Myth Busting Clinical Trials in Africa

Myth Busting Clinical Trials in Africa

Africa poses unique challenges, therefore, we have created unique solutions to “De-Risk Pharma Companies” and provide “End to End Solutions” for the conduction of “Seamless Clinical Trials in Africa”.

Background

  • Opportunity begging to be realised.
  • MERCLINCO identified a gap in clinical trials globally.
  • African diversity offers answers to the challenges which cannot be found in the rest of the world.
  • 7.5% of the global population, 2.5% of clinical trials, 24% of global disease burden – increasing Non Communicable Disease Profile, including Oncology.
  • Genetic diversity – differing responses to treatment in different nations.
  • Cannot extrapolate clinical trial results from Seattle to Senegal.
  • Oncology is a bigger killer than Malaria in Africa.
  • Clinical Trial Naïve sites and patients.

MERCLINCO’s investment in Africa over the last 5 years:

Goals

  • Create a fully operational Ecosystem that is credible, reliable and sustainable.
  • “De-risking” clinical trials in Africa for Pharma Companies.
  • Digitising clinical trials.

Methodology

  • Detailed understanding of the unique challenges of conducting clinical trials in Africa.
  • Developing innovative and sustainable solutions.
  • Rigorous testing of the proposed solutions.
  • Refining Solutions.
  • Implementing Proactive Solutions.
  • Training Programs.

Solutions – Multi-layered

  • Infrastructure development.
  • Strategy development to minimize risk to Clients conducting Clinical Trials in Africa through multiple interventions.
  • Capacity building.
  • Site Development Programs – high quality training programs (Investigators, Study Coordinators, Data Coordinators, Pharmacists, Recruitment Officers, +++).
  • Strengthening and Standardising Regulatory Processes by working hand-in-hand with Regulatory Authorities in each country in Africa.
  • Supply Chain Management.

Outcomes

  • MERCLINCO learned how to conduct clinical trials differently in Africa to achieve superior outcomes.
  • Network of High Quality Sites; meeting stringent criteria for accreditation.
  • Innovative Recruitment Solutions – SCRS SPRIA Awards – 2015 & 2019 Winners.
  • MERCLINCO provides access to Clinical Trials to the entire spectrum of demographic diversity.
  • Improved Timelines for regulatory approvals of protocols.
  • Centralised Hub – feasibility, contracts and budgets, regulatory, quality, recruitment, ++++ – warp speed turn-around times = accelerated study start up and completion.
  • Formed Strategic Partnerships:
  1. Shipment of biological samples (Africa and global).
  2. Supply chain management (Transport of equipment, supplies, Investigational Product).
  3. Bonded warehouse.
  4. Importer of record.

All building the blocks are now in place – we have capacity and ability to deliver on your needs.