Recently added articles from Applied Clinical Trials:
eVolve to the Paperless Way
Sep 01, 2008; ... Moving to the eWay of doing businessin any industryinvolves a little bit of pain, but it can also mean a lot of progress. Making the way to a paperless office is a shift of mind in any industry. Whether a "forced" migration onto a new software platform that requires less paper ...
Letters to the Editor
Sep 01, 2008; ... Global Clinical Trial Insight from TTC The increasing cost of drug development is a major concern for most pharmaceutical companies, including clinical grant spending in both established and emerging markets. The decision to include a specific country in a global clinical trial ...
Next Generation Site Selection?
Sep 01, 2008; ... Health Market Science (King of Prussia, PA) is offering a new data-driven approach to site selection for clinical trials. With nine years experience under its belt with its physician masterfile and claims data, Health Market Science has integrated both datasets along with clinical trials detail ...
At Home Testing Offers Solution
Sep 01, 2008; ... Subject recruitment and compliance remain a daunting necessity of the clinical trial process, often requiring sponsors to spend excess amounts of time and resources. Presently, companies designed specifically to address such issues that provide in-home and alternate-site health care ...
Taking Your John Hancock Digital
Sep 01, 2008; ... With the transition from paper to electronic comes the switch from pens to digital signatures. If s par for the course. But electronic signatures are not new. They've been around for some time. Can you even recall the days when UPS drivers carried around a clipboard and pen? The technology has ...
Foreign CROs Break Into U.S. Market
Sep 01, 2008; ... The prevalence of outsourcing within the clinical trial industry shows no sign of yielding, while globalization remains an influential phenomenon within the marketplace. When these growing trends encountered each other, U.S. sponsors and foreign CROs began to seek out the other's business at an ...
eShowcase
Sep 01, 2008; ... Send your new product info to: Kerri Nelen, knelen@advanstar.com Signal Detection and Management Software New release updates suite of pharmacovigilance and risk management Phase Forward (Waltham, MA) announced it has upgraded and renamed its flagship signal detection and ...
Global Trials Draw Regulatory Scrutiny
Sep 01, 2008; ... FDA is conducting more inspections to ensure that foreign clinical research meets GCP standards. The global expansion of pharmaceutical production ft and clinical research has put pressure on the FDA to step up its oversight of foreign drug development and production. The scandal over ...
EU Scorecard on Medicines for Children
Sep 01, 2008; ... Keeping score of Europe's one-year-old initiative to promote research for the pediatric community. In its first full year of operation, the work of the new pédiatrie medicines committee at the European Medicines Agency (EMEA) in London has led to the formal approval of only 15 pédiatrie ...
Getting to the Heart of Public Distrust
Sep 01, 2008; ... The public considers clinical research important, but they're not fans of the people behind it. National and international public opinion poils document that public confidence and trust in the clinical research enterprise has eroded steadily during the past decade. But despite widely ...
From Paper to Electronic the FDA Way
Sep 01, 2008; ... A perspective on the agency's updated guidance on the use of computer systems in clinical research. The U.S. FDA has recently released an update to their April 1999 Guidance, Computerized Systems Used in Clinical Trials.1 This new Guidance, Computerized Systems Used in Clinical ...
The Ins and Outs of Electronic Medical Records
Sep 01, 2008; ... Shedding light on common EMR concerns about privacy, government regulations, and data integrity. Electronic mEdical records (EMRs) have been considered a panacea for cutting down on medical errors, streamlining recordkeeping, and delivering quality care to patients by health care ...
Breaking Barriers to Enterprise Content Management
Sep 01, 2008; ... True efficiency requires the move to a company-wide ECM solution that supports the entire content lifecycle. Over the past 10 years, the life sciences industry has faced the twin forces of fierce competition and ever increasing regulatory pressures. To get products to market faster and ...
Simulated Strategies for Better Trials
Sep 01, 2008; ... The use of computer simulation models to improve both site selection and subject recruitment. Getting patients and doctors into clinical trials has become the most delay ridden aspect of the drug discovery and development process over the past 10 years. Patient and investigator ...
BUSINESS AND PEOPLE UPDATE
Sep 01, 2008; ... People * Alison Taber has joined Copernicus Group IRB (Research Triangle Park, NC) as the company's new chief operating officer. * Kenneth G. Faulkner is the new vice president of Medical Imaging at Perceptive Informatics (Waltham, MA), the technology subsidiary of Parexel ...
A Revised Approach to Early Trials
Sep 01, 2008; ... Companies with the fastest time to market are also the most likely to stop development early. Considerable skill is required to identify failing compounds and the evidence is rarely clear cut. So the question arises: How many of these abandoned molecules would have demonstrated interesting ...
What You Want In These Pages
Aug 01, 2008; ... Our annual reader survey proves that you value us, you grapple with the challenges of our industry, and our content is on target. Each year Applied Clinical Trials conducts a reader assessment survey to evaluate how we are serving your needs. Some questions are the same each year, and ...
Letters to the Editor
Aug 01, 2008; ... Biotechs and CROs With interest I read "Outsourcing the Biotech Trial" by Frank Henke in June's Applied Clinical Trials. Although in my opinion there is no difference in a biotech trial or a big pharma trial, there is a clear difference in the outsourcing aspects, as very well described ...
Top 5 Peer-Review FAQs
Aug 01, 2008; ... The peer-review process for journals is well-known and used primarily in the medical and life sciences fields. The following FAQs are specific to Applied Clinical Trials magazine: Who are the peer-reviewers? Our Editorial Advisory Board provides peer-review for submitted articles ....
Adventures in Web-Based EDC
Aug 01, 2008; ... EDC continues to be a topic of discussion and exploration for many companies involved with clinical trials. While surveys of last year noted that EDC implementation had arrived, implying a static event, the truth is that EDC is an ongoing process of implementation, learning, changing, and ...