Australian contract research organisation CPR Pharma Services is launching a new programme aimed at US-based companies looking for an easier way to run early-phase clinical trials in Asia.
Access2Asia, which CPR will officially unveil at the Partnerships in Clinical Trials conference in Orlando, Florida next week, is targeted in particular at small to medium-sized pharmaceutical and biotechnology companies in the US that want to extend their reach into Asia but may be nervous about quality issues or project delays in the face of complex local regulatory requirements.
CPR is offering to ease the transition by plugging US companies into its network of Phase I trial units, as well as managing and monitoring Phase IIa and IIb studies through a chain of hospital sites across Asia, dealing with local regulatory authorities through local agents, and backing all this up with expertise in project management, monitoring, data management, quality assurance, pharmacokinetics, bio-statistics, bioanalytics and report-writing.
Regional leader
Following last year’s opening of its Singapore office and the launch last month of its Large Molecule Immunochemistry Analytical Service for Asia-Pacific trials, CPR now claims to be a regional leader in the provision of clinical-trial services, “albeit with a core focus in Phase 1 and bridging studies”.
CPR says the clinical trial market in Asia is growing at a rate of 20% per year.
According to Jason Valentine, chief executive officer of CPR Pharma Services, Access2Asia can give US companies an intro not just to “Western-style high-quality clinical trials at a fraction of what it costs in the US or Europe” but to the booming Asian market overall.
“Asia, and particularly China, has a growing middle class that wants access to pharmaceuticals, he noted. “ In order to access this market Western companies need to trial their drugs in the region.”
Approval times
Valentine said gaining approval for a typical Phase 1 trial in China might take up to 20 months.
Using Access2Asia, though, a trial could start in Australia within as little as three to six weeks, then incorporating an ethnicity arm would enable the regulatory process in China to get underway much sooner, “potentially taking two years off of the current timeline for access to the Chinese market”, he added.
“CPR Pharma Services is the only CRO in the region that can offer a quick turnaround in early-phase trials in Asia, as well as the opportunity for US companies to have an on-the-ground expert managing all aspects of the trials,” Valentine commented.
