![]() Over the last 15 years, sponsors have increasingly turned to the emerging markets in Brazil, Russia, India and China (BRIC) to fulfi l patient recruitment accrual ahead of time and, more recently, significant growth in clinical trial activity has also been seen in CEE (3). They also often lack a contingency budget if problems occur in the trial, placing more pressure on sponsors to get the site distribution strategy right first time. Virtual biotech companies often have few employees with hands-on clinical research experience in a particular locality, and without global affiliate offices biotech companies often have to rely on their chosen partners in assessing the benefits and risks of each country. The question as to which countries to involve for the best return on clinical trial investment is difficult to answer. More often than not the reason for requiring additional countries is to meet patient recruitment goals for larger clinical trials or challenging populations, or to ensure that partnering or out-licensing is initiated when required in the business pipeline. This article reviews some of the practical steps available to ensure an effective and successful clinical trial, defined as meeting trial timelines, quality metrics and budget.ĭuring the development lifecycle of any product, a critical decision concerns the sponsor’s need to involve additional countries to meet their clinical development goals. However, given the fact that many of these biotech companies can be ‘virtual’ in nature, geographically removed from the region and may have relatively little or no experience of running trials within these regions, there may be a number of pitfalls to avoid during clinical trial execution. This finding, coupled with the rising cost of drug development, has led many biotech companies to look towards central and eastern Europe (CEE), Russia and Ukraine as a solution to their clinical trial needs and the increased competition for investigational sites in the established European Union (EU) member states. Recent pharmaceutical and biotechnology industry reports indicate that R&D spending in Canada, Europe, Australia and the US increased by two per cent to $22.8bn, after tumbling by 21 per cent during the downturn in 2009 (1,2). Ockham's James Baker, who will become Chiltern’s Chief Development Officer, said joining with Chiltern was "an easy choice," which will allow the group to leverage its "global reach and highly developed staffing business in Europe, both of which are complementary to Ockham’s deep oncology expertise and source business in the US".As more biotechnology companies look to CEE for clinical trials, Natalie G Harris and Anthony Southers of Ockham explore risk-mitigation strategies and the benefits of local knowledge ![]() The combined company will be called Chiltern, and Ockham’s management team will filter into the merged group, to help ensure "seamless continuation of high quality services".Įxplaining his firm's interest in the marriage, Chiltern Chief Executive Officer James Esinhart said the move "is a natural progression towards our strategic goal of becoming the premier specialised mid-tier CRO". UK-headquartered contract research organisation Chiltern has snapped up US group Ockham to cement its standing in oncology, source and biopharmaceutics development.Ĭhiltern said it has acquired 100% of the Cary, North-Carolina-based firm, significantly strengthening their combined service offerings across these three strategic areas.
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