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Clinical Trials White Papers

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1-15 of 139 results
Softigel introduces new energy gummies at vitafoods
| By Softigel pbr
Who hasn´t needed a wake-me-up in the morning or hasn´t dragged a tired body to the end of the day? Regardless how we individually spend our day, the intensity of our routine, the sports practice or the stressful of our labor; the common consequence is the high demand and lack of energy.
Contract Research & Services > Clinical Trials > White Papers
A Survival Guide to Temperature Data in Life Sciences, by Almac
| By Almac
Regulations continue to evolve globally within the distribution arena of the Life Sciences industry. Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01)1 as well as Good Distribution Practices Supply Chain Integrity2 has made the most significant impact. There is an increased focus on companies being able to prove the quality and integrity of their drug product throughout the entire supply chain. The industry is facing stricter compliance demands from regulations and regulatory agencies are not always given clear guidance.
Contract Research & Services > Clinical Trials > White Papers
Almac: Changing the Dynamics of Temperature Controlled Shipping Solutions
| By Almac
In the typical clinical trial today, the cost of shipping and distributing supplies accounts for approximately 60 percent of the overall clinical supply chain. And when the cost of product spoilage from temperature excursions is added into the mix, it is no wonder that pharmaceutical companies, Clinical Research Organizations (CROs), and logistics vendors are all eagerly searching for efficiencies and ways to carve costs out of the process.
Contract Research & Services > Clinical Trials > White Papers
Almac Explores Interactive Response Technology: An Untapped Source of Historical and Real-Time Data for Risk-Based Monitoring
| By Almac
Risk-based monitoring has attracted the support of a diverse group of organisations in recent years. Regulators have released guidance encouraging the use of risk-based approaches to clinical trial quality, vendors have created technologies to support such methods, and large pharma companies have pooled their resources to drive adoption. Yet, despite this flurry of activity, the industry has overlooked a potentially useful source of real-time and historical data.
Contract Research & Services > Clinical Trials > White Papers
Almac Presents Modern Perspectives on Peptide Synthesis, an Introduction
| By Almac
The complexity of synthetic peptide products, whether as reagents used in research or as therapeutic APIs, is increasing. As researchers understand more about the biochemical systems which are targeted, and invent ever more sophisticated products, manufacturing methods must keep pace. We look in this article at a number of challenging product classes, the specific problems they present, and potential solutions: Long peptides; Multi-peptide cocktails; Site-specifically modified products.
Contract Research & Services > Clinical Trials > White Papers
Almac: Crystallisation of Pharmaceutical Compounds
| By Almac
The Almac Group explores the chemist's role in protecting intellectual property. It provides development and manufacturing services for Active Pharmaceutical Ingredients (APIs) to pharmaceutical industries worldwide. Over the past 40 years, we have made numerous discoveries that have become powerful intellectual properties (IPs) for our customers.
Contract Research & Services > Clinical Trials > White Papers
Reliable, Long-range Wireless Sensors for Environmental Monitoring
| By Vaisala pbr
The Vaisala viewLinc Monitoring System tracks environmental conditions wirelessly using Vaisala’s VaiNet wireless devices based on LoRa™* technology. By using a chirp spread spectrum (CSS)* wireless protocol, VaiNet provides robust communication that is extremely reliable over long distances and under harsh, complex and obstructed conditions.
Contract Research & Services > Clinical Trials > White Papers
Sciences Radiolabelling Brochure
| By Almac
Trust Almac with your 14C radiolabelling requirements and we will offer advice on the most appropriate label position for your molecule, including synthetic feasibility and metabolic stability.
Contract Research & Services > Clinical Trials > White Papers
Commerical Packaging
| By Almac
- Complementary US and UK operations, - Quality-driven, flexible packaging solutions, - Market leader for product launch of niche / orphan drug products, - Solid oral dose and biopharmaceutical packaging, - Packaging and artwork design, - Full serialisation and 2D matrix barcoding solutions.
Contract Research & Services > Clinical Trials > White Papers
Providing an Unparalleled Range of Contract Pharmaceutical Development and Manufacturing Services Globally for Over 40 Years
| By Almac
Only we can combine the expertise from our range of specialised services to provide you with the right solutions to help you develop and commercialise your products.
Contract Research & Services > Clinical Trials > White Papers
Building the Next Generation IRT: An Exclusive Look Under the Hood of IXRS®3
| By Almac
Interactive Response Technology (IRT) systems - used to manage patient interactions and drug supplies during clinical trials - perform a range of functions for sponsors, drug depots, and investigative sites. Yet, they are typically viewed by sponsors as a "painful necessity" rather than as a welcome, invaluable tool. That perception exists because the underlying technology is outmoded, and the user's experience is stuck in the pre-Internet era. While established systems are "tried and true" in that they have supported thousands of clinical trials over the years, they can also be tired and cumbersome.
Contract Research & Services > Clinical Trials > White Papers
Introducing Direct to Patient Shipments
| By Almac
Almac will ship the Clinical Trial Material (CTM) to participating clinical sites, where the drug is to be stored. Both shipping and storage of the CTM will follow standard procedures. Sites will interact with the Interactive Response Technology (IRT) provider in the usual way to obtain a kit assignment.
Contract Research & Services > Clinical Trials > White Papers
Bioanalysis of Biosimilars
| By PRA Health Sciences
Assessment of biosimilarity during non-clinical and clinical trials requires specific bioanalytical procedures. The concentration of the biosimilars and their reference compounds is established using pharmacokinetic (PK) methods. Immunogenicity assays are used to determine and further characterize any anti-drug antibodies (ADA) formed during these studies. These analytical methods are pivotal for establishing similarity of biosimilar products as compared to their reference compounds.
Contract Research & Services > Clinical Trials > White Papers
ECG Assessments During the Development of Oncology Compounds
| By PRA Health Sciences
Assessment of ECGs during the development of oncology compounds is challenging. Toxicity of these compounds often precludes the inclusion of healthy volunteers while a higher variability of ECG parameters in oncology patients can be expected due to disease, comedication, and co-morbidities. Recently, it was shown that the extraction of ECG data using the High Precision QT technique of iCardiac and Exposure Response analysis can result in a conclusive ECG assessment with a limited number of volunteers. Applying these techniques in a small-sized oncology study with dedicated PRA staff presents a unique opportunity for a conclusive and efficient cardiac safety assessment by ECG.
Contract Research & Services > Clinical Trials > White Papers
Transform Clinical Development Through Advances in Risk-Based Monitoring
| By Quintiles
This paper shares the challenges of clinical development along with an approach to trial execution gleaned from years of executing trials with risk-based monitoring (RBM) policies and processes.
Contract Research & Services > Clinical Trials > White Papers
1-15 of 139 results