Study Design
Based on the research and medical expertise within Virtus, we provide advisory services in designing practical, effective and cost-efficient study protocols, along with CRF's and related documentation.

Working with clients we ensure that protocols meet stringent clinical, statistical, and logistical standards, as well as international guidelines for Good Clinical Practice. Particular emphasis is placed on appropriate outcome measures and practical inclusion / exclusion criteria to facilitate recruitment of the appropriate patient populations.

Regulatory Processes
The South African Regulatory Authorities viz: Medicines Control Council (MCC) and the various ethics review boards operate according to international standards and under efficient and time-sensitive review processes. Generally the review process is completed within 12 weeks of submission to the regulatory authority.

The MCC has a well defined application process, which needs to be supported by the appropriate documentation such as protocol, IDB etc. Once the documents are submitted, MCC responds within a few weeks, requesting clarification and perhaps additional data. Thereafter the Clinical Trials Committee reviews the documentation and approves the application.

In parallel, Ethics Committee applications are prepared and submitted. These approvals are required by MCC prior to commencing a study. The speed at which the various Ethics Committees approve varies. Pharma Ethics which deals with private institutions approves within 4 weeks. Stellenbosch University, which is a State Institution, can take up to 8 weeks.

However, by doing things in parallel with the MCC application procedure, Virtus has in the past ensured that approvals from both bodies are organized to arrive almost simultaneously.

We have enjoyed a 100% success record with our submissions to MCC and the various Ethics Committees. We have met all deadlines. This has been achieved with the co-operation of the sponsors and the expertise we have in preparing and handling the submission of documentation. To ensure arrival by deadlines we deliver applications to MCC personally and obtain record of receipt. We then follow up with contacts and answering any queries within the specified deadlines.

Additionally, via our associates, we have excellent connections to MCC and the Ethics Committees. We select investigators whose reputation for outstanding work is recognized by MCC and Ethics Committees.

Our medical and regulatory experts will advise, and organize submissions and communications with the MCC and the various Ethics Review Committees in South Africa.

This service will include:

• Advice on regulatory considerations and amendments in respect of drug development planning
• Advice in respect of meeting any unique and specific requirements of the MCC and the Ethics Review Committees
• Submission and approvals of clinical trial applications and updates throughout the development phases
• Adverse event reporting