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Clinical Trials White Papers

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61-75 of 139 results
GMP Warehouse Mapping - Step-by-Step Guidelines for Validating Life Science Storage Facilities
| By Vaisala pbr
This step-by-step paper describes how to map a warehouse to comply with internationally recognized GMPs and regulatory requirements.
Contract Research & Services > Clinical Trials > White Papers
Monitoring Systems - Sorting Out Wireless
| By Vaisala pbr
This white paper describes the most common methods of connecting sensors to a monitoring system focusing on selecting wireless options.
Contract Research & Services > Clinical Trials > White Papers
Nine Things you Need to Know About Continuous Monitoring Systems in FDA-Regulated Environments
| By Vaisala pbr
The white paper outlines nine crucial evaluation points that will allow you to select the monitoring system best suited to your monitored applications, controlled environments and GxP facilities.
Contract Research & Services > Clinical Trials > White Papers
The Process of Informed Consent
| By CenterWatch
In this ACRP guidance document, the Association describes how to best structure the informed consent process in accordance with best practices.
Contract Research & Services > Clinical Trials > White Papers
The Role of Biostatistics in the Prevention, Detection and Treatment of Fraud in Clinical Trials
| By CluePoints
Recent cases of fraud in clinical trials have attracted considerable media attention, but relatively little reaction from the biostatistical community. In this paper we argue that biostatisticians should be involved in preventing fraud (as well as unintentional errors), detecting it, and quantifying its impact on the outcome of clinical trials.
Contract Research & Services > Clinical Trials > White Papers
Ensuring Trial Validity by Data Quality Assurance and Diversification of Monitoring Methods
| By CluePoints
Errors in the design, the conduct, the data collection process, and the analysis of a randomized trial have the potential to affect not only the safety of the patients in the trial, but also, through the introduction of bias, the safety of future patients. Trial monitoring, defined broadly to include methods of oversight which begin when the study is designed and continue until it is reported in a publication, has a role to play in eliminating such errors.
Contract Research & Services > Clinical Trials > White Papers
A Statistical Approach to Central Monitoring of Data Quality in Clinical Trials
| By CluePoints
Classical monitoring approaches rely on extensive on - site visits and source data verification. These activities are associated with high cost and a limited contribution to data quality. Central statistical monitoring is of particular interest to address these shortcomings.
Contract Research & Services > Clinical Trials > White Papers
The Pulse on Study Conduct -- Best Practices and Critical Strategies to Ensure Site Success
| By CenterWatch
Industry expert Elizabeth Blair Weeks-Rowe offers solutions to achieve study conduct success from ensuring clean data to preparing for a co-monitoring visit.
Contract Research & Services > Clinical Trials > White Papers
The Pulse on Recruitment -- Exploring the Use of Social Media and Online Tactics in Patient Recruitment
| By CenterWatch
Industry experts Cara Danchak and Bonnie A. Brescia offer insight into the challenges and potential benefits of social media and online patient recruitment.
Contract Research & Services > Clinical Trials > White Papers
Site Landscape Shrinking, Losing Most Active PIs
| By CenterWatch
High turnover and an influx of novice investigators have been the key drivers plaguing the site workforce recently. CenterWatch analyzes the reasons for the shift and the affects it's having on the industry.
Contract Research & Services > Clinical Trials > White Papers
Issues in Research Management: Protocol Challenges in the Era of Complexity
| By CenterWatch
Learn about site/sponsor responsibilities and effective strategies to manage protocol amendments.
Contract Research & Services > Clinical Trials > White Papers
Effectively Outsourcing Medical and Laboratory Equipment Procurement
| By Woodley Equipment Company
With investigator sites located across the globe, it is increasingly important to ensure that they all have the right equipment to undertake a clinical trial to its successful conclusion. Robin Wickham, general manager, explains how Woodley Equipment Company can source the most appropriate equipment for you, and ensure a smooth trial is delivered on time and in budget.
Contract Research & Services > Clinical Trials > White Papers
Challenges of the Clinical Trial Supply Chain for Stem Cell Products
| By Biotec Services International Limited
A high percentage of new therapies being announced and discussed in the news currently are based on stem cell products. Products derived from embryonic stem cells and adult cells are now beginning to enter the clinical trial phase of development. As research has developed in this field, so too have the regulations to control, not only the use and production of the cells, but also the products derived from these cells.
Contract Research & Services > Clinical Trials > White Papers
Batch Control & Touch Technology
| By COPA-DATA
Wherever you are in the automation process, an interpretation is needed between the process engineers ‘instrument’ - the automation software and process equipment - and the process being controlled. The smooth operation and success of the process is based on the effective interpretation of the control system: from a digital representation into an analogue actuation in the real world.
Contract Research & Services > Clinical Trials > White Papers
61-75 of 139 results