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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By eCliniqa Staff
May 4, 2009 | Last week at the Bio-IT World Conference & Expo, two clinical Best Practices Awards were given in the Clinical Trial anagement and Clinical Trial Design categories.
Genentech, nominated by ePharmaSolutions, won the Clinical Trial Management Best Practice Award for Clinical Trial Portal (CTP), a tool developed to streamline and accelerate workflow and collaboration between the stakeholders involved in conducting clinical trials. The CTP helps bio‐pharmaceutical companies accelerate and improve the site selection, activation, study training, trial management, adverse event management and patient enrollment process through a common technology platform that provides sites with one UserID, Passcode & URL for all of the studies they conduct.
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The winner in the Clinical Trial Design category was Wyeth Pharmaceuticals nominated by Tessella for “Design of Adaptive Clinical Trial with Adaptive Design Explorer.” Wyeth implemented a new framework, the Adaptive Design Explorer (ADE), in conjunction with Tessella and Berry Consultants. The ADE encourages designs to be developed in a parameterizable, generalized form that can be reparameterized for further subsequent trials. The ADE includes a graphical user interface (GUI) that is largely standard across all designs with one section for design specific parameters. This enables biostatisticians to learn to use a wide range of different designs quickly and easily learn new ones as they are added.
The 2009 awards mark the fifth Bio-IT World Best Practices Awards, and this year drew a record 72 entries, 20 in the two clinical categories. “These awards spotlight examples of the most outstanding innovations, technologies and practices in the fields of biomedical research, drug development and clinical research—spotlighting the tools and strategies that can make a difference in the conduct of basic and clinical research, speeding the drug discovery pipeline, and changing the way we generate, share, and analyze data and knowledge,” said Bio-IT World editor Kevin Davies at the gala awards dinner.
Full coverage of the Best Practices program and winners will appear in the July/August issue of Bio-IT World.
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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