The News Review:

- Global Research Services Announces Strategic Alliance Agreement with …
- Netherlands Corporate News – Medidata Solutions breidt aanbod…
- Home > Business > PTT chemical and scg join hands with universit…
- Report 6 of the Council on Scientific Affairs (A-05)
- Body Mass Index Higher Among Bariatric Surgery Patients With 2…
- Appendix Removed Via Mouth; First Such Surgery In US

Global Research Services Announces Strategic Alliance Agreement with …
Earthtimes – Mar 17, 2008
The agreement authorizes GRS to utilize CardioDynamics’ impedance cardiography (ICG) technology for advanced processing of noninvasive hemodynamic ICG data. CardioDynamics ICG products enable GRS to provide expanded biometrics and data management services in support of clinical trials. Combining the strengths of both companies will allow biotechnology pharmaceutical and device companies and clinical research sites to obtain the benefits of enhanced cardiac safety monitoring in Phase I through IV clinical trials. GRS has recently completed several programs using this state of the art technology to rapidly upload data from CardioDynamics’ proprietary BioZ® ICG technology and BioZport® application software. Investigators and sponsors can easily view reports and detailed cardiovascular tables and graphs created from real-time trial data through secure online portals assisting in faster decisions related to dose selection safety outcomes and therapeutic efficacy of cardio-active agents. CardioDynamics’ proprietary BioZport® application software was designed to meet FDA’s 21 CFR Part 11 and HIPAA requirements and provides real-time transmission of ICG data for rapid assessment of both desired and adverse effects of candidate compounds. With the increasing focus of regulatory agencies on cardiac safety assessment of new compounds CardioDynamics and GRS are pleased to provide this enhanced capability to the clinical trial market.

Netherlands Corporate News – Medidata Solutions breidt aanbod…
Netherlands Corporate News – Netherlands Corporate News (persbericht) – Mar 17, 2008
“Individually each product in theMedidata portfolio improves the effectiveness of key trial planningand execution activities. As a combined company we are able to helpcustomers and partners realize greater value from their eClinicalstrategy by putting innovative technology and insightful data intoresearchers’ hands to facilitate their decision-making. Reaching More Members of the Clinical Research Team with NewCapabilities Medidata has built its reputation among investigators and datamanagers for streamlining the clinical trial process through Rave’seasy-to-use data capture management and reporting capabilities. Medidata’s expanded product portfolio now also offers protocoldevelopment trial management and finance teams a consistent view ofthe critical operational data generated throughout the clinical trialexecution process. — Medidata Designer(TM) (formerly Fast Track TrialSpace Designer XCP(R)) – This cutting-edge protocol authoring and trial design tool helps guide clinical research teams through the protocol creation and study set-up processes. Beginning with structured protocol development Medidata Designer can automatically configure other clinical trial systems – such as electronic data capture and management data analysis and electronic data submissions – ensuring an automated environment for consistent shared clinical and operational requirements. Medidata Designer: — Deploys a standardized protocol development methodology that assures quality consistency and continuity of trial protocols to more effectively execute the clinical plan; — Retains organizational knowledge and builds company standards by populating a protocol warehouse with consistent study design parameters; and — Facilitates compliance with CDISC SDTM data submission standards with the only CDISC-certified protocol authoring tool.

Home > Business > PTT chemical and scg join hands with universit…
Nation Multimedia – Mar 17, 2008
Chulalongkorn is also seeking strong partners to expand its research expertise. A partnership with the University of Nagoya allows the company to conduct R&D for components specially made for vehicles distributed in Southeast Asia for Toyota. The university has also launched Asia Pacific CR in collaboration with the Netherlands' leading research company IATEC as the first in Thailand to provide full-circle clinical research services. This paves the way for Chulalongkorn to conduct clinical research for major pharmaceutical companies. Achara DeboonmeChularat SaengpassaThe Nation.

Report 6 of the Council on Scientific Affairs (A-05)
American Medical News – American Medical News (subscription) – Mar 17, 2008
Several steps can be taken immediately to improve drug safety and reduce the knowledge gap between the FDA and physicians about the risks and benefits of certain drug products. Chief among these are steps to establish a more transparent process with respect to clinical research data obtained by the FDA. This process can be enhanced by the development of a comprehensive clinical trial registry creation of an independent drug safety board within the FDA better risk communication for marketed products the use of more active and directed postmarketing surveillance activities and conducting mandatory postmarketing studies where needed. RECMMENDATINS The following statements recommended by the Council on Scientific Affairs were adopted by the AMA House of Delegates as AMA directives at the 2005 AMA Annual Meeting: The AMA: Urges the Food and Drug Administration (FDA) to issue a final rule as soon as possible implementing modifications to the format and content of the prescription drug package insert with the goal of making the information more useful and user-friendly to physicians. (Directive) Urges the FDA to collaborate with physician organizations to develop better risk communication vehicles and approaches. (Directive) Urges the FDA to apply new tools to gather data after drugs are approved for marketing including a broader use of targeted post-approval studies institution of active and sentinel event surveillance and data mining of available drug utilization databases.

Body Mass Index Higher Among Bariatric Surgery Patients With 2…
Science Daily – Science Daily (press release) – Mar 17, 2008
This subgroup may carry genetic susceptibilities to obesity that overcome the effects of bypass surgery. "The identification of such susceptibility genes may therefore be important in identifying patients at high risk for postoperative weight gain. These studies may also represent some of the first specific examples of ‘surgicogenomics’ paralleling the well-developed field of pharmacogenomics" or using genetic information to predict individuals’ responses to medications. Journal reference: Arch Surg. 2008;143[3]:235-240. This study was supported by the Geisinger Clinical Research Fund. Adapted from materials provided by.

Appendix Removed Via Mouth; First Such Surgery In US
Science Daily – Science Daily (press release) – Mar 17, 2008
17 2008) — n Wednesday March 12 2008 surgeons at UC San Diego Medical Center performed what is believed to be the country’s first removal of a diseased appendix through the mouth. This clinical trial procedure received approval for a limited number of patients by UC San Diego’s Institutional Review Board (IRB) which oversees clinical research. See also:Health & MedicineToday’s HealthcareCosmetic SurgeryDiet and Weight LossLung DiseasebesityMedical ImagingReference.