Posted on 9/28/2016 2:48 PM
Releasing the details and results of clinical trials to the public has long been a critical ethical issue facing the pharmaceutical industry. How much information should be disclosed? How do companies developing new products protect sensitive details? What is our obligation to trial participants, the scientific community, and the world in general? Read more to find out...
Posted on 7/21/2016 12:00 PM
Clinical Document “Redaction” is a hot topic in our industry today, and I was able to see this first hand at the annual DIA meeting in Philadelphia. DIA (Drug Information Association) is the largest multidisciplinary forum for knowledge exchange that fosters innovation to raise the level of health and well-being worldwide....
Posted on 6/1/2016 10:08 AM
The day you stop learning is the day you stop growing. The ongoing pursuit of knowledge makes us not only more agile but also gives us the right tools and skill sets to evolve and enhance productivity. Nurturing the corporate values of "Strive for Good Science" & "Value Talent", MMS has always...
Posted on 4/22/2016 9:51 AM
MMS Case Study: Data Transparency & Anonymization Programming – Innovation at Work. Read about the challenge, solution, and outcome to see how MMS could help your team!
Posted on 4/5/2016 10:00 AM
In an effort to give back to our community, MMS colleagues worked with the American Red Cross to deliver water to our neighbors in Flint, Michigan. On Wednesday, March 9, the MMS team was able to deliver 190 cases of water and numerous water filters to over 140 homes. Many people may have heard of the situation in the Flint through media coverage, but it was a truly different experience being in the city and talking to the residents. The lead contamination has left residents without easy access to clean water. The residents need to use bottled water to not only consume and cook, but also to wash their faces and brush their teeth.
Posted on 3/1/2016 10:00 AM
Challenge: Small Pharma Requests Regulatory Writing Support for Anti-Infective Agent A small pharma company was seeking a Fast Track designation for their anti-infective agent to provide more frequent FDA interaction and a rolling review of program submissions. Also, as part of the Pediatric Research Equity Act, the anti-infective program was required to have a plan for pediatric studies prior to the NDA submission. They were in need of regulatory writing support for the submission documents,
Posted on 12/14/2015 10:00 AM
Both the Food and Drug Administration (FDA) and independent research groups have highlighted the lack of compliance with laws (2007 FDA Amendments Act) mandating that clinical trial data for approved products be disclosed to publicly accessed websites. Furthermore, findings of a study published in BMJ Open indicate that the clinical trial data disclosed by leading pharmaceutical companies is inconsistent both across trials and across companies. Contributing factors to the noted lack of complia
Posted on 12/8/2015 11:37 AM
Or rather “cures.” Cancer is a not a single disease, but rather a complex set of diseases that consists of various genetic mutations, protein overexpression or loss of protein expression/activity. Therefore, a number of different treatment options need to be available to address not only the type of cancer (breast, prostate, etc.), but also the biochemical characteristics of that particular cancer (eg, loss of PTEN expression, overexpression of HER2). Such commonalities in disease among patient