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61-75 of 164 results
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 > Contract Research > 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 > Contract Research > 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 > Contract Research > 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 > Contract Research > 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 > Contract Research > 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 > Contract Research > White Papers
Renal Impairment Studies in Early Development Services: Innovative Patient Pharmacology Models for Phase I-IIa Support
| By PRA Health Sciences
It is recommended to have renal impairment trials conducted relatively early in the clinical development process, because the outcome may influence the patient population as well as the inclusion and exclusion criteria of Phase II and III trials. The timing of these trials is generally before or in parallel with Phase II.
Contract Research & Services > Contract Research > White Papers
Seamless Drug Development
| By PRA Health Sciences
The success rate of drug development has been studied extensively over the years and discussed in numerous publications. In an important recent paper by Hay et al (Nat Biotechnol. 2014;32:40-51), the overall likelihood of FDA approval for products entering clinical phase was estimated at approximately 10%.
Contract Research & Services > Contract Research > White Papers
Point of Care Testing in Clinical Trials
| By Woodley Equipment Company
Point of care (POC) testing is diagnostic testing performed in the vicinity of the patient, avoiding the need to send samples to a central laboratory. Results generated by POC devices can be utilised in clinical trials as decision-makers prior to administering treatments or results can be used as actual trial data.
Contract Research & Services > Contract Research > White Papers
User vs. Software-Dependent Variability of ELISPOT Counts Obtained from ten Different Laboratories
| By CTL Laboratories
In ELISPOT assays, cytokine spots produced by antigen-specific T cells show a broad spectrum of sizes and densities over variable background. Therefore, even experienced investigators are likely to come up with different spot counts when subjectively judging the minimal spot size/density to be counted and the maximal spot size for the cut off between singlecell-derived spots vs. those created by cell clusters. This study aims to find out whether statistics-based automated gating can harmonize spot counts obtained in different laboratories.
Contract Research & Services > Contract Research > White Papers
ELISPOT Assays Provide Reproducible Results Among Different Laboratories for T-cell Immune Monitoring - Even in Hands of ELISPOT's Inexperienced Investigators
| By CTL Laboratories
Measurements of antibodies in bodily fluids (e.g., by ELISA) have provided robust and reproducible results for decades and such assays have been validated for monitoring of B-cell immunity. In contrast, measuring T-cell immunity has proven to be a challenge due to the need to test live cells in functional assays ex vivo. Several previous efforts looking into the reproducibility of ex vivo T-cell assays between different laboratories, or even within the same laboratory, have provided rather discouraging results.
Contract Research & Services > Contract Research > White Papers
How Frequently are Predicted Peptides Actually Recognised by CD8 Cells?
| By CTL Laboratories
Detection of antigen-specific CD8 cells relies on the use of peptides that can bind to HLA-Class I molecules. There is extensive knowledge on individual HLA-alleles’ peptide binding requirements and for many antigens immunogenic peptides have been defined. The 32 individual peptides that comprise the CEF peptide pool represent such well-defined peptide determinants for Cytomegalo, Epstein Barr, and Flu virus. We tested 42 healthy human donors on the accuracy of these peptide predictions.
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Publications by Theme
| By CTL Laboratories
For over 15 years, Prof. Lehmann and the team of scientists working with him have been focused on establishing the scientific foundations of ELISPOT assays and to test the utility of the technology in various fields of T cell diagnostics. CTL’s peer-reviewed publications are listed here by theme with the hopes of providing a useful reference for your research.
Contract Research & Services > Contract Research > White Papers
Characterisation of the CMV-Specific CD4 Cell Response
| By CTL Laboratories
Most humans become infected with HCMV. Typically, the immune system controls the infection, but the virus persists and can reactivate in states of immunodeficiency. While the HCMV-specific CD8 cell and antibody response has been accessible to investigation, studies of the CD4 cell subsets have been limited by the low frequency of the antigen-specific CD4 cells in PBMC.
Contract Research & Services > Contract Research > White Papers
61-75 of 164 results