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Clinical Trials White Papers

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16-30 of 140 results
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
Integration of Molecular Biomarkers into Clinical Development
| By Quintiles
In the first of this two-part series, strategic drug developers Eric Groves, Jason Hill and Christopher Ung explain why biopharma cannot afford to ignore the growing surge of interest in biomarkers in oncology and discuss their critical role in the modern-day clinical development process.
Contract Research & Services > Clinical Trials > White Papers
Personalizing Oncology with Genomics
| By Quintiles
Next-generation sequencing will transform oncology clinical trials and treatments for cancer.
Contract Research & Services > Clinical Trials > White Papers
Biomarkers: Recent Advances in Their Application to the Treatment of Hematologic Malignancies
| By Quintiles
Biomarkers hold promise in the diagnosis, prognosis and therapeutic stratification of hematopoietic malignancies. These heterogeneous diseases - including multiple myeloma, lymphomas and leukemias - are frequently characterized cytogenetically with diagnoses supported by genetic, immunohistochemical and flow cytometric analyses.
Contract Research & Services > Clinical Trials > White Papers
Integrating Biomarkers in Alzheimer’s Disease Trials
| By Quintiles
Review of compliance with biomarker assessments in Alzheimer’s disease clinical trials.
Contract Research & Services > Clinical Trials > White Papers
Biomarkers: Key to Better Rheumatoid Arthritis Drug Development and Treatment
| By Quintiles
Rheumatoid arthritis (RA) affects approximately 1% of the world’s population with an ever-increasing burden on health, quality of life and the economy.
Contract Research & Services > Clinical Trials > White Papers
Designing Wellness for Fun and Satisfaction: Gummies - Based Nutrition
| By Softigel pbr
The gummy delivery form for vitamins, minerals and supplements is the single-largest source of growth among the supplements category. Vitamin users report preference for gummy/soft chewable products because these offer not only pleasure and a fun experience, but efficacy and convenience. The selection of materials during the design process of the formula is critical for the final product in order to meet the expectations of the consumers, which is to find a healthy product that will give them a delicious reward as well. Based on the design and development process, this paper reviews review in detail the stage of selection of materials and validation as a critical phase to obtain a product that represents quality and stability as well as the specific requirements of the costumers and the consumers.
Contract Research & Services > Clinical Trials > White Papers
Biosimilars in Emerging Markets Is It A Level Playing Field?
| By PRA Health Sciences
Governments, healthcare payers, and social and health reforms, combined with the increased incidence of conditions such as cancer and diabetes are paving the way for increased uptake of biologic medicines in emerging markets. However, expensive biologic medicines can be prohibitive to many patients, creating a high level of unmet clinical need.
Contract Research & Services > Clinical Trials > White Papers
Defining the Future of Temperature Monitoring
| By TSS
Benefits of a cloud solution independent of the logger device.
Contract Research & Services > Clinical Trials > White Papers
Best Practices for Streamlining Electronic Implementation of Established COAs; Copyright January 2015
| By ERT
This paper addresses the best practices for building an electronic Clinical Outcome Assessment (eCOA) solution in support of clinical research as it relates to the operational and licensing compliance aspects of administering COAs on electronic platforms.
Contract Research & Services > Clinical Trials > White Papers
Symptoms and Impact of COPD Assessed by an Electronic Diary in Patients with Moderate-to-Severe COPD: Psychometric Results from the SHINE Study; International Journal of COPD; January 2015.
| By ERT
This paper presents the results of psychometric assessment data from a COPD eDiary developed by Novartis to provide a more detailed assessment of symptom frequency and severity and their impact on patients with COPD.
Contract Research & Services > Clinical Trials > White Papers
The Use of Ambulatory Blood Pressure Monitoring in Drug Development; Copyright, January 2015
| By ERT
This white paper delves into the basics of blood pressure, along with the well-documented limitations of standard and digital office blood pressure measurements. It reviews ABPM device functionality, common drug classes where blood pressure monitoring comes into play and compares the advantages and disadvantages of different monitoring options in clinical studies.
Contract Research & Services > Clinical Trials > White Papers
The Use of Continuous ECG Recordings (Holters) in Drug Development; Copyright, December 2014
| By ERT
Continuous 12 lead ECG recorders, often referred to as Holter devices, offer specific advantages to be considered over the standard 12 lead ECGs often collected during clinical trials for cardiac safety. This white paper explores the history of Holters, how sponsors, sites, and patients use these devices, and the benefits of continuous ECG recordings.
Contract Research & Services > Clinical Trials > White Papers
Predictive Value of Baseline electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) Assessments for Identifying Risk of Prospective Reports of Suicidal Behavior During Clinical Research; Innovations in Clinical Neuroscience; November 2014
| By ERT
This meta-analysis examined the ability of baseline eC-SSRS lifetime suicidal ideation and behavior categories to predict prospective reports of suicidal behavior in psychiatric and non-psychiatric research participants. The review of over 74,000 eC-SSRS assessments determined that increasingly more severe lifetime suicidal ideation at baseline was associated with a progressively greater likelihood of prospectively reported suicidal behavior during study participation.
Contract Research & Services > Clinical Trials > White Papers
16-30 of 140 results