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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Most Approved Drugs Tested Overseas
Jun 23 | New York Times | The inspector general of the HHS released a report stating that 80% of the drugs approved for sale in 2008 had trials in foreign countries and 78% of all subjects that participated in clinical trials were enrolled at foreign sites.
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Choosing Countries for Oncology Trials
Jun 3 | News Brief | Premier Research Group has released a white paper that reviews a funnel-approach to selecting target countries for oncology trials
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Rosenberg: Make Adaptive Clinical Trials More Agile
Mar 15 | eCliniqua | Companies that actively embrace adaptive methods will be tomorrow’s leaders in the biopharmaceutical industry, says Michael Rosenberg, president and CEO of Health Decisions, and author of the recently released book, The Agile Approach to Adaptive Research.
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Oracle Clinical Development Analytics Could be a Game Changer
Feb 16 | eCliniqua | A clinical trial intelligence tool newly released by business software giant Oracle appears destined to boost R&D productivity and reshape interactions between industry sponsors and their multitude of partners aiding drug development.
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clinicalRSVP Detects and Stops Attempted Dual Enrollers
Feb 16 | eCliniqua | One of the more intractable problems in clinical research is identifying which subjects are attempting to enroll in more than one study at once or have failed to meet the required waiting period between studies. Independent Data Integrator (IDI), a Florida-based provider of IT solutions, is addressing the problem with its Clinical Research Subject Verification Program, or clinicalRSVP.
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Healogica to Exit Difficult Market for Online Trial Matchmakers
Feb 3 | eCliniqua | It’s an ostensibly sound idea: give the Internet-savvy masses a simple, high-speed search tool for navigating a comprehensive but cumbersome clinical trials listing website. But industry sponsors have deep reservations about the concept, effectively taking down at least two otherwise promising trial matchmaking services.
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Engaging E-Patients the BBK Way
July 20, 2009 | Clinical trial sponsors are largely unaware of the conflict that arises when dealing with the new, increasingly Internet savvy e-patient who is highly motivated, well educated, self-advocating, and self-informing, says Bonnie Brescia, of BBK Worldwide. “But the Internet is undermining that whole model.”
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The Case for Making All Studies Operationally ‘Adaptive’
July 20, 2009 | The time- and cost-saving benefits of adaptive clinical trials (ACT) will be lost on companies unless they can generate an uninterrupted flow of information on which adaptations will be based, says Mike Ford, head of data management at Health Decisions.
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Archimedes Turns Clinical Trial Models into Reality
June 22, 2009 | The Archimedes Model is a mathematical model that simulates human physiology (and the surrounding health care system) by creating virtual trial populations.
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Genentech’s Clinical Trial Portal Tightens Bond with Investigative Sites
June 15, 2009 | Genentech's relationship with investigative sites—from initial protocol and feasibility surveys to study training, site activation, patient referral tracking, and safety letter distribution—is being wholly managed through a single-sign-on Clinical Trial Portal (CTP).
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The Role of Analytics in Transforming Healthcare 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.
BPM-Based Case Management Approach to Optimizing Clinical Trial Efficiency 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.
Next-gen Cloud-based eClinical New technologies are available to leverage Cloud Computing in managing clinical trial data. This paper discusses a next generation eClinical
platform that: - Speeds trial set up
- Accommodates changes with zero downtime
- Integrates effectively with other clinical trial technology systems
It is offered with either software-as-a-service (SaaS), or turnkey infrastructure options in which the user organization operates their own cloud using their IT teams, within their data centers. Read this paper to learn and decide how best to leverage cloud computing’s many strengths for your organization’s particular needs.
Medidata Solutions
Evaluating a Risk-based Approach to Good Clinical Practice
.gif?n=6512 "medidata5_podcast") The verification of source documents by study monitors at investigational sites is considered a good clinical practice by regulatory authorities overseeing clinical research, and is extremely important to ensuring data quality in clinical trials. Today’s challenging environment is prompting study teams to explore the use of risk-based approaches to monitoring that do not compromise data quality, but allow limited resources to be directed more effectively to where they’re most needed and to the most critical review activities.
In this podcast, industry experts and executives from Medidata will address questions such as:
- Why are regulatory agencies and industry open to evaluating the new approaches in site monitoring and source document verification (SDV), and what attitudes and reactions towards less than 100% SDV?
- What factors do research sponsors need to consider in adopting risk-based site monitoring?
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More Podcasts
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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