Industry Trends

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Clinical Research
Off-shoring: A Country Attractiveness Index for Clinical Trials

By Mark P. Mathieu
For many years, pharmaceutical companies have been off-shoring manufacturing operations to lower-cost countries. Healthy margins and strong risk aversion have afforded pharmaceutical companies the luxury of staying close to home, for all but manufacturing activities. As financial pressures increase, pharmaceutical executives are finding that going offshore is not only less risky than it once was, but also too attractive to ignore.  Read More



Market Model for EDC in Clinical Trials

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William Blair & Company, L.L.C.
March 2009

We believe electronic data capture (EDC) vendors are positioned to benefit from the broad trend across the pharmaceutical industry to redesign the way drugs are discovered and tested. In recent years, as clinical trials have grown in size, complexity, and geographic reach, the inefficiency of using multiple processes to collect data has been magnified. Thus, we are not surprised to see many of the top pharmaceutical companies and CROs (such as GlaxoSmithKline, Merck, Novartis) move toward using EDC in 100% of their trials.

Given demonstrable cost and time-saving advantages, coupled with biopharmaceutical companies’ dire need to reduce time to market and cut excess costs, we believe EDC adoption has clearly reached a tipping point and we expect adoption to continue to ramp up quickly over the three to five years.

To test this theory, as a part of our CRO survey conducted toward the end of 2008 and early 2009, we included two questions dealing specifically with EDC adoption and the vendor of choice. We were surprised to see that nearly 45% of our respondents (n=18) already conduct more than 50% of their trials using EDC technology, and that three years from now, 85% expect to use EDC in 50% or more of their trials. Perhaps less surprising is that the two vendors identified most often as partners of choice were Phase Forward and Medidata.

Quantifying Market Growth—EDC Market Model

Our research of the EDC market indicated that there is a dearth of good data on the size of the market and the potential growth opportunity that exists. As a result, we have built a market model to estimate the current opportunity and future growth rates. In our view, three components to the growth of EDC-related spending will shape the industry in the coming years—new clinical trials, trial costs, and penetration rates—and we have incorporated these factors into our market model.

Based on our assumptions for trial growth, costs, and adoption rates, we believe the EDC market will grow roughly 15% per year through 2012—which compares with the 30%-35% growth reported by industry participants over the last few years. We believe the total addressable market (assuming 100% penetration) in 2007 was roughly $1 billion and expect that market to grow to roughly $1.4 billion in 2012. Taking penetration rates into account, we believe the 2007 market opportunity was roughly $330 million and expect it to increase to roughly $745 million in 2012, a CAGR of 15%.

 

A Market Model for EDC in Clinical Trials


StatSource_09-10_3D.jpgThe Industry Trend featured on this page was excerpted from

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White Papers & Special Reports

oracle_RDC
Remote Data Capture:Acquisition and Analysis
Sponsored by Oracle

See why Electronic Data Capture (EDC) is gaining traction in the pharmaceutical
clinical trials arena. Today approximately half of all clinical trials are conducted
electronically, and the figure is rapidly rising. Report includes contributions from
Oracle Health Sciences, Pfizer, PPD, and C3i.

 



oracle20723
The Role of Analytics in Transforming Healthcare
Sponsored by Oracle

Sharing many of the data challenges and opportunities faced by Healthcare, the Life Sciences industry remains focused on delivering new, innovative therapies and solutions to patients in a cost effective, timely and safe way. With spiraling R&D costs, new methods such as adaptive trials, and never ending need for deep pharmacovigilance, the Life Sciences companies that effectively use analytics to explore, monitor and optimize their business will rapidly become the new leaders.

Oracle’s strategy—built upon Enterprise Health Analytics and Health Data Warehouse Foundation—provides a powerful, practical, and extensible approach to delivering the IT analytics infrastructure required to confront the worldwide healthcare challenge.



pegasystems
BPM-Based Case Management Approach to Optimizing Clinical Trial Efficiency
Sponsored by Pegasystems

Business Process Management (BPM) software offers liberation in the planning and management of clinical trials today. SmartBPM provides the components for automating critical clinical trial processes ranging from protocol development and patient enrollment to site management and investigator payments. Advantages are:

  • Potentially stunning return on investment at multiple levels.
  • A 500%, or better, increase in application development time by directly executing business requirements
  • Improved customer retention
  • A 50% possible reduction in training time

Discovered is opportunity to enhance relationships with investigators, subjects, and regulators while bringing momentum to a technology-impaired study startup phase. Learn more about SmartBPM in this complimentary white paper.



Life Science Webcasts & Podcasts

Bio-IT World & CHI

Impact of the 1000 Genomes Project on the Next Wave of Pharmacogenomic Discovery
1000genomeInterview with M. Eileen Dolan, Ph.D., Professor, Medicine, University of Chicago and Speaker at Next-Generation Sequencing Data Management, September 27-29, 2010, Providence, RI  

The 1000 Genomes Project aims to provide detailed genetic variation data on >1000 genomes from worldwide populations using the next-generation sequencing technologies. Some of the samples utilized for the 1000 Genomes Project are the International Hap-Map samples that are composed of lymphoblastoid cell lines (LCLs) derived from individuals of different world populations. The detailed map of human genetic variation promised by the 1000 Genomes project will allow a more in-depth analysis of the contribution of genetic variation to drug response. Future studies utilizing this new resource can greatly enhance our understanding of the genetic basis of drug response and other complex traits.


Download Now 



More Podcasts

Job Openings

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Software Engineer – Computational Biology Center

Memorial Sloan-Kettering Cancer Center seeks an Engineer to design and develop complex data analysis systems in support of cancer genomics research projects at the Computational Biology Center. Qualified candidate will have a BA, 5+ years of software development experience and expert knowledge of Java, SQL, and HTML.

Apply: www.mskcciscareers.org.  Equal opportunity and affirmative action employer.




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