Articles By Ed Miseta

  1. Clinical Trials In APAC: Challenges And Opportunities 9/29/2022

    For several years, the APAC region has been one of the hottest growth regions for clinical trials. In June 2022, I had the opportunity to sit down with three experts on the region. They were able to discuss the growth of trials in the APAC region, the opportunities presented to sponsor companies, and the challenges that still exist.

  2. Top Site Complaints: Budgets, Communication, And Technology 9/27/2022

    Technology firm Greenphire conducts an annual survey to determine the trending issues that matter most to clinical sites. Last year the company asked me if there was a question that I would like to see included in their survey. I requested that Greenphire ask its survey takers about the one thing they would like sponsor companies to do for them. The sites responded.

  3. A New Pain Treatment Requires Accurate And Reliable Data 9/21/2022

    South Rampart Pharma aims to deliver a new, affordable treatment for pain that will avoid the issues with currently marketed products. Opioids are highly addictive; patients taking excessive amounts of acetaminophen can develop liver toxicity; and NSAID over-exposure risks kidney toxicity, gastrointestinal (GI) bleeding, and worsening of high blood pressure in patients with hypertension.

  4. Walgreens Is Ready To Re-Envision Recruitment, DCTs, And RWE 9/12/2022

    Since becoming CEO of Walgreens Boots Alliance (WBA) in March 2021, Rosalind Brewer has been focused on healthcare and what the company could do to help its patients. WBA refers to the integrated healthcare, pharmacy, and retail store that currently serves millions of customers and patients every day. This past June, the company launched its clinical trial business. 

  5. Digital Solutions, Technology, And Patient Care Top Life Science Trends 9/6/2022

    Technology company Within3 has produced a paper on the six top trends that are going to impact the pharmaceutical space. It’s no surprise that technology solutions were one of the trends making the list, but also included were factors such as patients, cyber threats, and a growing global marketplace.

  6. How Sanofi Created A Patient-Informed R&D Organization 9/1/2022

    Getting the patient voice embedded in drug discovery is a goal of many pharma companies. When Sanofi opted to tackle this challenge, it wanted the voice of patients to extend across the entire organization. That effort would mean embedding the patient experience, perspectives, and priorities in every step of the drug development process.   

  7. How Is The Role Of Clinical Data Manager Changing? 8/30/2022

    The results of a study are only as good as the data collected. For that reason, clinical data managers (CDMs) are often the unsung heroes of clinical trials. Those managers must ensure the collected data is accurate, while avoiding tainted data that can endanger patients, studies, and the reputations of the companies conducting the research.

  8. LLS is Working To Change The Pediatric Clinical Trial Model 8/11/2022

    In pediatric trials, answers do not come quickly. The trials are time consuming, and many sites are required. That means costly studies and an end market that is small. This leads pharma companies to adopt a business model that focuses on an indication that will help the most people. But that model also means children will always be at the end of the line.

  9. What Should You Do To Prepare For EU (536/2014)? 8/4/2022

    In May 2022, Clinical Leader hosted a webinar on the EU (536/2014) regulation and the impact it could have on drug developers hoping to conduct trials in the EU. This Q&A summarizes some of the questions addressed during the webinar.

  10. Sites And Patients Need Help – Here's What You Can Do 8/2/2022

    Ian Wyglendowski is passionate about being a better partner for patients, sites, and CROs. He is currently the head of strategic clinical partnering at UCB and is focused on partnering activities that will create better relationships between all stakeholders in the conduct of clinical trials.