Pharmalys
Pharmalys is a Contract Research Organisation dedicated to advancing health outcomes through data excellence, high-quality clinical research, and strategic partnerships. Operating across Europe, Africa, and beyond, it supports sponsors worldwide in conducting ethical, innovative, and high-standard clinical trials. The company emphasizes capacity building, regulatory support, inclusive research practices, and technological innovation to foster sustainable health solutions and global health initiatives.
Industries
Nr. of Employees
small (1-50)
Pharmalys
Products
Pharmalys Technology Platform
A reliable and powerful software suite enabling project data access and visibility for stakeholders, ensuring high-quality data throughout clinical projects, compliant with FDA recommendations for IT systems in clinical trials.
Quality Assurance Services
Pharmalys performs audits at all stages and on all processes used in the management of clinical trials and health related studies to assess adherence and compliance with SOPs, GCP, regulatory requirements, study protocols, client instructions and contractual obligations.
Implementation Research
Pharmalys offers Implementation Research services to identify and address context-specific barriers in the deployment of health interventions, supporting successful application and scale-up within health systems.
Project Management
Dedicated Project Managers providing planning, coordination, risk management, and reporting throughout clinical trial projects.
Clinical Monitoring
Professional Clinical Research Associates (CRAs) providing site identification, qualification, monitoring, and reporting services in compliance with ICH/GCP standards.
Regulatory Affairs Services
Management of clinical trial applications and liaison with Ethics Committees, Competent Authorities, and Ministries of Health to ensure timely regulatory approvals.
Pharmalys Technology Platform
A reliable and powerful software suite enabling project data access and visibility for stakeholders, ensuring high-quality data throughout clinical projects, compliant with FDA recommendations for IT systems in clinical trials.
Quality Assurance Services
Pharmalys performs audits at all stages and on all processes used in the management of clinical trials and health related studies to assess adherence and compliance with SOPs, GCP, regulatory requirements, study protocols, client instructions and contractual obligations.
Implementation Research
Pharmalys offers Implementation Research services to identify and address context-specific barriers in the deployment of health interventions, supporting successful application and scale-up within health systems.
Project Management
Dedicated Project Managers providing planning, coordination, risk management, and reporting throughout clinical trial projects.
Clinical Monitoring
Professional Clinical Research Associates (CRAs) providing site identification, qualification, monitoring, and reporting services in compliance with ICH/GCP standards.
Regulatory Affairs Services
Management of clinical trial applications and liaison with Ethics Committees, Competent Authorities, and Ministries of Health to ensure timely regulatory approvals.
Services
Monitoring and inspection services for clinical trials including on-site and remote monitoring and document inspections to ensure GCP compliance.
Clinical project management covering planning, coordination and operational delivery of interventional and observational studies.
Clinical safety oversight, medical review, adverse event management and medical writing support across the study lifecycle.
Regulatory strategy development, preparation and submission of clinical trial applications, liaising with ethics committees and national authorities, import licensing and translation support.
Operational feasibility studies and site evaluation to assess capability, patient availability and local operational considerations.
Quality systems review, SOP development, mock inspections and audit support to ensure compliance with international research standards.
Monitoring and inspection services for clinical trials including on-site and remote monitoring and document inspections to ensure GCP compliance.
Clinical project management covering planning, coordination and operational delivery of interventional and observational studies.
Clinical safety oversight, medical review, adverse event management and medical writing support across the study lifecycle.
Regulatory strategy development, preparation and submission of clinical trial applications, liaising with ethics committees and national authorities, import licensing and translation support.
Operational feasibility studies and site evaluation to assess capability, patient availability and local operational considerations.
Quality systems review, SOP development, mock inspections and audit support to ensure compliance with international research standards.
Expertise Areas
- Clinical trial management
- Study start-up and site activation
- Regulatory affairs and submissions
- GCLP accreditation and laboratory quality
Key Technologies
- Electronic data capture (EDC)
- Cloud-based project platforms
- Webinar and e-learning platforms
- Clinical data management systems
News & Updates
Participation in a key gathering of clinical research professionals across Africa, highlighting progress and ongoing efforts in the continent's research landscape.
Pharmalys takes over full management of the Good Clinical Laboratory Practice (GCLP) Accreditation Scheme, emphasizing its commitment to quality standards in clinical laboratories.
Celebrating Senegal as the first Francophone African country to reach WHO Maturity Level 3, enhancing patient understanding and ethical standards.
Capacity-building training sessions conducted across four clinical research sites, focusing on equipping staff with essential skills.
A reflection on the growth, challenges, and achievements of Pharmalys over the past year, highlighting the role of community health workers, multicultural environment, and team support.
Insights from Arthur Makadi on his role, the company's mission, technological innovations, and his personal commitment to advancing global health through research.
Participation in a key gathering of clinical research professionals across Africa, highlighting progress and ongoing efforts in the continent's research landscape.
Pharmalys takes over full management of the Good Clinical Laboratory Practice (GCLP) Accreditation Scheme, emphasizing its commitment to quality standards in clinical laboratories.
Celebrating Senegal as the first Francophone African country to reach WHO Maturity Level 3, enhancing patient understanding and ethical standards.
Capacity-building training sessions conducted across four clinical research sites, focusing on equipping staff with essential skills.
A reflection on the growth, challenges, and achievements of Pharmalys over the past year, highlighting the role of community health workers, multicultural environment, and team support.
Insights from Arthur Makadi on his role, the company's mission, technological innovations, and his personal commitment to advancing global health through research.