FEATURED CONTENT

• Now In Effect: 3 Key Functions Your eTMF Needs To Meet New EMA Regulations

  In this article, consider three key functions that an eTMF must have to achieve compliance and maintain organizational success.

• Patient Voice Impacts Treatment Experience

  Download this guide for 5 key recommendations on how to build an eCOA strategy in your next oncology trial that keeps your patient's voice front and center in their care.

• Accelerating Study Start Up Through An Electronic Clinical Outcome Assessment (eCOA) Library

  Dive into how the shift to patient reported outcomes has made Clinical Outcome Assessments (COAs) an increasingly necessary and often required tool in the clinical research landscape.

• Ensuring Your BYOD Strategy Meets The Rigor Of Regulators

  Once sponsors add eCOAs in DCTs and hybrid trials, a common question emerges: Can patients reliably complete eCOAs on their personal devices?

• eCOA Predictions For 2022

  Dive into the prediction that the rapid adoption of eCOAs will continue to grow in 2022, as sponsors acknowledge how useful these tools have become in decentralized clinical trial (DCT) settings.

• Considerations For Implementing The Best eCOAs In Your Trial Design

  Dive into considerations when deciding on the best COAs to implement as well as best practices when developing your eCOA strategy in this blog.

• Real World Data In Real Time

  Learn how the benefits of real time insight can help sponsors create safer trials, while providing financial and strategic benefits that may give them an edge in the marketplace.

• BYOD Goes Mainstream

  Explore how COVID-19 opened the door for patients to use their own personal devices to record trial data and gave sponsors the nudge they needed to support a BYOD (bring your own device) approach to data collection.

• Disrupting The Traditional Approach To UAT

  By doing UAT in real time, discover how this ensures full alignment of the functionality and design within a clinical trial assessment.

• So You Want Your Trial To Be More Patient-Centric? Here's Why An eCOA Is Best For That

  eCOAs transform the paper-based assessment into a real-time digital tool that collects insights directly from the patient about their disease, the trial experience, and the treatment’s impact on their quality of life. Learn why this brings several immediate benefits.

• Beyond The Pandemic: Why eCOAs Are Here To Stay

  The permanent adoption of eCOA is a natural step in the industry-wide effort to create a more patient-centric clinical trial experience. Learn more in the available blog.

• Reducing Risks And Accelerating Study Startup Through An eCOA Library

  Find out how the shift towards a more patient-centric drug development landscape has made Clinical Outcome Assessments (COAs) an increasingly necessary and often required tool to gather patient experience data in most trials today.

• Fighting COVID-19 Like A Pro

  Explore how the use of electronic Clinical Outcomes Assessments (eCOAs) can be rapidly implemented to capture patient reported outcomes (PROs).

• Going Global With eConsent

  Scott Askin paints the picture of why Novartis, determined to improve the patient experience, has begun to deploy eConsent, and what they’ve learned along the way.

• Protocol Amendments And Electronic Consent: Overcoming The Challenges To Reap The Benefits

  Learn about some insights that have been gleaned from experience deploying eConsent on diverse trial types around the world.

• How An AI/ML Data Strategy For Life Sciences Can Deliver Better Business Outcomes

  Explore how data science and artificial intelligence / machine learning (AI/ML) driven predictive and prescriptive insights can help research teams cut the time and cost.

• Artificial Intelligence And New Technology Adoption In Risk-Based Quality Management

  Risk-Based Quality Management (RBQM) has been evolving into a mainstream choice for the critical monitoring aspect of clinical trials. Discover this evolution in the available white paper.

• Technology And Clinical Monitoring

  Clinical trials are evolving due to multiple forces that are affecting what was once a very standard approach. This notion of change has been constantly streaming into monitoring processes and the clinical monitoring role.

• Intelligent IRT Design Process Accelerates Digital Enablement At Sites

  In this case study, learn about the challenges and solutions biopharmaceutical industry sponsors worked through to digitally enable sites and speed time to first-patient-in for COVID-19 therapeutic and vaccine trials.

• Intelligent IRT Design Process For COVID-19 Trials Accelerates Digital Enablement At Sites

  Cenduit IRT study design teams took on the challenges pressing biopharmaceutical industry sponsors as they worked to digitally enable sites and speed time to first-patient-in for COVID-19 therapeutic and vaccine trials.

• Investigator Payments – A Critical Component In Bayer’s Sponsor Of Choice Strategy

  Year after year, slow and unpredictable investigator payments continue to be a top complaint from clinical study sites. Explore Bayer's Automated Site Payment Invoice Resolution project in the available white paper.

• Alnylam Puts Sites And Patients First With IQVIA Technologies Investigator Site Portal

  When Alnylam Pharmaceuticals began development of medicines for rare diseases with few or no treatment options, the company’s leaders knew they needed to design clinical trials that kept patient well-being and disease burden at the forefront. As Alnylam’s first clinical program began in 2014, the study team saw emerging site-facing technologies as a foundation for those trusted relationships, starting with a purpose-built communication channel and easy-to-use study conduct tools to support a complex protocol.

• The Case For Patient Diversity In Clinical Trials

  Two of America’s greatest assets are its diverse demographics and its relentless pursuit of new medicines and treatments. Unfortunately, it’s a widely known challenge that the two do not go hand in hand. Understand why minority participation in clinical trials is staggeringly deficient in this case study.

• Global Pharma Company Dramatically Improves Collaboration, Communication, And Compliance In Trials

  A Top 5 global pharmaceutical company wanted to help sites do everyday tasks more efficiently, making it easier for site staff to adhere to the protocol and deliver high-quality data. After evaluations and pilots, the company deployed IQVIA Technologies’ Investigator Site Portal (formerly DrugDev) in a 4-phase approach that delivered benefits each step of the way.

• How Technology And Relationships Can Improve Feasibility

  Conducting feasibility is an essential and necessary step to starting up a clinical trial. The good news is that the whole approach has the ability to change for the better by initiating and adopting some enhancements.

• Best Practices For Site Communications During COVID-19

  With so much new and updated information being shared on nearly a daily basis, it’s important to consider the most effective methods of organization and distribution. Here are some best practices we’ve compiled from working with sponsors and sites of all sizes and specialties during the COVID-19 pandemic.