CaTNuS - Clinical Trials in a NutShell

This program is accredited by SAMA and the Faculty of Pharmaceutical Medicine of the United Kingdom – attendees will receive 16 CPD points at the completion of the course.

  • The goal is to train staff in the public sector on Clinical Trials – we provide this training for free to the Public Sector.

  • Intended to grow and transform the public sector with the opportunity to open trial sites in their facilities.

  • To empower staff to be able to work in the trial industry; further as an SMO (MeDiNova MERC SA) we require of our Affiliate Sites to open their sites to trainees and take part in our incubation program; offering an opportunity to the trainees to gain practical experience in the industry.

SAHPRA is needed as a Private entity to assist in developing relationships with the Public Sector in the country – we want to roll out this course right across the country and empower more and more of our colleagues in the public sector.

Is there a way that SAHPRA can assist us in developing relationships with the Public Sector? How do we open these doors?

It is proposed that SAHPRA should have an action plan on how they plan to develop the relationships between, Private, Public and Pharma companies.As part of this document SAHPRA must have a plan to direct Pharma companies to assist in sponsoring educational programs, sponsoring of equipment to the Public Sector sites, etc.

It is clear that Private sector Sites really do struggle to take part in proper capacity building exercises – as they do not have the financial means and capacity to appoint and train staff; as MeDiNova MERC SA we try to assist the sites achieve this; by providing the sites with the opportunity to be an incubator for new staff – I think SAHPRA/Pharma companies should assist in the funding of these projects if at all possible.

The other issue that we also identified as an obstacle for new Investigators to enter the Industry; is the requirements to be approved as a PI on a study- the barriers of entry are extremely high and almost impossible for new Investigators and sites to take part in trials – how will SAHPRA assist these new Investigators and sites? I think our Incubator Program can be of help here…

MeDiNova MERC SA & SACRA can play a huge part in the Capacity Building and Transformation of our Industry; if only we are allowed and assisted to provide this service to all the stakeholders.

CaTNus Programme Status:

  1. Currently running successfully at Middelburg Government Hospital, Mpumalanga;

  2. In discussions with Medunsa Department of Pharmacology to roll out this programme to their graduate students;

  3. Awaiting confirmation from Worcester Hospital for presenting the programme there;

  4. Resistance still experienced from some of our colleagues (Medical Managers &/ CEO’s) in the state sector – lack of knowledge about our industry and apathy are the key challenges that we continuously face;

  5. Government needs to come to the party in order to make Capacity Building & Transformation Agenda (CBTA) work;

  6. Government Departments that we need to see at the Table: CTC, DoH, DoS&T, DTI, DoHE, Dept. of Small Business Development, Deans of Medical Schools & University HoD’s form Departments of Pharmacology;

  7. “A dedicated Capacity Building and Transformation Committee representing all stakeholders in clinical research should be created”