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White Papers

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...

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Clinical Research: Phase 1 - Phase 4

Addressing the Challenges and Opportunities in Gynecologic Cancer Research

Gynecologic cancers continue to be a significant cause of female morbidities and mortality worldwide. Significant unmet needs exist in diagnosis and treatment. These cancers are often detected at later stages when therapeutic options are limited, and advanced or recurrent disease leads to a poor prognosis. Earlier diagnosis and more effective treatments will enhance the quality...

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Clinical Research: Phase 1 - Phase 4

Improving Birth Control for All: Opportunities and Obstacles in Male Contraception

Introduction There are currently more than a dozen categories of female birth control with proven efficacy on the market. For men, the only options available today are condoms and vasectomy. Despite decades of research and discussion about male contraception, no new products have entered the market since the condom was created in the 1800s. As...

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Clinical Research: Phase 1 - Phase 4

Ten Tips for Establishing the Clinical Utility of Molecular Diagnostics: Stepping Stones to Precision Medicine

Introduction The strongest foundation for successful widespread marketing of any diagnostic is evidence of clinical utility. Clinical validation – determining a test’s ability to diagnose a health condition or predict risk of clinical outcomes – may fail to convince physicians and especially healthcare payers to accept a new diagnostic. Failure to gain payer acceptance may...

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Clinical Research: Phase 1 - Phase 4

Opportunities Beyond Hope: Immuno-Oncology Drug Development

Introduction Over the past decade, immuno-oncology (IO) has become one of the most promising and fastest-growing areas of cancer research and drug development. Present-day advances in immuno-oncology can be attributed to an explosion of research in this area in recent years, leading to a paradigm shift in the understanding of cancer. Until the late 1990s...

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Clinical Research: Phase 1 - Phase 4

Women-Centric Approach to Clinical Trials

Introduction For decades, women were left out of clinical trials, despite the fact that they often process drugs differently than men due to their size, biology, and physiology. It wasn’t until 1993 that the NIH Revitalization Act mandated women and minorities be included in clinical trials funded by the federal government. This has resulted in...

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Clinical Research: Phase 1 - Phase 4

Phase 1 Trials: Strategies for Site Selection and Dose-Escalation

Introduction Designing and executing an effective Phase 1 trial for a novel investigational oncology product can be challenging. Every facet of the process, from site selection and recruitment rate analysis to trial design and start-up, is interconnected. A nuanced approach is important, and early, careful planning is critical. This white paper explores key considerations for...

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Clinical Research: Phase 1 - Phase 4

Gene Therapy for Parkinson’s Disease: Strategies and Operational Requirements

Introduction Gene therapy holds great promise as a potential treatment for Parkinson’s disease, a disorder for which currently available medications do not causally treat the underlying disease mechanisms. However, given the early stage of gene therapy research in this therapeutic area, questions abound regarding its utility and practicality in treating Parkinson’s disease. Those questions have...

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Consulting

The Changing Landscape of Psoriasis Treatment

Over the past two decades, biologic therapies have revolutionized the treatment of psoriasis, with more than half of treated patients now able to achieve essentially complete clearing of their disease. In this white paper, we will explore the history of psoriasis treatment – including topical and oral therapies – and the evolution of biologics. Psoriasis...

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Consulting

Medical Device Development: Pathways to Clearance or Approval in the U.S. and Europe

Introduction Although medical device development is similar in many ways to drug development, devices are subject to different regulatory requirements and approval pathways than drugs. There are also key differences in the rules for the clinical investigations needed to support marketing approval, in part due to the durable nature of devices, which may be implanted...

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