PRA International has called on Netherlands-based software group Quintiq to help manage the Ph I research projects it takes on and better allocate resources in the challenging early-phase trial sector.
Medidata says the latest addition to its EDC platform, the Rave Safety Gateway, will cut the time it takes to report adverse events during trials and help CROs and their sponsors comply with increasingly stringent reporting rules.
A MEP has questioned the EC’s estimate that 20,000 API producers supply the EU, which was used to justify not having mandatory inspections, and the CEO of Hovione added that the numbers have been “dramatically misunderstood”.
Globalisation and “heightened awareness and scrutiny of clinical trials” in the wake of the Northwick Park, UK incident, where some patients suffered multiple organ failure, have had a significant impact on study insurance, according to a MD.
Comparative effectiveness research (CER) represents a “historical market opportunity”, according to a VP at Quintiles who explained that pharmas that do the work will be “properly rewarded for their innovations”.
Quintiles and Cerner are combining their “unique sets of experience and expertise” to improve the efficiency of late phase research, the market for which exceeds $1bn (€677m), according to a SVP at the CRO.
The GAO sting operation and subsequent increased scrutiny will “definitely change how pharma and CROs choose IRBs”, according to the VP of NEIRB who spoke to Outsourcing-Pharma after successfully completing a FDA audit.
The FDA is hoping to increase the likelihood of a clinical trial being successful by making best use of science and alternative study designs and has issued end-of-Phase IIa (EOP2A) meeting guidance to explain the process.
Quintiles has targeted Africa as the next non-traditional area to develop new medicines and the opening of its office in Ghana, which is now fully operational, is a major step in this process, Gillian Corken, head of Quintiles in Africa, told Outsourcing-Pharma.
Recruiting patients with rare diseases for clinical trials could become easier if the US Congress passes a bill to allow patients on supplemental security income (SSI) benefits to receive compensation.
Outsourcing to a well known CRO with a good reputation is vital to ensuring that data is well received by regulatory authorities, according to a CEO that just inked a deal for preclinical safety testing.
A significant number of articles in six of the top 10 medical journals in 2008 were ghostwritten, according to study by editors of JAMA that found responding authors reported a 10.9 per cent rate in the NEJM.
Following a review of the backlog of postmarketing studies the FDA has initiated changes to improve its processes, including developing Manuals of Policies and Procedures (MAPP) to track the status of trials.
US drug giant Pfizer has joined the growing list of organisations seeking to boost trial recruitment via the web, teaming up with IT firm Private Access to create a website designed to “increase clinical trial awareness and participation.”
Clinical trials in the developing world meet the same standards as those in Europe and the US and are vital for accelerating drug development says the Association of Clinical Research Organisations (ACRO).