TranSenda now BioClinica With its innovative Office-Smart™ clinical trial software, TranSenda empowers clinical knowledge workers by sharing clinical trial operational data with SharePoint and Microsoft Office to create the most efficient...
Office-Smart Clinical Trial Manager
Leverage the Microsoft Office System to save thousands of hours per study
For clinical trial professionals who want their study software to work with their...
Henry Schein Medical Systems/ MicroMD On the strength of more than 25 years of innovation, the MicroMD family of solutions has grown to serve 13,500 physicians in primary care as well as all major medical and surgical specialties. The MicroMD name is now part...
Accumedic Accumedic Computer Systems, Inc. is an industry leading Technology Company that provides world class solutions and services to a wide array of healthcare professionals and medical institutions.
For three decades...
RNA Health Information Systems Pharmacy management software from RNA helps you attract and keep facility customers by improving the efficiencies and value-added services of your independent pharmacy. The Helix Pharmacy System equips you to fill orders...
Winchester Business Systems Founded in 1989, Winchester Business Systems, Inc. is a leader in providing software business solutions primarily to the pharmaceutical, biopharmaceutical, and medical device industries worldwide. These software solutions...
DataTrial Datatrial Limited was founded in 1999 by an investigator and entrepreneur, who saw firsthand the need for electronic data capture capabilities designed with the investigative site user in mind. By 2001, Datatrial had...
Cimcon Software, Inc. CIMCON Software, Inc. (CSI) provides a wide range of software solutions and compliance services that reduce costs and improve operational efficiency while complying with 21 CFR Part 11 and GxPs. CSI anticipates, defines,...
eInfotree
The industry's first and only available solution that provides 21 CFR Part 11 compliance for Excel spreadsheets, Databases and Files/Documents in a single...
Before an organization determines if they will integrate new technologies and guidelines into their existing internal business processes, they must understand the overall landscape of what will be impacted. For example, if an organization develops their own drug compounds, the process of taking those compounds to market is expensive (approximately $800 million) and time-consuming (minimum 12 ...
Medical Device Manufacturers have always focused on bringing innovative high quality products to market. Yet shifting financial, regulatory and globalization landscapes call for closed-loop product management strategies that can keep up with the increasing innovation tempo and complexity of medical devices while at the same time, lower cost, increase quality, and facilitate compliance with ...
The cost of developing new drugs has been increasing at an alarming rate – approximately 11 percent per year compared with annual drug sales growth of only 6 to 8 percent. At the same time, drug pipelines have been shrinking, putting even more pressure on biopharmaceutical companies to squeeze more out of what they have. Given the serious concerns over the spiraling cost of prescription drugs, ...
iLAB, an acronym for “integrated laboratory”, is a term that describes a new type of laboratory informatics system - a total laboratory automation system.
Understanding the value of an iLAB starts with an understanding of 4 key problems with today’s informatics systems.
1. No ‘Real-Time’ Control of Users: On a daily basis analysts are required to follow SOPs, but there is no way to enforce the ...
StudyManager enables Northeast Arkansas Clinic to conduct 120 clinical trials simultaneously while tracking what it’s being paid, what it’s owed by clinical study sponsors, and how profitable its clinical trial work is.
The 21 CFR Part 11 rule states that the FDA view is that the risks of falsification, misinterpretation, and change (without leaving evidence) within the GMP environment are higher with electronic records than paper records, and therefore specific controls are required.
The Veriteq validatable data logging system is a “hybrid” system that employs the use of both electronic records and signed ...
The 21 CFR Part 11 rule states that the FDA view is that the risks of falsification, misinterpretation, and change (without leaving evidence) within the GMP environment are higher with electronic records than paper records, and therefore specific controls are required.
The Veriteq validatable data logging system is a “hybrid” system that employs the use of both electronic records and signed ...
The FDA rule relating to the use of Electronic Records and Electronic Signatures (21 CFR Part 11) is one of the most significant pieces of new legislation to affect the pharmaceutical manufacturing industry in recent times.
With ever greater use of information technology and computer systems at all stages of manufacture, more and more of the operating processes are being automated. As a result, ...
At a time when biopharmaceutical sponsors are feeling intense pressure to increase R&D output, accelerate clinical timelines and reduce development costs, a growing number are moving away from paper-based processes and adopting electronic data capture (EDC). Sponsors are making this choice because once implemented, EDC brings efficiencies to the collection, exchange, analysis, and management of ...
Pharmaceutical manufacturing executives today are all too familiar with industry regulations such as Title 21 CFR Part 11 and current good manufacturing practices (cGMPs). However, many drug companies still struggle to comply with these and other U.S. Food and Drug Administration (FDA) requirements.
In 2008 alone, the FDA issued 43 warning letters to pharmaceutical companies for regulatory ...
StudyManager Reveal offers groundbreaking ease-of-use, power, and flexibility. Combining the latest web technology with 15 years of customer feedback, ...
StudyManager Sponsor Edition (SE) dramatically improves study performance with real-time interaction and clinical data collection for pharmaceutical and ...
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