Quality in action: How Pharmalys drives excellence beyond the everyday
At Pharmalys, Quality is more than just a word – it is our promise.
Quality can be defined as the standard of something as measured against other things of a similar kind, or the degree of excellence achieved. In clinical research, Quality ensures that clinical trials are conducted in full compliance with regulations, that data is robust and reliable, and that patients are protected and their rights respected.
At Pharmalys, we adopt a true culture of Quality. It is a collective commitment shared across the organisation. Our Quality team is always accessible when questions arise, providing clarity on SOPs, supporting issue resolution, delivering training on new procedures, regulations and guidance, and conducting audits to continuously strengthen the quality processes of Pharmalys, our providers and our clients.
Contributing to the wider quality community
The Director of the Pharmalys Quality Management department is highly committed to his profession. Alongside his core responsibilities, he is an active member of the BPC News group.
Created approximately 25 years ago, BPC News brings together around 100 professionals in Quality Assurance, Regulatory Affairs and Clinical Operations from both public and private organisations. The group meets roughly every six weeks to exchange insights and share experiences on current topics of interest, such as ICH E6(R3) and its impact on investigator sites and Data Governance, lessons learned from inspections, personal data protection, and system audits.
Read more about Pharmalys quality culture.
Delivering excellence under complexity: Lessons learnt from Africa
Pharmalys is an international Clinical Research Organisation (CRO) with a diverse team distributed across Europe, Asia, North America and Africa. Within our global portfolio, we support the execution of numerous clinical trials (CTs) in Africa. Across these projects, the experience, flexibility and responsiveness of our staff – from Project Managers (PMs) and Clinical Trial Managers (CTMs) to Clinical Research Associates (CRAs) and Clinical Research Assistants (CTAs) – are essential to consistently meeting clients’ expectations and requirements.
Executing clinical trials anywhere demands rigour, but doing so in Africa requires an additional level of operational resilience and adaptability. From navigating complex regulatory landscapes to ensuring CTs begin without avoidable delays or costly missteps, our focus is operational excellence: enabling trials to run smoothly, efficiently, and transparently. Our teams are trained to respond effectively to unexpected challenges, allowing us to consistently meet sponsors’ expectations and study timelines.
Several Pharmalys team members operate both in the Global North and Africa, and their comparative experience highlights an important reality: working as a clinical research professional in Africa requires a broader skill set and a remarkable ability to adapt to constantly evolving operational environments. This context creates a unique setting which technical expertise must be complemented by exceptional agility.
Regulatory and Ethics Approvals
Obtaining clinical trial approval from Regulatory Bodies (RBs), Research Ethics Committees (RECs) and Institutional Review Boards (IRBs) represents a major milestone in CT implementation. In contrast to the Global North – where regulatory pathways and ethics submissions are typically standardised, and timelines are often benchmarked to predictable service levels – submission processes in Africa can vary significantly by country and over time.
Regulatory Affairs and Study Start-Up by Pharmalys
Your trusted partner for regulatory success across Africa and beyond
Our Regulatory Affairs and Study Start-Up Unit (RAS Unit) navigates complex regulatory landscapes with expertise and care, helping you launch your clinical trials without avoidable delays or costly missteps, ensuring they run with clarity, compliance, and confidence.
From early feasibility to study close-out, we ensure seamless alignment between sponsor timelines and local regulatory requirements. We anticipate roadblocks, simplify processes, and connect stakeholders, turning regulatory challenges into structured pathways to approval.
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