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Clinical Research: Phase 1 - Phase 4

The Top 4 Problems Facing Clinical Research Project Managers (And Their Solutions)

Dealing with difficult situations is part of the job for project managers in any field, but clinical project managers (CPMs) must overcome a number of unique obstacles on the way to successful study completion. Read on for some of the biggest issues facing project managers today, as well as a few practical strategies for resolving...

Clinical Research: Phase 1 - Phase 4

The Top 7 Considerations to Take When Designing Pediatric Analgesia Trials

Children aren’t little adults: Pediatric populations have needs and physiological factors that set them apart from adults. However, it’s taken time for that philosophy to catch on within the clinical research community at large. When writing protocols for trials of acute pain in pediatric populations, researchers must take these unique needs of children into account to meet regulatory...

Clinical Research: Phase 1 - Phase 4

Applying Sound Research Practices in the Development of Medical Devices

Medical device and diagnostic companies face greater demand to provide clinical evidence of product efficacy than ever before. With increased scrutiny from regulators, healthcare systems, and even patients, more device companies are performing clinical trials to improve the likelihood of commercial success. In today’s competitive landscape, device companies are facing increased demand for clinical evidence...

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Designed Especially For Kids

Children are not little adults, and protocols for pediatric pain studies must take into account the unique needs of children to meet regulatory and ethical standards and protect this vulnerable population from untreated pain. Sponsors of pediatric analgesia clinical trials are tasked with designing studies that are both realistic to execute and sufficiently rigorous to...

Clinical Research: Phase 1 - Phase 4

Maximizing Success in Early Stage Oncology Trials

The success rate of investigational compounds eventually approved for clinical use in cancer remains the lowest among all diseases. Of the more than 750 drugs currently under development for the treatment of cancer, it is predicted based on past performance that only a few will ultimately demonstrate sufficient efficacy and safety for regulatory approval and...

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Involving Children, Adolescents, and Parents in Pediatric Drug Development

Actively seeking the involvement of pediatric patients and their parents throughout the life cycle of a clinical trial can help drive recruitment, retention, patient satisfaction, and, ultimately, the success of the study. Involving children in clinical research has long been a sensitive topic associated with several ethical dilemmas and operational challenges. There is now a...

Clinical Research: Phase 1 - Phase 4

The Science and Art of Conducting Clinical Trial Feasibility in Rare Disease and Pediatric Studies

Rare disease and pediatric studies present significant challenges, including country selection, site selection, and patient recruitment. A thoughtfully-designed, well-executed feasibility study can help sponsors obtain a realistic assessment of the best path forward for developing and conducting successful global clinical trials. Performing a thorough assessment of clinical trial feasibility is an important early step in...

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Navigating Expedited Regulatory Pathways in the U.S. and Europe

Breakthrough therapy designation in the U.S. and PRIority MEdicines (PRIME) in the EU are two programs intended to facilitate and expedite development and review of new drugs to address unmet medical needs. By successfully engaging with regulatory authorities early in the clinical development process, sponsors of eligible investigational drugs can help ensure that their development...

Clinical Research: Phase 1 - Phase 4

Clinical Trials in Rare Diseases: Every Patient Counts

In many rare and ultra-rare disease studies, sponsors do not have the luxury of choosing the countries or sites where the study will be conducted. Instead, they must use the sites where those patients are already being treated, regardless of geography. Additional protocol criteria – such as treatment-naïve patients or general prevalence of a disease...

Clinical Research: Phase 1 - Phase 4

Proven Strategies for Rare Disease and Orphan Drug Development in the U.S.

Orphan drugs are medicinal products intended to treat diseases so rare that sponsors are reluctant to develop them under usual marketing conditions. Orphan drugs are a growing market, due in large part to tax incentives, longer periods of market exclusivity, and shorter, smaller clinical trials, as well as the premium pricing associated with many orphan...