Contract research organisations (CROs) provide clinical trial and other research support services for the pharmaceutical, biotechnology and medical device industries as well as government institutions, foundations and unversities. The International Conference on Harmonisation (ICH) defines a CRO as ”A person or an organisation (commercial, academic or other) contracted by the sponsor to perform one or more of a sponsor’s trial related duties and functions.”Although a trial sponsor may transfer all trial functions to a third-party CRO, the sponsor remains responsible for the integrity of the trial data.

Types of Services provided:

• Project management

• Database design & build

• Data entry & validation

• Clinical trial data management

• Dispensing Services

• Quality and metric reporting

• Statistical analysis plans and reports

• Validation programming

• Safety and efficacy summaries

• Final study report

For an industry that barely existed a decade ago, the CRO sector is performing very well compared to other industries. Analysts suggest the industry is growing from 4 percent (%) to 12 percent (%) annually.

In 2012, the largest CROs were Quintiles, Parexel, Covance, Pharmaceutical Product Development, Icon, INC Research and inVentiv Health Clinical, according to Industry Standard Research. The top 10 CROs control over 50 percent (%) of the market.

Who is the CRO Sector Audience?

People interested in the CRO sector;

• Project Managers

• Investigators

• Regulatory Staff

• Clinical Staff (Nurses, Clinical Technologists and Pharmacists)

• External Monitors/External Clinical Research Associates

• Post Clinical Services (Bio-statistics, Data Management and Medical Writing).

What are the Projects to be focused on for the period 2015 – 2016?

• Actively working towards shorterning of Timelines for Approval of Bio-equivalence Studies at MCC to 4 weeks by establishing communication and follow-up strategies to ensure optimal collaboration in this regard.

• Clinical Trials in Paediatrics – Summary of Guidelines.

• Increasing the numbers of people attending the annual SACRA Meetings in Bloemfontein by extensive and pro-active advertisement and knowledgeable speakers and “hot” topics to be presented.

• To maintain and grow the current membership and the quarterly meeting attendancein Cape Town. Currently we have an attendance of 30 - 40 members per meeting. To encourage active member participation through projects such as the book donation drive and to host workshops such as the Dilicom Informed Consent workshop. To also prepare for succession planning by growing CT involvement in meeting preparations.