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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Early Trial Planning Solutions
Jun 21 | eCliniqua | Medidata announced two new products at the Drug Information Association (DIA) meeting this week in Washington, D.C.: an updated version of Grants Manager and Medidata Balance.
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Ludwig Institute Chooses Medidata EDC
May 19 | News Brief | Ludwig Institute for Cancer Research has chosen Medidata Rave as its electronic data capture and clinical data management solution.
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Integrating InForm EDC at Dana-Farber Cancer Institute
May 3 | eCliniqua | The Dana-Farber/Harvard Cancer Center, the largest cancer center in the United States, runs about 800 cancer clinical trials per year. And yet until 2000, all of those trials were tracked on paper, and researchers were still grappling with data gaps common to paper records.
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More than Data Integration: A Vision for “eClinical”
Mar 15 | Expert Commentary | The aim of integration of technologies is certainly the sharing of common datato ensure that all systems have the most up to date information, data don’t need to be re-keyed, and discrepancies are reconciled between applications.
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Implementing Core Clinical Trial Technologies
Feb 16 | Expert Commentary | In the clinical space today, more technology solutions are being used, and investigational sites often employ multiple solutions within a single study to perform their responsibilities. Solutions include clinical trials management systems, electronic data capture systems, electronic patient reported outcomes solutions, randomization and trial supply management solutions (typically deployed using IVR/IWR technology), medical imaging technologies, central ECG management and reporting solutions, adverse event and safety systems to name but a few.
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OmniComm Links EDC to HealthVault
Jan 27 | RFP Connect | OmniComm Systems has announced its TrialMaster EDC is now connected to Microsoft HealthVault.
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OmniComm Strives to be a Tier I eClinical Player
Oct 20 | OmniComm Systems is on a roll. In a few short years, it has essentially come from nowhere and is now positioned as the Number 3 electronic data capture (EDC) player.
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In Conversation: Oracle’s Patti Gaves on EDC and Integration
Oct 13 | In a recent conversation with industry veteran Patti Gaves of Oracle Health Sciences Global Business Unit, eCliniqua was curious about her perspective on the current status of electronic data capture (EDC), the industry’s strong focus on integration of electronic point solutions, and the evolution toward eClinical trials.
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Microsoft in Life Science Arena
Oct 5 | A few short months after naming Merck & Co. as a customer and development partner, Microsoft has attracted a sizable following to its life sciences platform intent on helping scientists design better drugs, sponsors better interpret clinical trial results, and physicians better match treatments to patients.
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Infinity’s EDC Evolution
July 7, 2009 | Last April Infinity Pharmaceuticals hit a major bump in the road when a review of the first few dozen patients in its Phase III trial for its lead compound prompted the company to instantly halt the trial. But Infinity still seems to be on the right track.
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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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