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Clinical Trial Site Support

Clinical Trial Management

Clinical Research Services

University of Witwatersrand, Johannesburg (South Africa)

Clinical Trial Site Support
WHC is focusing on developing its existing clinical trial sites as well as expanding the number of sites on its books. WHC is fortunate to operate within the academic sector which provides access to a rich source of new investigators, as well as an extensive pool of suitable trial patients. During 2004 WHC initiated a new strategy whereby it partners with investigators in the establishment of focused and well resourced clinical trial sites, with the objective of securing additional well recruited studies. This enables the site to generate the funds required to stimulate original research activities, whilst simultaneously enabling clinicians to provide the much needed latest medical treatments to public sector patients.

Site Evaluation
Sites are audited by WHC against Good Clinical Practice standards in order to identify the weaknesses requiring correction. WHC also assists with the site rectification process.

Standard Operating Procedures (SOP’s)
An important component of any well managed site is SOP’s and WHC provides its sites with generic and customised documentation.

Site Personnel
WHC provides sites with the personnel required to undertake studies and enable the expansion of the clinical research activities. WHC provides sites with Clinical Research Managers, Medical Officers and Study Coordinators, which has impacted positively on new site initiation and the quality of existing business.

Marketing support
WHC regularly meets with the pharmaceutical industry and other research sponsors to present the sites falling under its umbrella.

Clinical Trial Management
As WHC provides the legal umbrella under which studies are conducted it is closely involved in the oversight thereof to ensure that such are managed in a proper, ethical manner and in accordance with sponsor requirements. WHC therefore provides a suite of services to support the studies.

Investigator / Site Recruitment
When approached by sponsors WHC sources suitable sites and investigators for these potential studies.

Project Management
The WHC Clinical Research Managers are closely involved with the sites in ensuring that studies are properly conducted. In addition to study oversight, WHC provides sites with recruitment tools, documentation filing methodologies, patient visit scheduling and payment management spreadsheets to facilitate efficient study management.

Financial Contract Management
Being the legal entity under which studies are conducted, WHC is the institutional signatory on all financial and service contracts, and as such reviews or drafts such as required.

Billing and Debtors Management
WHC raises invoices for completed patient visits upon receipt of sponsor monitored schedules, and the subsequent payment monitored and recorded when received.

Clinical Research Services
Through the expansion of its Site and Project management activities, WHC has been able to broaden the services it is able to offer the wider clinical trials industry, and in particular to the academic sector. The services provided include:

Training
The following training courses are provided to the academic and private sectors involved in clinical trials:

  • Good Clinical Practice (GCP) Training 

Monitoring
WHC provides independent monitoring, quality assurance and drug accountability management for studies. The WHC team is ideally placed to supplement the partial monitoring activities conducted for international, multi-centre grant sponsored clinical trials.

Regulatory submission services
The team provides MCC and Ethics Committee regulatory submission services for academic and private clients.


Chief Operations Officer
Dr. Maureen Joffe
Tel (011) 339 0610
Fax (011) 339 0638
Cell 082 924 0000
Email: mjoffe@witshealth.co.za

Street Address
Wits Donald Gordon Clinical Trial Site
18 Eton Road
Parktown
2193

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