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By BIO-IT World
The safety-reporting and pharmacovigilance niche is served by both specialty vendors and EDC companies. Homegrown applications created by and for sponsors are still a major factor.
| Dealing With ... |
Commercial Tools Can ... |
| "Heart attack," "myocardial infarction," "severe chest pain" |
Some programs can recognize MedDRA vocabulary and use thesaurus -like functionality to automatically match terms in reports from physicians to a pre-determined, approved company vocabulary. |
| MedWatch forms, individual case safety reports |
Some applications send the "spontaneous," "expedited," or "periodic" reports to the FDA on paper, CD-ROM, or electronically. In some cases, special EDI software from firms such as Cyclone or Templar must be installed. E2B format is key. |
| 7 reports of myeloma in Peoria linked to a particular medication |
Software can extrapolate incidence, severity of a safety issue based on artificial intelligence algorithms, other mathematical tools. May also use databases to find drug- and prescription-related data nationally or globally. |
| "My pills were wet, not dry, and now I'm feeling blue." |
If a patient has both a product-related report — mold on the medication — and an illness-related report, some tools can split the incident into two, tracking the manufacturing and clinical issues separately. |
| My report is due when? Are we selling this in Bulgaria? |
With overlapping international jurisdictions, and multiple formulations of the same drug, it can be tricky to know which data must be sent to which authorities in which countries. Some vendors support Japanese characters. |
| Integration with EDC, CDMS, CTMS, other systems |
All safety vendors can work with paper or electronic data but prefer electronic. Reconciliation with the original electronic data for the case is necessary. Some EDC vendors connect with safety systems. |
| SOURCE: BIO·IT WORLD |
Back to Safety at Last?
Software Helps Doping Control Lab Streamline Results Management The Karolinska University Hospital’s Doping Control Lab tests thousands of samples annually for stimulants, diuretics, and other masking agents. Increased regulatory pressure and new technologies increased the number of samples analyzed creating data management challenges. Waters® NuGenesis® Scientific Data Management System and TargetLynx™ Application Manager software were used to reduce the time required to calculate, review and search results.
Managed Innovation, Assured Compliance Discovery organizations are identifying a lot of promising compounds, but clinical research processes haven't kept pace with timely testing of all those potential therapies. This white paper describes how SAS® Drug Development supports true innovation across the clinical trial process.
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Medidata Solutions
Rising Clinical Trial Delays and Costs - Addressing the Cause, Not the Symptoms
 Protocol complexity is taking a toll on clinical study speed and efficiency: increasingly complicated and ambitious protocols are not only burdening sites and study volunteers but are also prolonging trials and increasing expenses. In response, sponsors have turned to global study placement, restructured site relationships and new site management practices, but the problem remains.
This podcast will discuss:
- Why these responses address only the symptoms, not the underlying cause, of rising clinical trial delays and costs.
- Results of a recent joint Tufts University / Medidata Solutions study.
- New metrics benchmarking protocol design trends.
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Speakers: Ken Getz, Senior Research Fellow at the Tufts Center for the Study of Drug Development, and Ed Seguine, General Manager, Trial Planning Solutions at Medidata.
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Director, Center For Information Technology (CIT) - National Institutes of Health (NIH), Department of Health and Human Service
Located in Bethesda, MD. This position requires:
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A TOP SECRET security clearance will be required. More job detail is found at: http://www.jobs.nih.gov under the Executive Jobs section.Or contact Ms.Winnie Garner at seniorre@od.nih.gov. Applications must be received ELECTRONICALLY by (11:59 p.m.), December 17, 2008. DHHS and NIH are Equal Opportunity Employers Bioinformatics Manager- Lilly Singapore Centre for Drug Discovery
For more information click here
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