Partner DO-HEALTH – Clinical Monitoring
Marieme Ba has a Master of Immunology, Bachelor of Sciences, and business school degree. She has 17 years of experience in the pharmaceutical industry with 14 years spent in small and large Contract Research Organisations and mid size pharmaceutical companies. She started as a monitor, and then was nominated Clinical Research Manager. She is the founder of Pharmalys Ltd that was created 4 years ago.
Pharmalys is a UK-based Contract Research Organisation (CRO) with extensive expertise across a wide range of therapeutic areas. Pharmalys provides innovative solutions throughout Europe and covers all clinical trial phases in a proactive and cost-conscious way. They manage local and international projects from the trial feasibility assessment right through to study reporting for small or large projects.
As the DO-HEALTH independent clinical monitoring partner, Pharmalys ensured that at all recruitment sites, SOPs were followed and all data collection and adverse event documentation was according to Good Clinical Practice. All sites have been thoroughly trained prior to the enrolment of their first participant. After the training, regular site monitor visits occured for all 4 clinical visits followed by a close-out visit at the end of the trial. Pharmalys supported the recruitment centers in the application for each country’s ethical and competent authority authorization for the clinical trial. Pharmalys wrote an ongoing report of Adverse Events to the data safety and monitoring board and reviewed at each site visit, the ongoing collection and maintenance of study master files.