Clinical Opreation
Evanjo offers expert clinical operations services, including clinical monitoring, site management, project management, and regulatory intelligence. Our team ensures compliance with ICH E6 – GCP and local regulations, delivering seamless trial execution across MENA and Africa with a focus on quality and efficiency.
Medical Devices
Specializing in medical device and diagnostic clinical development, Evanjo conducts trials for Class IIa, IIb, III, and Active Implantable Medical Devices (AIMD) across the MENA and Africa region. Our experts collaborate with your team to design and execute high-quality trials.
Medical Writing
Evanjo’s medical writing services cover study protocols, investigator brochures, informed consent documents, and more. Our professional team delivers precise, compliant documentation, including advisory board reports and publications, tailored to your needs.
Data mangment
Our data management services include developing data plans, database setup, data cleaning, and query management. Evanjo ensures accurate, secure data handling compliant with international standards for your clinical trials.
Biostatstics
Evanjo provides full biostatistical support, from protocol design to result dissemination, adhering to ICH E9 (R1) & E3 guidelines. Our statisticians offer expert analysis across all therapeutic areas for robust trial outcomes.
Pharmacovigilance
Evanjo’s pharmacovigilance services include SAE processing, safety reporting, and document preparation like PSURs and RMPs. We ensure compliance with local and international regulations to safeguard trial participants.
Regulatory intelligence
Evanjo’s Regulatory Affairs services specialize in navigating the complex regulatory landscape across MENA and Africa. We provide comprehensive regulatory intelligence, including creation of CTD & e-CTD dossiers, drug supply and importation processes, and GxP audit support. Our expertise extends to full clinical trial application (CTA) submissions to local authorities such as Egypt’s Central Administration of Pharmaceutical Affairs, Saudi FDA (SFDA), UAE’s MoHAP, and South Africa’s SAHPRA. Leveraging established contacts and local knowledge, we expedite approvals, ensure ICH-GCP compliance, conduct pre-submission consultations, and mitigate risks to minimize delays from study start-up to completion—delivering cost-effective solutions tailored to your trials.