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LATEST NEWS
GSK disputes Argentine fine over baby vaccination scandal
12 January 2012
GlaxoSmithKline is set to appeal a ruling by the Supreme Court of Argentine on the fine it was issued regarding the administrative conduct of the COMPAS (Clinical Otitis Media and PneumoniA Study) study in Mendoza. GSK said it "respectfully disagrees" with the decision, which ruled in favour of ...
Industry balks at Indian ministry's call to 'pay clinical trial compensation or go'
16 December 2011
India's health ministry has notified new draft trial compensation rules that plan to 'restrict' sponsors, CROs or local representatives of foreign sponsors from conducting further clinical trials in the country if they fail to compensate participants for trial-related injuries or their heirs in ...
EU Pharmacovigilance legislation implementation likely to be staggered
07 December 2011
As the European Medicines Agency struggles to finance implementing the far reaching pharmacovigilance legislation, it looks as if the new requirements will be introduced in phases beyond the original July 2012 implementation deadline, confirmed Peter Arlett , head of pharmacovigilance and risk ...
'Stifling' EU Clinical Trial Directive should be reformed, say medical research bodies
27 September 2011
A group of high-profile European medical organisations and charities are calling on the European Union to reform clinical trial regulations, saying the current regulation is stifling medical advances across the continent. The statement to the European Commission and Members of the European ...
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FEATURES
The red, white, blue and grey of Russian trials
24 November 2011
The Russian law on circulation of medicines, which came into effect in September 2010, brought some clarification to the clinical trial approvals framework, but also a great deal of uncertainty and confusion. One year on, the situation has stabilised in a number of respects, but some grey areas ...
The European guide to paediatric assent
24 November 2011
Working across the many and varied countries within the EU can bring many barriers to success. Each country has its individual stipulations that, if not adhered to, can put a stopper in clinical trial progression. Dr Daniela Kösling and Dr Karen Menke of Premier Research take a closer look at how ...
Strategic implications of statistical analysis plans
22 November 2011
Statistical analysis plans for drug development clinical trials are often created without much thought to their strategic implications. Kathryn Wekselman identifies several key areas where strategic thinking in developing the statistical analysis plan can increase the likelihood of a successful ...
Strategically speaking: evolving trends in choice of Phase I populations
15 June 2011
Kendle 's head of operations for early stage research, Germaine Gross , discusses the evolving trends in Phase I populations. Evolution, the basic premise of survival, is pertinent to all walks of business, and yet, some sectors, such as the pharmaceutical industry have been slow to embrace new ...
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PEOPLE
Exco InTouch hires CTO
Exco InTouch , a provider of mobile patient engagement and communication solutions has hired Madhav Vattikuti as Chief Technology Officer (CTO). Vattikuti’s role will see him use his significant technology expertise and background to strengthen delivery and development of Exco InTouch’s market ...
Chiltern adds therapeutic experts to team
The CRO Chiltern International has hired Drs Marcelo Piccirillo and Carlo Lanza to its medical teams. Dr Piccirillo will serve as senior clinical research physician with special emphasis in developing the gastroenterology therapeutic area. He has 20 years experience in the medical and clinical ...
Henauer joins i3 as head of resourcing
PharmaNet/i3 , inVentiv Health’s clinical segment, has hired Dr Stephan Henauer as executive director, i3 Pharma Resourcing. In this role, Dr Henauer will provide leadership for PharmaNet/i3’s staffing business in central, eastern and northern Europe. Prior to joining PharmaNet/i3, Dr Henauer was ...
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COMMENTARY
Deals to drive innovation for the next three billion
Deals such as ICON’s recent acquisition of BeijingWits Medical Consulting not only reflect the opportunity presented by emerging growth markets but also the need for local knowledge to conduct business effectively and tailor new product development to local market needs. We expect more deals to ...
Prepare for the regulatory revolution
Every medicine has associated side effects, or adverse drug reactions (ADRs). The European Impact Assessment Report on Pharmacovigilance (PV) estimated that approximately 5% of all hospital admissions are due to ADRs and that ADRs are the fifth most common cause of hospital death, accounting for an ...
CROs: focus on therapeutic areas for project gains
Lifestyle, living standards and longevity will all play their part in the disease profile of the future global population. Aligned with these factors is the shifting market for pharmaceuticals, an increasing proportion of profits will come from outside of the US and Europe as the developing world ...
Navigating the sea of data protection law in European clinical research
In Europe, there is a common set of rules that regulate the collection, use, and sharing of personal data. These include strict protection of sensitive data such as health data. However, individual European countries have interpreted and implemented the rules on the use of health data in clinical ...
Lean strategies for R&D partnership transformation
Lean methods for transformation, believes Deloitte 's Julian Remnant , could form a foundation for multi-company collaborations that might define the next generation of industry partnerships. In my April column, I recognised the benefits R&D organisations have realised from the first generation of ...
Delivery partners will have opportunity to shape sponsor IT strategy
Information technology investments in R&D will begin to target the ‘value analytics’ agenda, believes Deloitte 's Julian Remnant , and to do so, he suggests sponsors will increasingly draw on their delivery partners to shape operational IT strategy. The last ten years has seen industry-wide IT ...
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Partnerships in Clinical Trials
04 March 2012
The Marriott World Center, Orlando, Florida
