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LATEST NEWS
CRO employees face jail after recruiting their own staff
06 June 2011
In a cautionary tale for any firm tempted to cut corners when patients prove hard to find, two employees of a small American CRO, including its former director of clinical trials, are currently in the dock after being accused by US Federal prosecutors of sneaking their own employees on to an ...
Investigator payment tool selected by Clinverse
03 June 2011
Clinical trial technology company Clinverse has joined Medidata 's technology partner programme, and will use Medidata's ClinPay eClinical commerce network and the Medidata Rave system for clinical data capture, management and reporting. Using the firm's programming interfaces, automatic data ...
US FDA gets tough on financial disclosures by clinical investigators
31 May 2011
The US Food and Drug Administration has substantially revised its guidance on the disclosure of financial interests by clinical investigators and is seeking stakeholder feedback on the draft document. The revised guidance addresses concerns that the FDA does not do enough to guard against ...
Quintiles partners in South Korea for investigator training
31 May 2011
To continue the growth of investigator education in in Asia, Quintiles is to partner with the Korea National Enterprise for Clinical Trials (KoNECT) to produce educational events for investigators, local and multi-national biopharmaceutical companies and relevant government officials. Established ...
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FEATURES
Investigator insights: CRO or sponsor preference
25 November 2010
The use of CROs is a widely accepted practice in the clinical development of new and marketed drugs. For example a survey conducted by University of the Sciences in Philadelphia (USciences) and TTC confirms that only 36% of all post Phase I studies are managed entirely in-house. CROs are used in a ...
Optimising the site budget in a diverse and rocky world
24 November 2010
The current economic recession began in December 2007, and by most analyst accounts, the global economy has not yet fully recovered. In the biopharmaceutical industry, R&D spend has risen every year from 1970 - 2008, with the total global annual R&D spend increasing to over $65 billion in 2009, up ...
Automating investigator payments: remove the pain and cut the cost
23 November 2010
There are very few aspects of life which remain untouched by the silicon revolution. And as time passes it becomes increasingly difficult to think of examples of processes which remain "unenhanced" by the ubiquitous computer. We no longer need cash because we have a credit card (or two) with a chip ...
Surviving the nasty surprise of investigator fraud
19 November 2010
A few months ago, the prominent and pioneering anaesthesiologist Scott Reuben , chief of acute pain at Baystate Medical Centre, was sentenced to six months in prison for falsifying the data in, or entirely inventing, dozens of clinical trials. In the end, what caught Reuben was an audit of two ...
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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
