White Papers

1. Governing And Maintaining Standards For Collecting Clinical Data 4/20/2021

   Clinical data standards can speed study build processes and drive higher quality data entry at sites. But often, these initiatives fizzle out. It’s possible to successfully establish standards if you involve the right stakeholders, stick to what’s necessary to support study objectives, and determine when and how updates should occur. Read this guide to learn how to establish and maintain a successful standards program to improve the efficiency and quality of your clinical processes.

2. How EDC Can Better Support Oncology Studies 4/20/2021

   Read how data managers at oncology-focused organizations are shortening database build times and supporting complex study designs (adaptive, branching, dynamic, basket) with a modern EDC.

3. Developing Your Mobile Sensor Strategy Journey For Better Study Outcomes 4/15/2021

   Several key factors have accelerated the uptake of digital health technologies (DHTs) in clinical trials, including an increased market demand in general for digital technologies, the COVID-19 pandemic, and increased acceptance of DHTs by regulators. Given the aggressive growth of DHTs (which can include any connected health device) in clinical trials, coupled with an increasingly large selection of possible devices, this white paper highlights key factors that should be taken into consideration as Sponsors and CROs develop their DHT strategy.

4. Drug Repurposing Trends And Strategic Approaches For Shortening Timelines 4/15/2021

   As the complexity of drug development increases, so does the industry’s focus on strategies and solutions that can help bring advanced products to market as quickly as possible.

5. Avoid Critical Findings In Your TMF - A Review Of MHRA Findings 4/14/2021

   In clinical research, there is great emphasis on the TMF being inspection-ready at all times. However, regulatory agencies still encounter critical findings in the TMF during inspection. The MHRA recently published their annual GCP Inspections Metrics Report covering metrics from April 1, 2018, to March 31, 2019, which include what issues were found during inspections. In this white paper, we take a look at the most common TMF issues and how to avoid them.

6. COVID-19 Vaccine Development: Building On A Legacy Of Innovation 3/31/2021

   The SARS-CoV-2 virus at the center of the COVID-19 pandemic may be novel, but the coordinated research and development efforts to create a vaccine for it are not entirely so. They borrow from experiences derived from more than 50 years of successful vaccine development programs. Read Worldwide’s take on the history of medicine and the development of the coronavirus vaccine.

7. Opiod Sparing: Prescribing Less Is Insufficient 3/31/2021

   Chronic and acute physical pain often requires treatment with strong analgesics. A treatment with opioid-sparing benefits could help mitigate the risks associated with opioids in one or more ways. This white paper analyzes how opioid-sparing benefits could help mitigate the risks associated with opioids, and argues that the opioid-sparing therapy must not diminish the level of analgesia obtained.

8. Virtualizing Clinical Trial Oversight: The COVID-19 Effect 3/29/2021

   The COVID-19 pandemic forced sites, sponsors, and clinical research organizations (CROs) to adopt remote and risk-based approaches for clinical trial execution to ensure the safety of trial participants, maintain compliance with good clinical practice, and minimize risks to trial integrity. If the benefits of this shift are to last, the industry must fully embrace and implement risk-based quality management approaches to trial virtualization strategies. This paper outlines the current state of RBQM approaches to virtualizing clinical oversight, and the value that adopting these approaches brings to sponsors, CROs, sites, and ultimately patients.

9. Artificial Intelligence Can Boost Reliability And Speed Of Medical Imaging Analysis In Clinical Trials 3/29/2021

   Pharmaceutical firms face many challenges in bringing their products through clinical trials — from enrollment delays to data quality issues — and every advantage can make a difference. In image analysis, sponsors can gain a critical advantage by leveraging artificial intelligence (AI) or machine learning (ML) — computer solutions that mimic human intelligence and are continually enhanced and updated to become more accurate as they take in more data.

10. China Embraces Decentralized Clinical Trial Solutions 3/29/2021

    The biopharmaceutical industry in China, like the rest of the world, was forced to swiftly adopt decentralized clinical trial (DCT) approaches to maintain progress during to the COVID-19 pandemic. And, like the rest of the world, its patients, investigators and sponsors were hopeful about the benefits of using these tools. Surveys show patients, sponsors and CROs in China see the benefits of virtual and hybrid trials. Concerns remain around regulatory gaps, digital data collection and study logistics.