In rare disease research, every patient counts. Recruitment is challenging, retention even harder, and each data point is invaluable. Yet rigid trial protocols often create unnecessary barriers for patients, families, and sites alike. For rare conditions where participants are geographically...
Premier Research
Each year on September 17th, the World Health Organization recognizes World Patient Safety Day to raise awareness and promote action to reduce patient harm. This year’s theme, “Ensuring safe care for every newborn and child,” highlights the importance of protecting...
Long-term follow-up (LTFU) is a defining feature of oncology and cell and gene therapy (CGT) trials, where post-treatment monitoring often spans 2 to 15 years. These extended timelines allow regulators to assess long-term safety and efficacy from detecting delayed adverse...
Oncology & Hematology
Harnessing Innovation in Oncology: Insights from ASCO 2025
The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting offered a compelling look into the future of cancer care—one that is increasingly shaped by innovation, data, and a deeper commitment to the patient experience. From artificial intelligence (AI) transforming...
In the complex and costly world of new drug development, pharmacokinetic (PK) modeling has emerged as a promising method for driving more efficient and cost-effective clinical trials. This scientific approach leverages mathematical models to describe the relationship between drug dose,...
Clinical Development
Amplifying Patient Voices: The Impact of Advocacy Groups in Clinical Trials
In the realm of clinical trials, patient involvement is not just a nicety—it's a necessity. The patient voice has become central to the success of clinical trials, shifting the focus from traditional stakeholders like healthcare providers and regulatory bodies to...
Oncology & Hematology
Are You Engaging a CRO at the Right Point in Your Drug Development Program?
The traditional entry point for clinical research organization (CRO) engagement is delivery of the first clinical research study. However, companies with limited internal resources may benefit from engaging with a CRO as early as possible to leverage the full breadth...
The journey of developing effective treatments for rare diseases, particularly in a pediatric population, has its own unique challenges, including (but not limited to), a small population size, disease heterogeneity, and the absence of established endpoints to support regulatory decisionmaking....
Clinical Development
Celebrating World Cancer Day: An Interview with Leading Oncology Experts
Every year on February 4th, the world comes together to recognize World Cancer Day, a global initiative led by the Union for International Cancer Control (UICC). This day unites individuals, communities, and organizations in the fight against cancer while raising...
Clinical Development
Bringing an Oncology Asset to Market: In-House vs Outsource?
During the multifaceted journey of bringing a promising therapeutic to market, sponsors are faced with a critical choice—whether to manage asset development in-house or to outsource to a clinical research organization (CRO) partner. This decision can influence timelines, costs, control...