Regulatory Affairs Editorial

  1. Israel’s Emergence As A Go-To Market For Conducting Clinical Trials

    Driven by the steep costs of hosting clinical trials in the United States and Western Europe, pharmaceutical companies have increasingly turned to global markets to conduct trials over the last decade. During that timeframe, Israel has emerged as an attractive market – bolstered by its high-quality medical infrastructure and well-trained physician workforce, diverse patient population and widespread adherence to Good Clinical Practice (GCP) standards.

  2. mHealth Panel: Make Progress, Not Excuses

    I recently moderated a couple panel discussions at the 2016 eyeforpharma Data Quality & Technology in Clinical Trials conference in Philadelphia. One of the panels was on the use of mobile and wearable technologies in clinical studies. While many sponsors continue to cite concerns over regulatory issues, other companies are moving forward with their adoption. But what are the main concerns companies face, and how can they be best overcome?

  3. Clinical News Roundup: Bioclinica To Be Acquired By Cinven

    Clinical news roundup for the week of August 22, 2016 with information on the Bioclinica acquisition by Cinven, SCRS Eagle Award finalists, supporting kids with brain tumors, reducing risk in adaptive trials, Zika testing in humans, and more.

  4. Clinical News Roundup: What To Expect From PDUFA VI

    Clinical news roundup for the week of August 15, 2016 with articles on the new PDUFA agreement, a super vaccine to guard against pneumococcal disease, the trends impacting clinical trials, the launch of VitalTrax, and new trial rules in India.

  5. With RE-VECTO, BI Investigates Clinical Use Of PRAXBIND

    Boehringer Ingelheim Pharmaceuticals has announced the launch of a global program designed to evaluate the use of its PRAXBIND medicine, which received FDA approval in October 2015. The program, titled RE-VECTO, will gather data to better understand the actual usage of PRAXBIND in clinical settings.

  6. New Patch Technology Will Help Scintilla Treat Pain

    Pain management company Scintilla Pharmaceuticals has announced it will acquire SCILEX Pharmaceuticals to bolster its pain management business. SCILEX is engaged in the development and commercialization of products focused on the treatment of pain. Its lead product candidate, ZTlido, is a branded lidocaine patch formulation being developed for the treatment of postherpetic neuralgia, the chronic pain that sometimes develops with shingles.

  7. Clinical News Roundup: Can Clinical Trials On Pets Help People?

    Clinical news roundup for the week of August 8, 2016 with articles on using pets in clinical trials, the Quintiles/DaVita alliance, the benefits and pitfalls of data sharing, and the Orphan Drug Act.

  8. How RBM Is Changing The Role Of Monitors

    Is risk-based monitoring (RBM) changing the role of monitors in clinical trials? In the latest issue of the Pharmaceutical Outsourcing Monitor, Michael Martorelli of Fairmount Partners takes a look at this issue, and features some interesting feedback from readers along with informative insights from Jim Kremidas of ACRP and Clara Heering of ICON. How is RBM changing the role of monitors and what do you need to know?

  9. J&J Takes The Lead In Clinical Data Transparency

    It’s a problem that clinical researchers have dealt with for years. A researcher has an idea for a study. They identify an existing data set, produced by other researchers, which would be ideal for that particular study. Although that data is not currently being used, the researcher is not able to access and use the clinical trial data because it is not being shared. This is a situation that Johnson & Johnson (J&J) is hoping to change.

  10. Clinical News Roundup: Is Failing Patients?

    Clinical news roundup for the week of July 25, 2016 with information on, patient empowerment, wearable technologies in clinical trials, clinical trial information, and India lagging in hepatitis research.