CRIntegrations

Who we are here at CR Integrations

As an organization focusing on Clinical Trial Services in South Africa and the South African Development Community (SADC region – Angola, Botswana, Comoros, Democratic Republic of Congo, Eswatini, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, Swaziland, United Republic of Tanzania, Zambia and Zimbabwe) we can assist your team in finding solutions to challenges and various tailor-made required services.  We are passionate about our database of excellent reputable trial centers that we have worked with over a period of 25 years as well as our knowledgeable CRA’s, CTA’s and Vendors.  We have a diverse range of clients including medical device, diagnostics, biotechnology, and pharmaceutical companies.

 Our Clinical Research Associates will co-ordinate clinical study sites ready to recruit, wherever they are based. We work according to the approved plan to monitor the study, manage challenges, and solve problems to keep you on track and within budget.

WhAT WE Offer

We can support your trial using appropriate technology to support decentralized elements of the trial delivery. We then build the right team around your trial needs.

  1. Critical review of existing trial design
  2. Oversight Monitoring on existing Trials
  3. Clinical Evaluation Report Writing
  4. Clinical Investigation Plan/Protocol writing
  5. All study document creation in compliance with applicable regulations
  6. General regulatory affairs expertise
  7. Clinical trial applications to competent authority
  8. Ethics board submissions
  9. Site budgets and contracts
  10. Site selection and set up
  11. Vendor management
  12. Site management
  13. Safety reporting and management
  14. Remote and on-site monitoring
  15. Feasibilities, Site Selection, Site Evaluation, Site Initiation, Site Monitoring and Site closure