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OnQ Consulting - a South African Contract Research Organization

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OnQ Consulting - a South African Contract Research Organization

OnQ Consulting is a South African based Contract Research Organization. OnQ has been in existence since 1999, and is able to assist both local and international clients right from program and protocol concept right through to the study execution and report generation. We pride ourselves on our in-house expertise. We have experts on hand who advise on protocol content, both within the context of conducting the trial within South African conditions, as well as ensuring the trial stands up to international scrutiny and ultimate filing for registration. OnQ is rich in terms of project management, and monitoring abilities. Our clinical team has extensive experience in many therapeutic areas of expertise. The team appointed to each study is chosen dependent on both therapeutic and years as experience, as well as geographic location. Having offices in both Johannesburg and Cape Town affords the senior management the convenience to manage and oversee regional project teams with ease. We have senior staff well versed in the ability to manage and coordinate clinical trials throughout Southern and Eastern Africa. OnQ has site and regulatory expertise within the following African countries: Zimbabwe, Botswana, Mozambique, Uganda, Kenya, Tanzania, Burkina Faso, Zambia. The clients of OnQ typically comprise of multinational pharmaceutical companies, as well as biotechnology companies, and local academic research. The flexibility and cost structure of OnQ lends itself to be both a supportive local resource, as well as able to implement and conduct an entire clinical trial for sponsors outside of South Africa. OnQ has expanded into the arena of training and is able to offer an accredited study coordinator training course, as well as a formal CRA training course offering both field and classroom training from 2007. OnQ is proactive in terms of quality assurance, and conducts in-house audits, as well as able to sub-contractaudit capabilities. In 2004 OnQ Consulting expanded to provide the services of a fully functional data-management company, thereby founding OnQ data. Performing data-management services both as a natural follow on to the project management, and monitoring offered by OnQ Consulting, or as a stand-alone service. OnQ data is an efficient and affordable data management service performed in accordance with the highest quality standards namely ICH Guidelines and FDA Regulations. Utilising a validated clinical data management system combining state-of-the-art technology with our professional expertise. OnQ data is headed up by one of our company owners who is hands on in the management of all projects, ensuring quality is distributed throughout the project by the entire team. utilising a server-based data management system, namely Clindex. Why South Africa? South Africa is an exciting country within which to conduct clinical trials. South Africa has a well-established infrastructure allowing advanced technology and expertise within world-class hospital facilities. South Africa has academic hospital facilities, affiliated to regional universities. Many of these sites have world-renowned academic expertise. The academic hospital environment is supported by an extensive private hospital network, with advanced technology, equipment and expertise. South Africa has an established regulatory and ethical authority environment. The diversity of the population ensures that many patients are available for possible selection into a clinical trial, with many patients being treatment naïve. Participating in a clinical trial is a unique and beneficial process for many patients. Rapid and quality recruitment is thus an advantage for conducting a clinical trial in South Africa. The majority of sites have the infrastructure to support a clinical trial, both in terms of technology, and advanced communication systems as well as site staff at many sites having well in excess of twenty years of clinical trial experience. The majority of clinical sites are supported by study coordinators, and OnQ itself has a pool of dedicated study coordinators. The capacity and scope for conducting clinical research within South Africa has not yet been fully realised, and thus the opportunity to conduct a clinical trial within South Africa is met with enthusiasm, energy and creativity to ensure that the demands, and expectations of the client are at least met, if not exceeded. Site capacity building is an ongoing focus of research organizations within South Africa, to ensure that diverse sites are continually being trained up and added to the already significant, and competent pool of trained investigators. South Africa’s regulatory and ethical authorities requires that investigators be formally trained in ICH / GCP principles prior to being approved as an investigator in a study. This training is certificated, and is only valid for three years. Although South Africa has eleven official languages, English is the business language and is widely spoken. Exchange rate benefits against the major currencies ensure that conducting clinical research in South Africa is cost-effective.

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