Clinical Programs Group

54gene’s Clinical Programs Group utilizes our scientific, regulatory and operational expertise to provide innovative, customizable, and cost-effective clinical trial solutions in Africa.

We collaborate with local and global partners to design and conduct clinical studies that demonstrate the safety and efficacy of their medical products.

Our experienced native experts, robust sites network, and established infrastructure in the region are leveraged to generate clinical or real world evidence data to drive positive research outcomes.

Our Clinical Programs Group (CPG)

Clinical Trial Management

Every study is unique. We offer our partners a flexible tailored approach to achieving their specific study needs. The entire study or a portion can be outsourced to us based on the customer’s preference.

Regulatory Affairs

Regulatory submissions customized to specific regional requirements may seem weighty. 54gene offers regulatory strategies and operational support that facilitate and speed up clinical validation and market access for new medical products in the region.

Project Management

Quality, speed, and cost-effectiveness are built into our project management processes and tools. From conceptualization through execution, we work on planning, coordinating and executing projects based on your specific budgets and constraints.

Sample & Supply Management

For all clinical trial phases, our highly trained teams have the experience and skills to implement your study supplies and sample management specifications.

Laboratory Testing

Our laboratories are equipped with worldclass equipment and provide analytical testing in multiple disease areas to meet clinical studies sample testing needs.

Pharmacovigilance

Collection, monitoring, and reporting of product safety information are critical to patients wellbeing, success of clinical studies and for maintaining products post-approval licenses.

Partners

Global Clinical Research Organisations (CRO)

To global CROs, we serve as an extension of your core teams and your boots-on-ground resource for conducting studies in multiple regions in AfricaThrough us, our CRO partners gain easy access to untapped geographical areas to generate a more diverse set of clinical data.

Biopharmaceuticals

Our partnerships with pharmaceutical, biotechnology and medical device companies span all phases of clinical trial services from early to late-stage studies. We support the design, planning, execution, and reporting of your studies.

Academia and Foundations

We have long-standing partnerships with notable international universities and medical trusts to advance medicine through the co-development of new products and optimisation of existing therapies.

Our partnership with international healthcare organizations has pushed us to take giant strides in strengthening our clinical research and development activities targeting diseases that are endemic to geographical areas in developing countries.