Data Management Featured Articles
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Finally Getting It Right: The Future Of Forecasting And Making Investigator Payments
11/14/2016
Here’s an odd contradiction: It’s difficult to overstate the importance of efficient and timely investigator site payments to successful execution of clinical drug trials. Yet contract researchers have done a consistently poor job managing the payment process, frustrating the people we count on to conduct our trials and putting the very outcome of those studies at risk.
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Clinical News Roundup: Artificial Intelligence Ready To Run Clinical Trials
11/11/2016
Clinical News Roundup for the week of November 7, 2016 with information on artificial intelligence running clinical trials, the UPS acquisition of Marken, efforts to track unpublished trial data, clinical success with the Zika virus, Takeda’s digital health efforts, and more.
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Lilly Makes It Easier For Physicians To Become Investigators
11/10/2016
As the global head of clinical innovation for Eli Lilly and Company, Katherine Vandebelt knows there are many things pharma needs to do better. No drug can make it to market without first navigating the clinical trials process, which creates a burden on the physicians involved. Therefore, it should come as no surprise to anyone involved in the process that many physicians will oversee one trial and then opt to no longer take part in them.
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SCRS: Site/Sponsor Relationship Needs Improvement
10/28/2016
At the 2016 SCRS (Society for Clinical Research Sites) Global Site Summit, Christine Pierre, president of SCRS, shared the results of a survey conducted of site professionals from around the world. The survey is conducted every year, just prior to the summit, to gauge the opinion of site professionals on various issues and trends. If the results are any indication, there is still room for improvement in sponsor/site relationships.
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PatientsLikeMe And Duke Bring Novel Approach To ALS Trial
10/26/2016
Can the peptide Lunasin help to reverse the debilitating effects of ALS? After one patient (and three experts) noted it could, PatientsLikeMe and the Duke ALS Clinic decided to get involved. Their novel trial will feature an unlimited number of patients, sharing of all patient data, and electronic patient reported outcomes. It also eliminated the use of a placebo.
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Clinical News Roundup: Sanofi Invests To Bring Clinical Trials Home
10/23/2016
Clinical news roundup for the week of October 21, 2016 with information on Sanofi and Science 37 bringing clinical trials to the home, SCRS Eagle Award winners, a precision master trial for AML, promoting trials to patients, stopping the progression of Alzheimer’s disease, and more.
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What Will Clinical Research Certification Mean To Pharma?
10/18/2016
The National Board of Medical Examiners (NBME) is a not-for-profit organization that has been around for over 100 years. Its primary mission is assessing the qualifications of healthcare professionals. More recently, the group has been looking into developing an assessment that would be helpful to clinical researchers.
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TransCelerate Seeks To Improve Clinical Trial Quality
10/12/2016
TransCelerate Biopharma is all about collaboration. The group’s goal is to identify, prioritize, design, and facilitate the implementation of solutions to help sponsors efficiently and effectively produce needed medicines for patients. In this interview Deb Driscoll, VP of quality assurance at Merck and lead of the TransCelerate QMS (quality management system), discusses how the initiative hopes to improve quality in clinical trials.
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Clinical News Roundup: Is 80 Percent Of China’s Clinical Data Fabricated?
9/30/2016
Radio Free Asia (RFA) is reporting that a government investigation in China has revealed fraudulent practice on a massive scale in clinical trials. China's food and drug regulator recently carried out a one-year review of clinical trials, concluding that more than 80 percent of clinical data is "fabricated," state media reported.
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Adaptive Trials: Complex But Advantageous
9/28/2016
When I speak with pharma executives on certain topics, it’s amazing to see the difference in where companies stand in terms of implementation. Adaptive trials is one of those topics. I will talk to one executive who will tell me it is one of the trends that will most impact the pharma industry in the coming year, and then talk to another who will tell me it’s old news and something they have been doing for years. Regardless of where you stand with adoption, one thing is clear: Adaptive trials have many advantages, but are also more complex.