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

Oracle Business Intelligence Enteprise Edition (OBIEE) for Clinical Trial Management System (CTMS)

Oracle Siebel CRM is the base application behind Oracle’s Siebel CTMS. Prepackaged OBIEE Applications does not have a module for Clinical Analytics and so there is a need to develop a complete custom OBI application in order to accomplish the requirements. This was untill Oracle has introduced Oracle Clinical Development Analytics (CDA) which is based on [...]

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 [...]

collaborative clinical trials management software for Central Laboratories

Laboratory Corporation of America Holdings…announced…a collaboration between Esoterix Clinical Trials Services, a division of LabCorp, and Clearstone Central Laboratories, a global central laboratory specializing in drug development and pharmaceutical services.…The collaboration provides LabCorp with access to Clearstone’s global network of labs, including China, France, Singapore and Canada, in addition to LabCorp’s existing labs in the [...]

MNC Pharma tries to capture the $1.9 billion Indian OTC market by selling Drugs through India’s 170000 post offices

The multinational pharma companies are planning to approach the health ministry with a proposal calling for the utilisation of the 1.7 lakh post offices across the country to distribute over the counter drugs. The move if implemented would increase the reach of OTC drugs by 20%. The plan initially submiited 2 years ago requires  the approval [...]

Scott Stern Kellogg School of Management speaks about “New Drug Development: From Laboratory to Blockbuster to Generic,”

Scott Stern, Associate Professor, Kellogg School of Management, speaks on the topic of, “New Drug Development: From Laboratory to Blockbuster to Generic,” at the Judicial Symposium on The Pharmaceutical Industry: Economics, Regulation, and Legal Issues, hosted by the Northwestern Law Judicial Education Program

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 [...]

SalesForce.com partner introduces CRM for clinical trial management on Force Platform

Had an interesting chat with the CEO of the US based IT service provider for clinical research industry in June. Apparently the company a SalesForce.com partner introduces new CTMS application in India. Just came to know that they are going commercial this month. The applications is aimed at clinical trial management, Study site management and Patient Recruitment [...]

Harvard Medical Schools new automated safety surveillance system provides faster early warnings in the postmarket evaluation of medical device safety

Implementation of a computer-automated safety surveillance system of clinical outcomes registries for cardiovascular devices resulted in the identification of a drug-releasing stent that had significantly higher rates of major adverse cardiac events than similar stents “Monitoring the safety of approved medical products is of vital public health importance, given that in clinical practice such medical [...]

FDA has poor oversight in medical device monitoring and post market surveillance

According to a British Medical Journal, article on the effectiveness of post-market surveillance, medical device manufacturers “often fail to properly conduct safety studies” and the Food and Drug Administration (FDA) “provides scant oversight” in post-approval monitoring of these devices. The article is published by Jeanne Lenzer and Shannon Brownlee, called  “Why the FDA can’t protect [...]

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 [...]

Site Coordinator’s Role in Clinical Trials Success

Industry Standard Research (ISR) today announced the launch of a new and substantial research report titled “The Voice of the Site Coordinator.” This report presents data and analysis from 124 interviews with Study / Site Coordinators from the US, Europe, Latin America, and Asia. Kevin Olson, CEO, Industry Standard Research. Olson says “Our data suggest that [...]

Indian Goverment’s Department of Science and Technology launches enhanced clinical research units in colleges

The Department of Science and Technology (DST) will set up enhanced clinical research units in select colleges across India , Delivering the valedictory address at the International Conference on Radiation Biology hosted by Sri Ramachandra University, DST Secretary  T. Ramasami said the idea behind the joint inter-agency initiative that also involved the Indian Council of [...]

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 [...]

Eli Lilly CIO Michael Heim says Lilly will increase use of cloud computing in clinical data management

Eli Lilly’s CIO Michael Heim says that the drug giant’s right to know where in the cloud its data resides, and to know the provider’s disaster recovery plans are chief issues that will drive the use of cloud computing in clinical data within drug discovery and development projects. An interview with Michael Heim is available [...]

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 [...]

personalized medicine might be making drug development more complicated

According to a new report from the Tufts Center for the Study of Drug Development at Tufts University 12 to 50 percent of the drugs companies are developing, depending on the company, involved a personalized medicine approach. The Tufts report is based on a survey of 25 companies, large and small, to which 16 companies [...]

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 [...]