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HEADLINE NEWS
33 drugs 'approved without trials in India'; parliament cites Merck, Lilly, GSK, Novartis
09 May 2012
In what's seen as one of the most damning reports on the industry and regulatory mechanism in India in recent times, a parliamentary committee in the country has charged that more than 30 new drugs were approved without undergoing clinical trials. Products mentioned in the parliamentary report as ...
Trials on trial: 'short-term pain' needed for broken clinical enterprise
09 May 2012
A comprehensive redesign of the entire clinical trial enterprise must be considered if we are to tackle the deficit of evidence underpinning clinical practice guidelines, say researchers from Duke University in JAMA. While this would involve "some short-term pain", lead researcher Robert ...
Quintiles revs up offering to reflect 'dramatic' changes in Asia Pacific
08 May 2012
Quintiles, the world's leading biopharmaceutical services company, appears set to scale up its Indian activity in consulting and capital services and partnering in biosimilars. Such plans underscore the growing importance of the Asia Pacific region for drug development, despite some regulatory ...
US FDA finalises rules on disqualifying clinical investigators
04 May 2012
The US Food and Drug Administration is tightening its rules to ensure that clinical investigators who have been disqualified from carrying out research on one type of FDA-regulated product (eg a medical device) do not carry out research on a different type of product (eg a drug). The amendment, ...
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NEWS
INC Research expands clinical partnership with Medidata
09 May 2012
INC Research has broadened its services around Medidata Solutions’ clinical cloud platform by attaining three new accreditations. It now offers implementation and management services for Medidata Balance, Medidata Rave Targeted SDV and Medidata Coder. In 2006, INC Research became one of the first ...
33 drugs 'approved without trials in India'; parliament cites Merck, Lilly, GSK, Novartis
09 May 2012
In what's seen as one of the most damning reports on the industry and regulatory mechanism in India in recent times, a parliamentary committee in the country has charged that more than 30 new drugs were approved without undergoing clinical trials. Products mentioned in the parliamentary report as ...
Trials on trial: 'short-term pain' needed for broken clinical enterprise
09 May 2012
A comprehensive redesign of the entire clinical trial enterprise must be considered if we are to tackle the deficit of evidence underpinning clinical practice guidelines, say researchers from Duke University in JAMA. While this would involve "some short-term pain", lead researcher Robert ...
Quintiles revs up offering to reflect 'dramatic' changes in Asia Pacific
08 May 2012
Quintiles, the world's leading biopharmaceutical services company, appears set to scale up its Indian activity in consulting and capital services and partnering in biosimilars. Such plans underscore the growing importance of the Asia Pacific region for drug development, despite some regulatory ...
US FDA finalises rules on disqualifying clinical investigators
04 May 2012
The US Food and Drug Administration is tightening its rules to ensure that clinical investigators who have been disqualified from carrying out research on one type of FDA-regulated product (eg a medical device) do not carry out research on a different type of product (eg a drug). The amendment, ...
>> More News...
FEATURES
Nimble partnerships in the pharma industry
17 May 2012
Over the past 30 years, pharmaceutical companies have grown into behemoths, continually extending the scope and scale of their operations through megamergers and global expansion. Strong revenues and profits allowed them to fund big, broad businesses. They did it all—from discovering new molecules ...
Migraine segment remains dynamic
17 May 2012
Last month (May 2012), the UK’s National Institute for Health and Clinical Excellence (NICE) announced it was minded to recommend that Allergan ’s Botox (onabotulinumtoxinA) be available for treating migraine patients within the UK National Health Service (NHS). If NICE gives the final go-ahead, ...
Withered in Oz, a tale of research rejuvenation
09 May 2012
Despite its small market size, Australia has traditionally attracted more than its fair share of international clinical trials. But business hasn’t been so good over the last few years. The number of new trials conducted in the country fell by 34% between 2007 and 2010, and yet investment in ...
Research sponsors shuffle the deck with preferred CRO research
03 May 2012
The M&A activity that dominated the CRO landscape last year has meant that the top five CROs that usually take the lead in the sponsors' view of the industry has been extended to the top seven: Quintiles , Parexel , Covance , PPD , ICON , INC Research and PharmaNet/i3 (inVentiv), according to new ...
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PEOPLE
Aptiv appoints Luis Gutierrez as EVP
Aptiv Solutions has hired Luis T Gutierrez, Jr as executive vice-president and chief commercial officer. In this role, he will oversee the global business development, proposal development, marketing and brand management functions at Aptiv Solutions. Gutierrez brings more than 25 years of industry ...
AMRI appoints William Marth to board
Albany Molecular Research (AMRI), a leading global contract research and manufacturing organisation, has appointed William Marth to its board of directors. He takes the place of Dr Paul Anderson , who will not stand for re-election at the upcoming annual meeting of shareholders scheduled for 6 ...
Edward Ian hired at Theorem for Asia role
The CRO Theorem Clinical Research has hired Edward Ian as executive director, clinical development, for the Asia-Pacific region within the Taiwan office. Ian previously served as the vice-president of the Asia-Pacific region for PPD and as the executive director of scientific affairs for the ...
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COMMENTARY
Beyond clinical trials - bringing big technology to the table
Companies that provide technology-enabled solutions that improve the quality and efficiency of clinical trials could soon find themselves attractive partners or acquisition targets for new entrants to the healthcare space. The potential to leverage clinical trial technologies such as ePRO to ...
Is the site an out-dated concept?
Research sites behave as though they ‘own’ patients, but of course they don’t, they are only gate keepers. Patients are fully in charge of their own medical care and are the final arbiters of whether they would like to participate in a clinical trial or not. It would make sense then, to assume that ...
Starter for 10: considerations when using off-shore locations to support clinical trials
There has been increased interest across the life sciences industry to use lower-cost regions such as India, China, Eastern Europe, South America and South Africa to support functions including data management, programming, statistics, pharmacovigilance and medical writing across drug development ...
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 ...
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Clinical Operations Summit
23 May 2012
Brussels, Belgium
