UK-based contract research organisation (CRO) QED Clinical Services has launched a specialist division to address the increasing demand for, and particular challenges of, drug development for rare diseases.

The new division, OrphanReach, will capitalise on QED’s global infrastructure while offering a flexible, adaptive drug-development model that draws on research professionals with experience in rare-indication trials and a strong project management team who “understand the importance of critical milestones being met on time and on budget”, the CRO says.

One of the most taxing challenges in developing rare-disease treatments is recruiting sufficient numbers of patients from a sparse and often widely distributed population, QED points out.  The CRO’s global reach gives it access to patients in more than 50 countries across five continents.

Local infrastructure

Wherever orphan-drug trials are conducted, it is of paramount importance to have a local development infrastructure in place that supports the specific needs of rare-disease studies, QED adds.

Close communication with investigators to keep trial sites engaged, along with site management by experienced senior clinical research associates, “are two important elements to ensure that patient recruitment timelines and quality standards are met”, it notes.

“Any company developing drugs for orphan indications needs a service provider who can not only offer tailor-made solutions in a very effective and attentive way, but also has access to these rare patient populations no matter where in the world,” commented Thomas Ogorka, chief executive officer of QED Clinical Services.