Maria Fardis, CEO of Iovance Biotherapeutics, has spent 18 years working in the pharma industry. Although most of her experience has been in small molecules and proteins, she now works in the cell therapy space and notes these treatments are a new and exciting space with meaningful differences in how clinical trials are conducted.
As a sea change has occurred over the last several years embracing patients as key stakeholders critical to clinical trial success, patient advocates who are knowledgeable about research have been increasingly sought after. Questions have been lightheartedly raised about how we “clone” the patient stakeholders who’ve made impact in the clinical trials enterprise (CTE) to date or create educational programs for the next generation of patients who express interest in getting involved.
The recent announcement that the watchdog group Center for Responsible Science (CRS) has filed a lawsuit against the FDA has raised some concerns in the clinical research community. The lawsuit is regarding the denial of the group’s citizen petition, which was originally submitted in June 2014.
The biosimilars market is going to heat up considerably over the next three years, but is the NHS ready for the biosimilars boom?
In the first annual Patient Adherence Influence Report, Adheris Health and inVentiv Health Consulting set out to understand the most influential factors driving patient adherence or non-adherence and to answer the question: Will the patient cross the finish line at the retail pharmacy, or will he or she walk away?
This white paper represents a compilation of industry best practices for designing, implementing and leveraging randomization and trial supply management (RTSM) software in clinical trials.
Read how utilizing electronic data capture systems ─ including eCOA ─ and training site raters, subjects and caregivers are important tools to ensure high quality data capture in rare disease research.
A discussion of the commonly encountered hurdles in studying rare diseases and how a cohesive and holistic approach can mitigate issues and help bring new treatments to patients.
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The TransPerfect Life Sciences Trial Interactive team was excited to attend the 2017 TMF Summit in London this October, where discussions on the movement from paper to eTMF continued to be a focus.
How the right technology can dramatically improve compliance, efficiency, and visibility in trials involving imaging.
What clinical researchers should consider as they start to make the essential pivot toward electronic data capture.
Understanding the integration challenges and technical demands of implementing electronic data capture (EDC) solutions.
Understand how Metrics provide the foundation for business intelligence for clinical trials, measuring success or failure.