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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invivodata: FDA’s New PRO Guidance Highlights Patient’s Perspective
May 17 | eCliniqua | Evidence is mounting that the Food and Drug Administration (FDA) wants to hear the voice of the patient in clinical trials. "They want to make sure PRO data are collected in a reliable way so they can make reasonable judgments based on those data,” says Doug Engfer, president and CEO of invivodata.
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Harnessing (and Securing) Meaningful Health Data
May 3 | eCliniqua | “There isn’t going to be some massive database in the basement of the White House run by Sarah Palin,” promised John Halamka, the CIO of Harvard Medical School, in his keynote at the Bio-IT World Expo.
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The Reality of Medical Software Compliance
Jan 19 | Expert Commentary | “It is estimated that 60% of the computer systems containing patient medical records currently in use within the United States are not in compliance with the industry standards for security, audit trails, and electronic signatures,” states industry expert David Nettleton, FDA Compliance Specialist, of Computer System Validation.
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Peddicord: New Privacy Concerns with ‘HIPAA 2’
Jan 4 | eCliniqua | A new set of federal privacy and security requirements, introduced by legislation promoting the adoption of electronic health records (EHRs), “may make the investigator-CRO interface more complicated for some time.”
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Adverse Event Reporting Begins at Clinicaltrials.gov
Sep 21 | Starting on September 27, sponsors of industry-, academic- and government-run clinical trials will have to begin reporting adverse events on www.clinicaltrials.gov.
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BioClinica Acquires Tourtellotte Solutions
Sep 21 | BioClinica has acquired Tourtellotte Solutions, best known for its supply chain simulation and interactive voice (IVR)/interactive web (IWR) software.
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Will Regulated Product Submission (RPS) Trump eCTD?
June 26, 2009 | Just as the electronic common technical document (eCTD) is gaining traction as the required format for electronic regulatory submissions, the FDA is changing the game.
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Phase Forward Helps FDA, DoD Monitor Drug Safety
eCliniqua | The Department of Defense last year chose Phase Forward’s Lincoln Safety Group to support a new drug safety initiative, enabling it to provide the FDA with rapid assessment capabilities.
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Workgroup Sets Priorities to Harmonize Standards for EHRs and Research
eCliniqua | The much anticipated convergence of data between clinical trials and electronic health records (EHR) is heading toward reality with the recent formation of the EHR Clinical Research Value Case Workgroup.
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Etrials Purchase Would Make BioClinica Number Three EDC Player
May 8, 2009 | What reputable products and a succession of management teams couldn’t do for etrials Worldwide its soon to be owner most likely can boost stagnating sales and stem the red ink.
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 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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More Podcasts
Scientific Software Engineer
Boston MA
$70,000 to $95,000
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.
Apply at http://jobs.tessella.com
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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