The Division of AIDS (DAIDS)’s Office of Clinical Site Oversight (OCSO) visited the Botswana Harvard Health Partnership (BHP) on the 15th to 16th August 2023. The two-day visit was meant for the OCSO to appreciate the Clinical Trials Unit (CTU) processes and tour the facilities. The DAIDS four-person entourage included OCSO Director, Manizhe Payton, OCSO Programme Officer Representative, Teri Greenfield, OSC Pharmacist, Thucuma Sise and OCSO Pharmacist Brach Chief, Ruth Ebiasah.
BHP presented an overview of the institution and the CTU structure as well as the protocols conducted by the CTU. They also presented the challenges the sites are experiencing such as more frequent study monitoring visits which despite being necessary, take away the time for conduct of the study. BHP appealed for a well-structured way of scheduling study monitoring visits that will not negatively impact of the time needed for study conduct.
“We come as a partner, this is not a monitoring visit, this is a visit from your partners to appreciate the operations and the processes of the sites and the work that is being done at the sites. We have also come to appreciate each and everyone from BHP for the great work that you have done with the EMA inspection,” said Manizhe Payton, alluding to the recent successful European Medicines Agency (EMA) that was conducted for the HPTN 084 Study.
“I convey a congratulatory message from the Director of DAIDS and your Programme Officer for a job well done with the successful EMA inspection. It is a great deal of hardwork that you have done considering that did not have any prior experience with an EMA inspection,” said Payton.
Payton noted that they also wanted to appreciate how the sites are implementing the changes necessitated by the EMA pre-inspection preparation activities. The delegation visited the BHP Clinical Trials Unit’s Gaborone and Molepolole Clinical Research Sites, the laboratory and the Gaborone site pharmacy. The team expressed happiness over the robust processes that the BHP employs in the conduct of its studies. They praised BHP researchers for being able to work across multiple networks as well as being able to harmonize the best practices from one protocol to complement other networks’ protocols. They praised the CTU leadership for great leadership for the good work which is demonstrated by the excellent processes and the quality of work at the CTU.