Quality

Clinical Research: Phase 1 - Phase 4

Premier Research: Not Just Life Science. Amazing Science.

This life is amazing. Each step. Each gaze. Alone, or together as one, from deep inside, comes who we are. Part science. Part magic. Amazing. Always moving toward the light of discovery. Driven by what’s yet unmet. Across the world around us, decoding the secrets of the worlds within us. We go where that work...

Clinical Research: Phase 1 - Phase 4

ePremier CTMS: The Central Organizing Principle for Successful Studies

Across the industry, most trials don’t have access to real-time results…which leads to delays. 95% of those delays last longer than a month. Addressing this challenge means tackling the underlying problems of data being held in disparate places, and failure to predict and address risk. Our Premier One Ecosystem captures all the data related to...

Clinical Research: Phase 1 - Phase 4

ePremier Study Start-Up: Where a Successful Trial Launch Begins

Industry-wide, spreadsheets have long been the go-to method for tracking clinical trial start-up. Premier Research developed the Premier One Ecosystem to create a paperless, electronic data process, start to finish. Trials begin with our Study Start-Up application, which automates collection of ALL the data related to your trial, then optimizes it to decrease cycle times...

Clinical Research: Phase 1 - Phase 4

Key Changes in the Revised EMA Guidance on Clinical Trials During COVID

In February, the European Medicines Agency (EMA) released the fourth version of its Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic. As the pandemic continues to impact clinical research worldwide, these updated guidelines reflect the EMA’s evolving stance, clarifying questions raised by previous versions and taking into account the most recent...

Medical and Regulatory Affairs

The First Step for Streamlined CMC Development: Optimize the Target Product Profile

The ultimate goal of any drug development program is to obtain regulatory approval with the desired prescribing information. Beyond that, developers hope to obtain this approval in the shortest amount of time and with the most efficient use of resources. In an article published in Trends in Biotechnology,1 researchers found that the approved drugs and...

Clinical Research: Phase 1 - Phase 4

Rethinking Data Quality Best Practices in the Era of Decentralized Clinical Trials

Pandemic-related disruptions have accelerated much-needed change in clinical operations, but this change has been accompanied by questions about data collection and data quality. In a recent survey commissioned by Oracle Health Sciences, more than 75 percent of industry respondents indicated that limitations in patients’ ability to attend on-site visits sped up their adoption of decentralized...

Consulting

Outsourcing-Pharma.com: Holistic Approach Benefits Drug Development

Professionals focused on drug development are charged with making the most of their resources, maximizing the value of their work, and bringing effective products to market as quickly as they can without compromising quality or safety. It is a long list of responsibilities, and development professionals struggle to balance all of them. Sameena Sharif, senior...

Consulting

Entering a New Clinical Phase of Non-Traditional Data Sources

This is part two of a two-part series based on our recent webinar Setting a Real-World Strategy in an Evolving Clinical Research Environment. You can read part one here. In this post, we will cover non-traditional data points, their use in randomized control trials (RCTs), and how they contribute to a successful data strategy. The...

Consulting

Can Your Clinical Data Strategy Keep Pace?

Following up on our recent webinar Setting a Real-World Strategy in an Evolving Clinical Research Environment, this is the first of two blogs on this critical topic. In this post, we’ll cover the importance of process in ensuring a robust strategy is in place for the acquisition and analysis of trial data in the face...

Medical and Regulatory Affairs

FDA Releases Draft Guidance for Transdermal Product Development

Transdermal and topical delivery systems (TDS) are important dosage forms that allow delivery of a drug to local tissue or provide systemic delivery through the skin. These drug products provide a number of advantages for patients, but can be challenging to develop. In November 2019, the FDA issued a draft guidance entitled Transdermal and Topical...