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 [...]

AstraZeneca Announce Real-World Evidence Data Collaboration

AstraZeneca Pharmaceuticals LP (NYSE: AZN) and HealthCore, Inc., the health outcomes research subsidiary of WellPoint, Inc. (NYSE: WLP), announced a collaborative agreement to conduct real-world studies designed to determine how to most effectively and economically treat disease Unlike controlled clinical trials, real-world evidence studies use observational data such as electronic medical records, claims information and [...]

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

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 [...]

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

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 [...]

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 [...]

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 [...]

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 [...]

How useful would be the Single-patient clinical trials for improving the hopes of Personalized medicine

Single patient Clinical Trial are not new idea, FDA did not focus since such trial canot prove the efficacy and safety of medicine over a large pool of patient with sufficient data. But I was forced to re-think after reading the article http://www.technologyreview.in/biomedicine/12537/ why cant we use the the concept mentioned in to overcome the [...]

GSK, MedTrust launch iPhone/iPad app for cancer trials

GlaxoSmithKline has teamed up with MedTrust Online,  provider of specialist data and technology to oncologists, to launch CancerTrialsApp, described as “the first free geo locating cancer clinical trials application” for the Apple iPhone and iPad. The application enables cancer doctors to find and share with their patients information about experimental therapies in clinical trials

Indian Government to make biometric ID mandatory for clinical trials

Hit with allegations in the western media about unethical practices in conducting clinical trials, The Indian government and regulatory authorities are making a bolder move planning mandatory biometric identification for clinical trial volunteers in India. The Ministry of Health and Family Welfare plans to ask all clinical research organisations to enforce biometric identification for the [...]

India looses USD 1 Billion Investment in Drug R&D to China due to lax Indian patent laws-

Did I really read the news correct or was I just plain drunk on a weekend while reading it. Turns out it is true. Just a week after the Novartis CEO has blasted the Indian IP laws, Novartis has announced plans to invest 1 Billion US Dollar in China for Drug Discovery and Developement. The [...]

India begins serious efforts to ensure patient safety- Rejoice if you are in US Obama is going to penalize hospitals with high one-month readmission rates for transitioned patients

MUMBAI: A mop left inside a patient’s stomach after a surgery, an expired drug administered to an ailing person or a hospital-acquired infection-medical errors are a nightmare for both doctors and patients. Such incidents, which are usually swept under the carpet, will now be recorded and reported to an independent body in India. This will [...]

Data Management and Integration for the Future of Clinical Trials webcast

Upcoming Webcast: Data Management and Integration for the Future of Clinical Trials Attend this interactive webcast presented by Applied Clinical Trials and Oracle Health Sciences featuring speaker Tom O’Leary, Senior Vice President, Data Management, ICON Clinical Research and Claire Castaings, Vice President Worldwide Director, Clinical Data Management Sanofi-Aventis. This session examines the use of the [...]