04.05.21 -- Bayer Overhauls Its Clinical Trial Planning Process

Without an engaged patient, a clinical trial cannot do its essential work. It is also important that we remember that clinical trial participants are people; they aren’t just the data we collect. We put the patient experience at the center of clinical trial design.

Where a combination of traditional trial expertise, technologically savvy insightful dialogue with patients, and pragmatic processes are required to successfully execute a hybrid or virtual clinical trial.

Patient attrition has always been a challenge in clinical research, but the use of decentralized clinical trials (DCTs) may help sponsors overcome attrition problems. Learn what clinical trial models can bolster retention and greater engagement between patients, investigators, and sponsors.

By its nature, EU compassionate use supply is needed urgently. This means packaging, labeling, and distribution must be executed rapidly and efficiently. Trial sponsors must know what issues to manage and need to select the transportation routes carefully, especially during COVID-19. Industry experts describe the logistical and distribution risk management factors that need to be considered when planning an EU compassionate use program.

Driving a path forward for continuous manufacturing calls for a closer look at current global challenges, any existing barriers, and the ideas and initiatives necessary to fulfill its potential.

As life sciences companies grow, the regulatory compliance requirements, and risks, expand as well. These responsibilities extend beyond conventional health-related frameworks (e.g., GxP, HIPAA, etc.) into the realm of data privacy as well. For high-growth institutions with limited resources and bandwidth, the question arises: what should you do?

Read this white paper for perspectives from three parties — a sponsor, a site, and a technologist — to understand current challenges with information sharing and steps to improve collaboration in clinical trials.

Innovation in the area of oncology has taken off at a historic pace. Private industry and the FDA are relying more on Big Data, specifically multisource, point-of-care, real-world data (RWD), to power clinical and economic real-world evidence (RWE) outcomes. We are experiencing more powerful, streamlined ways to bring innovations and advances to patients who need them at the point of care.

Over the last several decades, several wearable heart rate (HR) monitoring devices have been developed with the intent of delivering automated, convenient, and continuous HR monitoring. A number of these technologies are wireless and based on photoplethysmography (PPG) signal assessment, which measures changes in blood volume in the microvascular tissue under the skin. Read more about the advantages of PPG and how it compares to ECG.

No clinical supply request could be a higher priority than that of a physician urgently seeking an investigational cancer drug for a patient who has exhausted all treatment options. 

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.

This e-book examines the use of electronic tools for maintaining regulatory compliance at research sites, and recommends best practices to be applied to the use of those tools.

Data Analytics Real-World Interrogation Network (DARWIN): the natural evolution of regulatory science in the EU and a turbocharged complement to RCT data.