Clinical Research Sites Struggle With Increasing Trial Complexity yet most depend on, Google (or other search sites) as the primary information tool

A new survey of 500+ clinical research site professionals outlines the  impact of complex, clinical trials in clinical trial sites. The survey focused on 3-year trial trends and found key challenges in subject recruitment/retention and tracking and reporting data. Increased complexity also impacted trial financials– especially negotiating contracts and managing profitability. The December, 2010 survey [...]

PharmaNet unveils touch screen capable data capture platform for Phase I Clinical Trials

The implementation of this platform enables rapid study set-up, automated CRF generation and better study recruitment and communication tools for general and special populations. Mobile workstations allow for rapid data entry and data is captured directly using bar codes and interfaces to medical equipment, such as blood pressure monitors. The Initiator platform also interfaces with [...]

Sanofi-Aventis ties up with Oxford Univ for oncology research in India

Sanofi-Aventis and Oxford University have entered into an agreement with INDOX, an academic oncology network to conduct oncology clinical and translation research in India. The company said that through this partnership, Sanofi-Aventis will have access to experience and expertise of India’s top oncologists which will help the company in conducting clinical research. “The collaboration between sanofi-aventis, [...]

trends in the life sciences and pharma research and development outsourcing (RDO)

Vicki Phelan, Managing Director, Pharmaceutical and Life Sciences Practice with Stan Lepeak, Managing Director, Global Research Trends in the life sciences and pharma research and development  outsourcing (RDO) The complete report is available at http://goo.gl/MgVBu

Microsoft in Clinical Trials Management System (CTMS) and Electronic Data Capture (EDC)

one of the very few interesting article by Microsoft Engineers on Clinical Research Industry. Certainly interesting as it is written by none other than      Les Jordan-CTO, Life Sciences Industry Unit at Microsoft . Microsoft and IBM had much longer and deepr association with Lifescience/Healthcare/Bioinformatics industry than Oracle. But I love to see microsoft [...]

Clinical Trial and Pharmacovigilance process automation

I had posted last month about the Pegasystem pharmacovigilance solution. Pega Systems the industry leader in Business Process Management (BPM) software solutions, released a Pharmacovigilance case processing software. Pega has experience in clinical trial space, specifically in Clinical Trial Management. The solution is designed for rapid deployment to quickly leverage existing adverse event processing rules and requirements and can [...]

Widespread fraud in the Clinical Trial of Drugs is pervasive event in United States

There have been several cases where Fraud in clinical trial has questioned the  Integrity of Data and ethics , when conducting clinical trial in India, which have been used by crusaders against outsourcing. But the new evidence suggest that the clinical trial fraud is more prevalent even in US. The most recent being MannKind Corporation Accused [...]

Health Council of Canada says some prescription drugs approved for use in Canada may be less safe than consumers think, due to poor Pharmacovigilance/Post Market Surveillance rules

Canada’s Food and Drugs Act relies on drug companies to submit adverse reaction reports, which drug users submit if they suspect they are experiencing negative side effects. Drug users also can submit the reports directly to Health Canada, but it still leaves the government to rely on outside parties to report problems. In 2009, Health [...]

Chinese drug discovery market predicted to grow 23% per annum

China’s health and medical industry is advancing rapdily within genomics, combinatorial chemistry and high-throughput screening, China has been recognised as an important location to which drug discovery is being outsourced. The Chinese drug discovery market reached US$315.0 million in 2009 and is predicted to expand at a compound annual growth rate of 23% from 2009 to [...]

Clinical approval success highest for smallest firms among the top 50 Pharmaceutial companies

The top 10 pharmaceutical companies out of the world’s top 50 have lower estimated overall clinical approval success rates than do smaller firms in that group, but nonetheless appeared to have some R&D productivity advantages, according to a new study completed by the Tufts Center for the Study of Drug Development. Despite experiencing lower overall [...]

Paper instead ‘chips’ may be used as medical testing devices to fight disease

George Whitesides, a Harvard chemistry professor has designed technology in which patients’ blood is dropped on a piece of paper, and water-repellent ink resembling that of a comic book creates diagnostic colors on the other side, CNN reports. The technology may be incorporated into mobile phones, according to CNN. Whitesides’ prototype allows for testing of [...]

UK’s Medical Research Council grants Clinical Research consortium $6.4 million to develop chips & software to use mobile phones/PCs as testing devices for sexually transmitted disease (STD)

UK’s Medical Research Council grants a Clinical Research consortium $6.4 million to develop chips & software to use mobile phones/PCs as testing devices for sexually transmitted disease (STD) If successful individuals will drop their blood, urine or saliva on a mobile chip, which they then insert into a mobile phone or PC. Software on the [...]

Life Sciences at Oracle Open World 2010

Learn more about the strategic dynamics of Life Sciences at Oracle Open World 2010, from September 19-23. Attend the Life Sciences track to learn how Oracle’s powerful combination of technology and comprehensive business applications can help you address key challenges such as costly, high-risk discovery periods and shrinking patent expiration limits. Leading life sciences organizations will discuss how [...]

How should you safely outsource pharmacovigilance to an Indian contract research organization?

Published in hte Indian Journal of Pharmacology. Edwards B. How should you safely outsource pharmacovigilance to an Indian contract research organization?. Indian J Pharmacol 2008;40:24-7 The articles focus on different types of CRO that operate in India and the concerns western companies should address before deciding to oursource the trial to Indian companies. exerpts from [...]

First Chinese Clinical Research Outsourcing Industry Standard Under Development

According to information from the The Contract Research Organization Union China (CROU) under the China National Pharmaceutical Technology Market Association, it is developing the first industry standard for the Chinese CRO sector, Guidelines for Clinical Trial Services of Contract Research Organizations. Currently drafting of the document is already completed and it is likely to be [...]

Translational Research: From Bench to Bedside

‘Translational Research: From Bench to Bedside’ Capitol Hill Breakfast Briefing Hosted by the Council for American Medical Innovation The Briefing is the second in a three-part series on “Achieving Recovery Through Discovery” This is the second in a three-part briefing series examining the role of public policy in promoting medical innovation to help our nation [...]

Oracle’s 3rd Annual Drug Development and Safety Forum 2009- India

Oracle’s 3rd Annual Drug Development and Safety Forum 2009 October 21 – 22, 2009 Oracle invites you to the 2009 Drug Development and Safety Forum At this forum we will be discussing important topics and issues facing the Indian Pharmaceutical Biotechnology, and CRO industry. This event will be highlighted by presentations from key industry thought [...]

India to implement E-Governance for Clinical Trials

The health ministry of India  is planning to introduce e-governance for clinical trials in four years. The move will enable drug companies that want to carry out clinical trials in India to register online from any part of the world. Once the required approval for conducting trials is obtained, the companies can also submit research [...]

Hollywood, bollywood and the thing called Clinical Trial

Whats the relationship among hollywood and clinical trial, only thinng I could think of is controversy, money and perhaps the uncertainity of success or failure. I am not aware of any celebrity ever being part of a clinical trial project , till this date. In emrging market (read the BRIC countires) human watch groups accuse [...]

Zimbabwe boosting Clinical research with US Training

The country’s clinical research programme has received a massive boost following the unveiling of an exchange programme that shall see University of Zimbabwe postgraduate students receiving further research training in HIV and AIDS clinical trials at the University of Buffalo in the United States. The country’s clinical research programme has received a massive boost following [...]