Currently there are few contract research organisations (CROs) with offices in the UAE but Faiz Kermani, author of A quick guide to healthcare and biotechnology in the Middle East, believes this will change in coming years.
Speaking to Outsourcing-Pharma, Kermani predicted that the UAE’s incentives to attract pharmas to the region, which have seen Pfizer, Amgen and AstraZeneca establish offices, will result in CROs following them.
In particular Kermani believes CROs will be attracted to Dubai. Kermani explained that the emirate has used “massive amounts of money and huge incentives” to attract pharmas to its DuBiotech and Dubai Healthcare City developments and predicted that CROs will follow.
Some CROs have already established offices in these developments. Ergomed became the first CRO to have an office in DuBiotech in October 2007 and in May the following year ClinTec moved into Dubai Healthcare City.
ClinTec’s decision to set up in Dubai was partly because of the presence of top 10 pharma companies, according to Rani Abraham, the CROs regional manager for the Middle East & North Africa.
Abraham explained to Outsourcing-Pharma that the UAE has “opened up immensely for research” and that this, coupled to the concentration of big pharmas in the region, could lead to it becoming a hub for clinical trials.
In addition Abraham believes that operating in the UAE could quicken regulatory approval for a drug because it allows data to be generated from a different ethnic population.
Operating in the UAE
Studies conducted in the UAE comply with International Council on Harmonisation good clinical practice (ICH GCP) guidelines, according to Abraham, meaning the data should be accepted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMEA).
In correspondence with Outsourcing-Pharma both regulatory bodies explained that the actual country where the study is carried out is not an issue, as long as the study is done appropriately.
There are currently 11 trials recruiting patients in the UAE, according to the World Health Organization’s (WHO) clinical trial database, and with this number predicted to increase ClinTec believes its services will be in demand.
From its base in Dubai the CRO offers project management, data management, training and regulatory affairs services. To execute these tasks the company employs local experts, a move which Abraham believes offers numerous advantages.
She explained that employing locals helps deliver faster services because they have a better understanding of regional regulations. In addition tasks such as translating informed consent forms require staff to know Arabic.