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
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A.T. Kearney
March 2006
For many years, pharmaceutical companies have been offshoring manufacturing operations to lower-cost countries. Only recently, however, have they begun to look at other locations for clinical trials. Our discussions with senior executives reveal an unsettling trend: Rather than systematically benchmarking cost, demographics, regulations and infrastructure, they often use incomplete, anecdotal information to determine offshore locations. It’s time for a new approach.
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.
The offshoring potential is particularly significant for clinical trials, which account for as much as two-thirds of the cost of new drug development. Based on data from the FDA’s clinicaltrials.gov database (as of August 12, 2005), nearly half (48%) of all reported clinical trials conducted by pharmaceutical companies have a location outside the United States (see exhibit below).
 The Industry Trend featured on this page was excerpted from
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A BPM-Approach to Adverse Event Management Safety management is one of the most difficult requirements imposed on the life sciences industry. Companies confront a tangle of safety monitoring requirements that span both pre- and post-market approval activities and vary by IRB/IEC governance policies, product type, and different global regulatory agencies. Learn how Pegasystems BPM and its Adverse Event Case Processing Solution (AECP) can help companies - Transform adverse event management systems
- Lower cost with increased productivity
One client successfully utilized Pega BPM to establish paperless adverse event reporting across 23 countries, resulting in upwards of a 100% increase in productivity with near 50% cost reduction.
Embedding Oracle Technologies in Life Sciences Solutions Data drives science, but can slow it down. If data-structured or unstructured- is made more easily accessible, more easily shared, and more readily analyzed it will produce better results. In life science and healthcare that can mean the difference between a new drug finding its way to the healthcare market and patient, or simply getting lost in the data glut. Oracle's Embedded technologies can lower problematic data hurdles while producing innovation and productive outcomes. This paper discusses how Independent Software Vendors, Original Equipment Manufacturers and, of course, users can quickly and easily implement solutions that leverage Oracle embedded technologies.
The paper covers benefits for both vendors and users including: - Vendor advantages: Faster time to market, greater differentiation, customer satisfaction, enterprise class support and security.
- User advantages: Improved Data handling, faster clinical trials, improved business reporting, improved ROI.
 Meeting Today’s Challenges in Clinical Trial Supply Management
Sponsored by: Medidata Solutions Worldwide
Setting up and managing the clinical trial involves many complex procedures. Among the most challenging are planning and executing the logistics of the trial’s clinical supplies. This podcast focuses in depth on the following topics which trace current practices and future evolution of this crucial aspect of clinical trials:
- Current practices in clinical trial logistics
- Comparing advances in clinical supply practices to other aspects of clinical trials
- Where current practices fall short of meeting the challenges
- Trends and evolving improvements that may change the way logistics are conducted
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Tessella delivers software engineering and consulting services to leading pharmaceutical and biotech companies. We are recruiting Software Engineersto work with skilled bioinformaticians and scientists to identify business needs and recommend and develop technical solutions. Applicants require BS, MS or PhD in bioinformatics, biology or chemistry and 2+ years of software development in either: Java, C#, C++, C or VB.NET.
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Early Access Collaborations Managers
Oxford Nanopore Technologies is developing a novel technology, GridIONTM for the direct, electronic analysis of DNA/RNA and other analytes. As the system approaches the market, we are building a team of technically knowledgeable, highly motivated candidates with excellent customer service and facilitation skills to join our company as Collaboration Managers. This is a unique opportunity to work with world-leading genomics customers throughout the early adoption phase of a new generation of DNA sequencing technology.. This is a facilitative, enabling role with responsibility for managing technology development collaborations with key customers at leading genomics institutions. It will include long term management of the collaboration plan and milestones and associated meetings and documentation. Click here to find out more and apply
Oxford Nanopore's GridION technology, VP, Sales and Marketing Oxford Nanopore Technologies is a fast-moving technology company that is developing a novel electronic molecular analysis technology. The technology is adaptable for the analysis of DNA/RNA, proteins, chemicals and other molecules. It is therefore suitable for use in a variety of markets including scientific research and clinical applications. As the technology approaches the market, Oxford Nanopore is seeking a visionary VP of sales and marketing to join the senior team. The candidate will embrace the opportunities afforded by entering the market with a truly disruptive technology that has the potential to expand the number of users and the variety of applications in each target market. This is a rare opportunity to influence the commercial strategy at an early phase of its commercial lifetime, in a well funded company. Oxford Nanopore welcomes applications from candidates with a track record of high-level strategic commercial leadership, who wish to apply a fresh approach to existing markets. Experience in Life Sciences/DNA sequencing is central to this role, however we will consider your application if you have experience of disruptive technologies in other related industries. We are particularly interested in candidates with strong expertise in the use of digital technologies for sales and marketing of scientific/technical products. Click to Apply
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