Clinical Guest Contributors

1. FDA Seeks Comment On Conducting Remote Regulatory Assessments 8/11/2022

   The FDA believes the use of both voluntary and mandatory remote regulatory assessments (RRAs) for all types of FDA-regulated products is in the interest of public health. The document describes the difference between voluntary and mandatory RRAs and shares information about the RRA report. Public comment ends on Sept. 30, 2022.

2. Pharma Companies Are Tapping Digital Health For Improved Patient Outcomes 8/11/2022

   Smarter diagnostic tools and a growing role for remote care will be of huge importance in the new paradigm. The pharma industry, which is already growing its role in delivering hybrid solutions combining therapies with diagnostic and smart solutions and devices, could play a significant role here.

3. Janssen’s 3 Strategies For Improving Clinical Trials In Neuroscience 8/9/2022

   Many of the critical challenges that clinical trials face involve recruitment obstacles, underscoring the need for researchers to modernize their approach to clinical trial design and patient identification. This article shares the three strategies Janssen is employing to address these challenges, particularly in the area of neuroscience.

4. The Methylation Analysis Landscape In 2022 8/8/2022

   Within liquid biopsy, methylation has become a key area of interest due to its role in altering gene expression and its ability to provide information on tissue-of-origin for ctDNA. The explosion of methylation as a biomarker in oncology stems from its ability to serve as an indication for the presence of cancer early in development. This article also shares key market insights about the diagnostic companies currently working in this area.

5. Your 3-Step Process For Innovation In Precision Medicine 8/3/2022

   Scientific advances are exciting, but not every discovery translates well into the clinic. Why is that? And how can companies successfully position themselves for market success with their drug discovery efforts? 

6. 4 Strategies For Sponsors To Tackle Clinical Trial Talent Shortages 8/2/2022

   In the first quarter of 2022, more than 50% of sites cited staffing as their top issue. This lack of personnel impacts all aspects of the clinical trial process. As a sponsor, creating a lasting solution calls for working together with your CRO and the site to overcome the hiring challenges. However, there are small measures you can take independently. This articles shares four key strategies.

7. Data: The Near Future Of Regulatory Info Management In Europe 7/29/2022

   Data, rather than static documents, is the future of regulatory information management. It also paves the way for information to be shared in different formats as use cases dictate, while still ensuring the consistency of the data. Even though regulators haven’t quite got their ducks in a row yet, they know full well that this is the scenario that everything is pointing toward. So, to prepare for anything less would be unwise.

8. How AI/ML Is Helping Clinical Researchers Investigate Alzheimer’s 7/28/2022

   Like many cognitive conditions, Alzheimer’s disease can cause changes to a person’s speech and language. Artificial intelligence (AI) and machine learning scientists are working on automating speech assessments to detect the disease earlier and improve understanding of the efficacy of novel treatments. 

9. 3 Key Factors For Selecting Clinical Data Providers 7/27/2022

   As the volume and availability of clinical data have increased, so has commercial interest in clinical data. The wide array of data-sharing initiatives makes it difficult for pharma companies to identify and select the right source or sources of data to deliver on their needs. Here are three key factors to consider as you select and engage with clinical data providers.

10. Your Guide To Harnessing Clinical Trial Sensor Data Better 7/26/2022

    Technological advances in wearables and sensors are speeding the development of digital measures and endpoints. This sensor data is often in native formats unique to each sensor technology and in proprietary clouds owned by the manufacturer. To address this challenge, the Digital Medicine Society released a set of open-access toolkits to support the successful scaling of sensor data to drive better clinical decisions.