential risks related to study integrity, data quality, and volunteers’ protection are identified, analyzed and mitigated using a risk-based approach to study conduct and monitoring.

Recruitment:  

Growing healthcare infrastructures and communication technologies facilitate patients’ recruitment. Low operating costs compared to the USA and the Western countries combined with the increase in pharmaceutical sales provide incentives for further boost of clinical trials allocated to the region.

Training:

The growing number of clinical trials conducted in the MENA region requires all involved personnel to be adequately trained to work on increasingly complex studies. Training focuses on achieving and maintaining adequate quality in clinical trials as well as on adherence to local and international guidelines. MarPe provides clinical research trainers who deliver the basic training on quality assurance, regulatory requirements, and monitoring to new clinical research staff that is crucial for their work. For experienced clinical research personnel, advanced training sessions provide an opportunity to refresh knowledge and keep abreast of regulatory changes. MarPe has developed comprehensive training courses covering all facets of clinical research.