Our Services

We suppy the following services to the pharmaceutical industry:

Complete clinical trial monitoring and site management

  • Phase I
  • Phase II
  • Phase III
  • Phase IV

These occur in various therapeutic areas countrywide (South Africa) as well as within Africa.

Our staff has experience in Studies ranging from small phase I studies of 28 patients, to large multi-site 3000+ patients, phase III studies.

Regulatory affairs

  • Compilation of all necessary documents for MCC Submission (Medicine Control Council - regulatory body of South Africa) and Ethics Committee submission.
  • All SAE reporting for all studies.
  • Investigator assistance for Ethics submissions and subsequent correspondence.
  • Arrangements of laboratory sample export permits with the Department of Health. These are usually obtained within 7 working days.

Regulatory affairs continued

  • Obtaining Import Licenses for Veterinary products, if needed
  • Completion of Annual and bi-annual updates to the regulatory and EC’s.
  • Any other regulatory services and communication regarding a trial.

Importer/ Exporter for clinical trial Drug supplies

  • The storage of drugs is outsourced to a preferred provider (Pharma-Logistics Services) a registered Clinical Trial Supply facility within South Africa.  ClinResearch is a registered importer of Clinical Trial Supplies.
  • Cold chain shipments are possible and sent from the depot directly to site on behalf of the sponsor.
  • Bulk shipments are received at the depot.

Site identification and selection

  • Selection of investigational sites for optimal recruitment.
  • Negotiation of grants and payments.
  • Set-up and identification of laboratory agreements per study.
  • Negotiation of contracts with the pharmacy and pharmacists
  • Negotiation of agreements with the hospital or clinics where the trial will commence.

Protocol and CRF development

  • This is outsourced as required by sponsors and reviewed by the team.
  • Arrangements for printing of CRF’s can be done by a local company.

Sourcing of supplies, equipment and comparator drugs for the Clinical Trials on behalf of the sponsor

  • Should the need arise, comparator drug or rescue drugs will be sourced and distributed to the sites.
  • Other supplies i.e. centrifuges, lab supplies, refrigerators and other supplies to set up a site can be sourced by ClinResearch per study requirements and should the need arise.

Patient Information Leaflet and Informed Consent Document Compilation, and translation using registered translation services

  • Arrangements for the translation of informed consents according to the specified languages are made with a registered translation group as well as the formatting and setting up of the informed consents per regulations of the Ethics Committees within the country. 
  • Translations of documents are arranged for African languages, as required by the specific country.

“Monitor” for hire facility

  • Monitors are outsourced to a CRO or pharma group for a short term period in the case of an associate being on pregnancy leave or sabbatical

Other Monitoring Services

Monitoring Services are also provided without project management where the sponsor prefers to keep the project management in-house.