Clinical Operations Featured Articles

  1. SCDM Best Practices Now Available To Nonmembers 9/13/2016

    Data managers are critical to the clinical research process. It’s the data they collect which will ultimately determine whether a new drug gains FDA approval. Recognizing that, the Society for Clinical Data Management (SCDM) was established to work with the teams creating clinical trials, writing the protocols, and identifying the information that needs to be captured. Over the years, the information gathered by SCDM members has been incorporated into a guide book of Good Clinical Data Management Practices, which SCDM is now making available to nonmembers as well as association members.

  2. Israel's Emergence As A Go-To Market For Conducting Clinical Trials 9/1/2016

    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.

  3. Phase I Clinical Supply Landscape: Trends, Demarcation And Security 8/30/2016

    The core addressable early phase market is USD 11.9 billion growing with a CAGR of 2 – 3 percent. Early-phase trials are outsourced at greater than 60 percent by pharma, as the trials are costly and small in number. The supply market for early phase is comprised by CROs, research centers, and academic institutes. The market size that is comprised by the CROs is estimated to be around USD 8 billion, which is about 67 percent of the early phase market.

  4. Pharma And Physicians – The Key To Successful Clinical Trials 8/30/2016

    Traditionally in the pharmaceutical and biotech industry worlds, a pharma company develops a candidate product and then works with a group of doctors to test that product under careful standards and procedures—very much managed by the pharma company. If the product shows therapeutic value and safety, it becomes available to prescribers to administer to patients.

  5. mHealth Panel: Make Progress, Not Excuses 8/30/2016

    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?

  6. Clinical News Roundup: Bioclinica To Be Acquired By Cinven 8/26/2016

    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.

  7. Overcome The Increasing Complexity Of Clinical Logistics 8/24/2016

    Clinical trials have become more complex than ever. Although there is still some debate around exactly how complex they have become, trials today seem to have more endpoints, procedures, eligibility criteria, protocol amendments, and investigator sites than just 10 years ago. Add adaptive trials to the mix, and clinical supply executives have more to worry about than ever before. Perhaps it’s time to make your clinical supply chain as flexible as your trials.

  8. Clinical News Roundup: What To Expect From PDUFA VI 8/19/2016

    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.

  9. With RE-VECTO, BI Investigates Clinical Use Of PRAXBIND 8/18/2016

    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.

  10. Clinical News Roundup: Can Clinical Trials On Pets Help People? 8/12/2016

    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.