Patient and Stakeholder Engagement

Medical and Regulatory Affairs

Clinical Data Trends: Transforming Data Access/Analysis

The clinical trial industry has been steadily undergoing a data evolution. Data from remote capture devices, such as wearables and other novel sources (e.g., increasingly large health data repositories and electronic healthcare data), have gained importance. Proper management and utilization of such data allows sponsors to untether from a set roster of trial sites, focus...

Medical and Regulatory Affairs

Long-Term Gene Therapy Follow-Up: Patient Considerations

When developing a long-term follow-up strategy for gene therapy trials, safety is the main concern, closely followed by the patient perspective. Digital technologies and monitoring have proven essential to this, easing the burden on the patient, and providing accurate, time-saving methods of data management. Momentum is increasing in the field of gene therapy, with over...

Patient and Stakeholder Engagement

“It Motivates Me Every Day”: Our Premier Research Team on Why Rare Disease Research Matters

There are as many as 7,000 distinct types of rare and genetic diseases, and an estimated 400 million people suffer from a rare disease globally. In addition, three of 10 children with a rare disease won’t live to see their fifth birthday. Rare Disease Day, celebrated around the world on the last day of February,...

Patient and Stakeholder Engagement

Essential Strategies for Patient-Focused Dermatology Clinical Trials

Dermatology clinical research is undergoing a rapid transformation in response to new demands for clinical trials that are more justifiable, safer, and less burdensome for patients. In dermatology, a patient-focused approach can be applied to all phases of the research process, from the earliest stages of discovery and pre-clinical testing to clinical trials, regulatory approval,...

Medical and Regulatory Affairs

Dermatology Webinar Series: Looking Ahead to the Future of Dermatology Research

New treatment options for moderate to severe dermatological diseases and areas of high unmet need are driving a revolution in clinical development of dermatology drugs. But questions remain: What indications should be pursued? How to design a study that targets the right endpoints? And how will environmental constraints affect the research? In this three-part series,...

Clinical Research: Phase 1 - Phase 4

The Importance of Site Selection and Dosing Strategies in Early-Phase Oncology Studies

TORONTO (PRWEB) NOVEMBER 02, 2020 Setting up an effective phase 1 trial for a novel investigational oncology product is rife with challenges. Every aspect, from site identification to estimation and coordination of enrollment and safety review, is interrelated to ensure a timely dose determination that is nimble and allows flexibility. What factors can affect, or...

Clinical Research: Phase 1 - Phase 4

Essential Strategies in Dermatology Clinical Trials: The Convergence of Patients, Regulations, and Study Design

Competition for patients among sponsors in the field of dermatology drug development has never been as intense as it is now — so much so that it’s becoming difficult to meet project timelines, attract and retain patients, and achieve comprehensive study results. Patients are in high demand, and making studies appealing to them — convenient,...

Clinical Research: Phase 1 - Phase 4

Operational & Regulatory Factors in Cross-Border Enrollment in Rare Disorders

Researchers are more focused than ever on finding treatments and cures for rare diseases, encouraged by a regulatory environment that is increasingly welcoming to innovation and collaboration. But even under these favorable conditions, the potential success of orphan drug development hinges on finding patients and getting them to trial sites. Patients for rare disease trials...

Clinical Research: Phase 1 - Phase 4

mHealth and Remote Clinical Trial Strategies to Include in Your Next Study, Upcoming Webinar

TORONTO, ONTARIO (PRWEB) OCTOBER 01, 2020 What happens when patients and clinical research associates alike can’t—or won’t — go to your clinical trial sites? It’s time for a new plan. In the months since the novel coronavirus brought all normal activity to a halt, clinical trials worldwide have been forced to re-examine their strategies and...