Download White Paper : Engaging Clinical Trial Sites – The Role of the Clinical Trial Liaison

Enrollment in clinical trials is heavily dependent on two very important customers: the research subject and the clinical trial investigator. Research subjects are highly valuable since it is obviously impossible to complete a clinical trial without a willing group of participants. There are many groups and even entire companies that specialize in engaging potential subjects and connecting them to clinical …

Download White Paper : Translating Cancer Genomics for personalized approach to treating cancer

Over the past few decades, the approach to prevention, diagnosis and treatment of cancer has radically shifted from organ-based to morphology-based and most recently, to genetics-based. Personalized or precision medicine (tailoring a treatment for a patient’s particular disease at a precise time point) is being performed every day at different levels in the clinical setting.The study of cancer genomics has …

pra, risk management, drug safety, world drug safety congress europe

Risk Management Planning and Mandated Post-Authorization Studies

Complex pharmacovigilance legislation in an evolving regulatory landscape has left drug makers searching for current, efficient and more meaningful solutions for their drug safety challenges, especially in the post-marketing arena. Companies are seeking expert advice and customized approaches to effectively collect, manage and analyze real-world evidence for a competitive advantage. Download whitepaper “Risk Management Planning and Mandated Post-Authorization Studies” from Agnes …

Benefit Risk Management

Be Prepared. Benefit risk management is mandated by current regulations. As existing regulations are updated and new regulations emerge in all regions, especially in the European Union and United States, the requirements placed on drug development and Marketing Authorization Holders for safety and benefit-risk assessment are steadily increasing. This has led to a significant increase in suitable resource needs. In …

pra, whitepaper, human, liability, clinical trials

Download: Expert Solutions for Human Abuse Liability Trials

Human abuse liability data is now considered a critical piece of information during the new drug application (NDA) review process for most treatments involving central nervous system (CNS) indications and those with abuse deterrent or tamper resistant properties. As a global strategic partner for pharmaceutical and biotech companies in Phase I development, PRA’s Early Development Services (EDS) team is highly …

pra, whitepaper, human, liability, clinical trials

Download whitepaper: Risk-Based Monitoring for Late-Phase Research

The growing consensus among clinical researchers and regulatory authorities is that risk-based monitoring (RBM) is more likely to ensure patient protection and overall study quality, and allows for monitoring that can be more effective than the traditional model of routine visits to all sites with 100% source data verification (SDV). A number of factors are leading to the paradigm shift …

PRA Opens Office in Singapore, Centralized Operations to Enhance Regional Presence

New office will serve as PRA's central clinical operations location for the region, strengthening the quality and timeliness of our deliverables to sponsors. Contributed by PRA: PRA, a leading Clinical Research Organization, continues our expansion across the burgeoning Asia-Pacific region with the recent opening of an office in Singapore. The Singapore facility, conveniently located in the heart of the city-state, …