Search:
Main Menu
Login | RSS |

BioPharmArena.com

News, Topics and Careers in Biopharmaceuticals and Biotechnology

Globalization Of Clinical Trials Makes Case For Clinical Trial Management Systems

August 15th, 2008 by Barry - Admin BioPharmArena

Contract research organizations (CROs) hope to obtain an edge in the highly competitive healthcare industry by using technology to shorten project times, improve data quality, and thus, differentiate services. As clinical trials globalize, sponsor companies and CROs increasingly look for tools that will help them simultaneously view, manage and discuss these trials across multiple sites. New analysis from Frost & Sullivan, U.S. Clinical Trial Management Systems Markets, finds that market earned revenues of $237.6 million in 2007 and estimates to grow at a compound annual growth rate of 14.5 percent between 2007 and 2014.

Clinical trial management systems (CTMS) have emerged as the best-suited solution to provide this competitive advantage to CROs. These tools will also enable the CRO to collaborate with clients and contribute key information that enhances data quality.

CTMS employs intelligent applications and access to clean data. This helps users improve overall efficiency and shortens trial timelines, lowering overall cost through better utilization of resources. In addition, the systems use automated data checks to ensure reliability of data, thereby reducing the need for expensive back-end queries and reconciliation.

“CTMS has the potential to enable decision making and improve patient safety protection,” notes Frost & Sullivan Research Analyst Barath Shankar S. “The success of implementing electronic data capture (EDC) solutions is a strong driver for the implementation of CTMS solutions.”

CROs are under increased pressure to explain the rapid rise in the number of post-marketing adverse events. This drives them to invest in tools that capture and manage trial data more effectively.

While this trend likely pleases vendors of the highly dynamic CMTS market, participants must also prepare for the eventual maturing of the market. Henceforth, system vendors will increasingly deal directly with CROs, which will be primary decision makers while choosing the vendor.

Additionally, CROs will be conscientious while selecting a CMTS vendor to conduct business with, since sponsors will prefer CROs that function as a one-stop shop and offer integrated solutions for running and managing trials.

“Meanwhile, the cost and resource implications for smaller CROs and BioPharma companies in CTMS implementation are significant,” notes Shankar. “It is important to account for hidden costs while calculating the total cost of deployment and operation of CTMS solutions.”

U.S. Clinical Trial Management Systems Markets is part of the Pharmaceutical & Clinical Diagnostics Growth Partnership Service program, which also includes research in the following markets: global pharmaceutical contract manufacturing markets, global CRO spending trends, and U.S. drug discovery CRO markets. All research services included in subscriptions provide detailed market opportunities and industry trends that have been evaluated following extensive interviews with market participants. Interviews with the press are available.

Frost & Sullivan, the Growth Partnership Company, partners with clients to accelerate their growth. The company’s TEAM Research, Growth Consulting and Growth Team Membership empower clients to create a growth-focused culture that generates, evaluates and implements effective growth strategies. Frost & Sullivan employs over 45 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from more than 30 offices on six continents.

Frost & Sullivan

Medicalnewstoday.com

Posted in Clinical Data Management, Clinical Research and Clincal Trials | No Comments »

Oramed Pharmaceuticals Announces Successful Phase 2A Clinical Trial Of Its Oral Insulin Capsule

August 10th, 2008 by Barry - Admin BioPharmArena

Oramed Pharmaceuticals, Inc. (OTCBB: ORMP.OB), a developer of oral delivery systems, announced successful results from the clinical trial of its oral insulin capsule, ORMD 0801. The trial demonstrated that the product had a good safety profile and well tolerated and effective in lowering blood glucose levels in patients with type 2 diabetes.

The study was conducted at Hadassah University Medical Center in Jerusalem and was a continuation of the successful Phase 1B trials that Oramed completed earlier this year.

This trial was the first to expose patients with type 2 diabetes to ORMD 0801 and its primary goals were to assess the safety, tolerability and pharmcodynamic effects in these patients.

ORMD 0801 was well tolerated by all patients and had a good safety profile; no serious adverse events were encountered throughout the study. In 6 of the 9 subjects analyzed, statistically significant reductions in glucose as well as C-peptide were observed.

Read more ….

MedicalNewsToday.com

Posted in Clinical Research and Clincal Trials | No Comments »