Clinical Research: Phase 1 - Phase 4

Clinical Research: Phase 1 - Phase 4

The Expanding Role of RWE in Rare Studies

4 August 2022 10:00am EST Real-world evidence is increasingly important in drug development as the medical and pharma communities recognize the data’s potential for predicting the benefits of treatment interventions. Accelerating this trend is the Food and Drug Administration’s growing understanding of how RWE has helped researchers better understand and use COVID-19 treatments. While placebo-controlled...

Clinical Research: Phase 1 - Phase 4

Addressing Challenges In Bringing Male Contraceptives to Market

21 July 2022 10:00am EST There are currently more than a dozen categories of female birth control with proven efficacy on the market. Conversely, the only options available for men today are condoms and vasectomy, despite decades of research. No new male contraceptive products have entered the market since the condom was created in the...

Clinical Research: Phase 1 - Phase 4

Full Service or FSP? How to Choose the Right Model for Your Study

Typically, when people talk about a full-service contract research organization (CRO) they mean a group that handles every aspect of a clinical study, supplying the personnel, the systems, and the processes. The sponsor is spared all operational involvement with the full-service model, simply receiving key information at specified intervals. This model works very well for...

Clinical Research: Phase 1 - Phase 4

7 Tips for Designing and Operationalizing Rare Disease Natural History Studies

Natural history studies play a crucial role in rare disease drug development, providing insights that advance discovery and shape clinical trial design. The benefits of these studies also extend to understanding patient journeys, clarifying the standard of care, identifying disease-specific centers of excellence, and surfacing opportunities to improve patient care. In this blog post, we...

Clinical Research: Phase 1 - Phase 4

How to Use Patient Registries and Natural History Studies in Rare Disease Development

Successful drug development requires a deep understanding of the disease of interest—its etiology, epidemiology, presentation, manifestations, and progression. In rare diseases, however, much of this information may be unknown. Patient populations are small and historical data are collected inconsistently and dispersed across treating physicians practicing in diverse geographies. Patient registries and natural history studies are...

Clinical Research: Phase 1 - Phase 4

Premier Research Named Partner of Choice

Premier Research has been cited in a Clinical Leader article as the CRO partner of choice for Daré Bioscience. The article, “How To Build A Strong CRO Partnership And Find Drug Development Success,” explores criteria to keep in mind when selecting the ideal CRO partner and how a positive sponsor-CRO partnership led to success in...

Clinical Research: Phase 1 - Phase 4

Natural History Studies: Understanding and Enhancing Their Value in Rare Diseases

Successful drug development requires a comprehensive understanding of the underlying disease. To design reliable clinical trials with meaningful, measurable outcome measures, sponsors must apply thorough knowledge of disease presentation, manifestations, and progression, which may be challenging in rare diseases where this information is minimal. Thus, observational studies, encompassing both registry and natural history studies, play...

Clinical Research: Phase 1 - Phase 4

IVDR Survival Guide: Understanding the IVDR Product Classification System and Complying with the New Clinical Evidence and Performance Expectations

The EU has been working to strengthen its regulations for better patient protection and more effective implementation of the rules for in vitro diagnostic medical devices. As a result, in May 2017, a five-year in vitro diagnostic regulation (IVDR) transition plan went into effect. While some of the dates have been extended1 to allow for...

Clinical Research: Phase 1 - Phase 4

Considerations for Clinical Studies in Contraception

Women today can choose from a wide range of effective and safe contraceptives based on their medical and lifestyle needs. Over the course of their lives, women may change contraceptive methods for a variety of reasons, such as concerns about side effects. For researchers, the objective of contraceptive development is to design products that offer...

Clinical Research: Phase 1 - Phase 4

5 Tips for Operationalizing Gene Therapy Studies

Gene therapy clinical trials are logistically complex studies that require highly qualified sites and engaged patients for success. The ability to select the right sites and patients can be the difference between product failure and market approval. In this final part of a three-part blog series on gene therapy development, we provide tips on operationalizing...