The technology transfer of a manufacturing process to a contract development and manufacturing organization (CDMO) is a key step on the road to developing and commercializing biopharmaceutical products. Successfully executing this step is critical to clearing regulatory expectations, avoiding production...
Premier Research
Real-World & Late Phase
Leveraging Real-World Data & Real-World Evidence to Support Regulatory Decision Making
The FDA is committed to increasing sponsor opportunities to apply RWD and RWE to support regulatory decision-making.1 The goal is to use quantities of available data, streamline the drug development process, and learn how interventions perform in real-world use, outside...
Real-World & Late Phase
A Fit-for-Purpose Path Forward: Linking RWD to Your Overall Data Strategy
Real-world data (RWD) and real-world evidence (RWE) have become an increasingly important part of the medical product development landscape. These tools can enable sponsors to optimize clinical trial designs and demonstrate the real-world effectiveness of new medical products. Part 2...
Women's Health
Teaming Up with Sites During Trial Design
According to the Tufts Center for the Study of Drug Development (Tufts CSDD), nearly half of all clinical studies require substantial—and potentially avoidable—protocol amendments that lengthen timelines and increase costs. Tufts CSDD also notes that more than half of the...
A quality electronic Trial Master File (eTMF) is essential to the product development and approval process, as it is the foundation for clinical trial inspections by competent authorities. eTMFs for drug, biologic, and medical device trials should be actively managed...
Real-World & Late Phase
What is Real-World Data and Evidence and How It Can Facilitate Clinical Development
The 21st Century Cures Act (Cures Act)1 signed into United States law in 2016 aims to accelerate medical product development and bring innovations to patients faster through real-world evidence (RWE) to support regulatory decision making. Incorporating real-world data (RWD) and...
One of the specialized capabilities in Premier Research's toolbox is coordinating the Active Substance Master File (ASMF) submission process on behalf of sponsors. The ASMF procedure (formerly known as the European Drug Master File [EDMF] procedure) has in recent years...
Managing clinical trials requires extensive planning of patient enrollment. Clinical trials may be more cost-effective with better forecasts of recruitment. A variety of circumstances influence the enrollment of subjects. Several factors to consider, including the rarity of the condition being...
Preparing for regulatory submissions and interactions requires seamless communication and continuity across multiple disciplines. While many consulting companies offer regulatory project management as a capability, Premier Research Regulatory Project Managers (PMs) elevate the position by acting a single point of...
Oncology & Hematology
7 Factors Fueling the Growth of Oncology Trials in Asia-Pacific
Oncology clinical trial activity in the Asia-Pacific (APAC) region has been robust over the past decade, increasing 138 percent from 2010 to 2020.1 In the past, most studies conducted in APAC countries were later studies, but there has recently been...