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Clinical Trials White Papers

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31-45 of 140 results
Temperature Monitoring Solution - CCIS
| By TSS
CCIS provides centralised control over global operations performance and is tailored to suit each user level. No matter your corporate role, CCIS helps you tackle the challenges you face, both today and tomorrow.
Contract Research & Services > Clinical Trials > White Papers
Global Temperature Monitoring Solutions: For the Life Science Industry
| By TSS
TSS’ cloud solutions enable life science companies to take informed decisions, to ultimately ensure global patient safety.
Contract Research & Services > Clinical Trials > White Papers
Catch a Wave and You’re Sitting on Top of the World:How Information Technology is Leveling the Playing Field
| By Merge eClinical
Some 50 years ago, The Beach Boys offered up this observation: “Catch a wave and you’re sitting on top of the world.” They may have been singing about the virtues of surfing, but the refrain is applicable to a lot more than just hanging 10. It is no surprise that since 2000, there’s been a tidal wave of information technology advancements that’s been gathering size, speed and intensity. This wave has fundamentally reshaped how, when and where we communicate and conduct business.
Contract Research & Services > Clinical Trials > White Papers
Achieving Cost and Process Efficiencies with Online Endpoint Coordination and Adjudication
| By Merge eClinical
Clinical trials increasingly rely on endpoint adjudication to better assess patient events and provide standardised endpoint classifications. The increased trend toward the use of endpoint adjudication in a wider variety of clinical trials is being driven by regulatory, clinical, business and technology trends:
Contract Research & Services > Clinical Trials > White Papers
The Value of Biobetters
| By PRA Health Sciences
The market of biologics is growing at a nearly twice the rate of pharma as a whole. Biologics are expected to account for approximately 17% of total global spending on medicines by 2016, and reach an overall market value of $200 billion to $210 billion in 2016, up from $157 billion in 2011.Seven of the top 10 global medicines by spending will be a biologic within the next 5 years.
Contract Research & Services > Clinical Trials > White Papers
Global Biosimilar Development
| By PRA Health Sciences
Many different terms are used in different parts of the world to describe “biosimilar products.” It is important to understand and differentiate true biosimilars from others because of the potential concern for patient safety and efficacy, and the misconceptions that can arise from misleading published reports.
Contract Research & Services > Clinical Trials > White Papers
Global Capabilities in Central Nervous System Research
| By PRA Health Sciences
PRA Health Sciences’ (PRA) Early Development Services (EDS) group has a long-standing track record of early clinical development work in various CNS indications through our global clinical facilities.
Contract Research & Services > Clinical Trials > White Papers
Sponsor and CRO Pharmacovigilance Alliances
| By PRA Health Sciences
Outsourcing pharmacovigilance activities is a standard business practice in a rapidly expanding market segment. In the past, outsourced safety services were limited due to concerns about confidentiality, data security and liability in cases of regulatory non-compliance, which are all still important considerations today.
Contract Research & Services > Clinical Trials > White Papers
Translating Cancer Genomics Into a Personalised Approach for Cancer Patients
| By PRA Health Sciences
This white paper provides a brief history of oncology genomics, including development, uses in improving patient care, current achievements and challenges and the future direction of cancer genomics.
Contract Research & Services > Clinical Trials > White Papers
Favourable Regulatory Procedures in The Netherlands Phase I-IIa
| By PRA Health Sciences
The EU Clinical Trials Directive (CTD) has been fully implemented in The Netherlands. Prior to beginning to a clinical trial, an identical Clinical Trial Application (CTA) dossier must be submitted to an accredited Ethics Committee (EC) and to the Central Commision on Research in Humans (the Competent Authority [CA] in The Nettherlands).
Contract Research & Services > Clinical Trials > White Papers
Risk - Based Monitoring for Late - Phase Research: Strategies for Real - World, Post - Approval Studies
| By PRA Health Sciences
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).
Contract Research & Services > Clinical Trials > White Papers
Risk Management Planning and Mandated Post - Authorisation Studies: Risk Management and Late Phase Studies for Real-World Research
| By PRA Health Sciences
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 customised approaches to effectively collect, manage and analyse real-world evidence for a competitive advantage.
Contract Research & Services > Clinical Trials > White Papers
Human ADME and Studies with Radiolabeled Compounds: Phase I-IIa
| By PRA Health Sciences
Radiolabeled medication is widely used in the assessment of human ADME and also increasingly in assessing absolute bioavailability (BA). Conducting an ADME study early in the clinical development program - generally before or in parallel with Phase IIa - is prudent since the outcome may generate the need for additional toxicology studies.
Contract Research & Services > Clinical Trials > White Papers
Hepatic Impairment Studies in Early Development Services: Innovative Patient Pharmacology Models for Phase I-IIa Support
| By PRA Health Sciences
PRA Early Development Services (EDS) has established a group of experts dedicated to early phase patient studies. Our innovative Patient Pharmacology Services (PPS) features a unique scientific/medical and operational model that enables us to conduct studies in patients with hepatic impairment following the same processes and guidelines that we apply to traditional Phase I or Phase IIa trials.
Contract Research & Services > Clinical Trials > White Papers
31-45 of 140 results