The Role of Statisticians in Study Design and Why to Engage Them Early
Industry Featured Article Our latest article, published in Life Sciences Review and authored by our Allucent expert, Melanie Buitendyk, Director of Biostatistical Consulting, delves into the pivotal role statisticians play in the early stages of study design, offering insights into how their involvement can significantly streamline the development process. In the dynamic landscape of clinical […]
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5 Areas Where a Biostatistician Can Help
The FDA acknowledges the value of statisticians, involving them at every stage of the clinical trial process – and for a good reason. High-quality patient data is intrinsic to regulatory success, and must be properly managed to ensure integrity, compliance, and safety, requiring significant clinical study oversight. What role do biostatisticians play in relation to […]
Benefits of Bayesian Dose Escalation Designs for Oncology Studies
As acceptance of flexible trial designs continues to advance, many sponsors are increasingly exploring alternate methods for dose escalation to support identification of a maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) in open-label Early Phase or First in Human studies. Bayesian dose escalation designs have also coincided with advances in oncology therapy […]
Optimizing Trial Efficiency with Bayesian Dose Escalation Designs
As acceptance of flexible trial designs continues to advance, many sponsors are increasingly exploring alternate methods of dose escalation to support the identification of a maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) in open-label Early Phase or First in Human studies. Bayesian dose escalation designs have also coincided with advances in oncology […]
Respiratory Viral Infections: Progress and Innovation
The ongoing COVID-19 pandemic has brought into focus the impact that respiratory viral infections have on the health and well-being of the world’s populations. While so-called “emerging” pathogens like the SARS, MERS, and SARS-2 coronaviruses, along with avian and pandemic influenza, tend to grab the headlines, less well-recognized is the fact that respiratory infections caused […]
What Is CDISC and What Are CDISC Data Standards?
CDISC stands for the “Clinical Data Interchange Standards Consortium,” and is a global not-for-profit organization that actively develops data standards with the collective knowledge and experience of volunteers within the pharmaceutical industry. There are three major standards that CDISC supports which are, SDTM, ADaM, and SEND. The CDISC standards for clinical studies are SDTM and […]
Anticipating Obstacles to Approval Before Your Early Phase Oncology Study: Four Critical Areas to Consider
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have rigorous processes for reviewing applications for new drugs for marketing. By working with an experienced partner who can focus on the approval process from preclinical studies up to pivotal clinical investigations for you, the development is more likely to proceed along […]
What are Adaptive Design Clinical Trials?
An adaptive design allows certain prospectively planned modifications to be made to the study design after the trial’s initiation while maintaining the trials validity and integrity. If done correctly, this added flexibility to modify certain elements of the study design can lead to more informative and efficient study outcomes. Adaptive clinical trial designs have been […]
What are Real-World Data and How Can they Benefit Drug Development?
Real-world data (RWD) are data that come from sources other than traditional clinical trials and are becoming increasingly important to today’s healthcare decisions. Historically, drug developers have been limited to prospective randomized clinical trials as their primary avenue for achieving product approval. Recent technological advances and regulatory expansions, however, have broadened the possibilities available to […]