Clinical Monitoring White Papers & Case Studies
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SynteractHCR Full-Service CRO Brochure
3/4/2016
SynteractHCR is a multinational clinical research organization, formed from the merger of Synteract with Harrison Clinical Research in 2013, which provides global, full-service clinical trial services. We have more than two decades of experience supporting biopharma companies in all phases of clinical development across multiple therapeutic areas. We customize programs that will deliver timely, high quality data to help you get to decision points faster, taking time and cost out of drug development.
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10 Insider Tips For eCOA Implementation
1/8/2016
If your organization has yet to adopt the use of eCOA (electronic clinical outcome assessments) in your clinical trials, then this white paper on successfully implementing the use of this technology should be of interest to you.
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Overcoming Complexity On A Phase 2 Glaucoma Study
5/1/2015
A Phase I/II multi-site study needed to enroll more than 100 patients across three distinct cohorts on an exceeding complex protocol.
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Unblinded Monitoring In HCV Trials, A Case For A New Standard
6/17/2013
The goal of current HCV clinical research is to identify new antiviral agents specifically targeting hepatitis C (STAT-C therapies) and to determine how best to individualize treatment regimens in order to optimize outcomes (i.e., increase the SVR rate) and minimize both drug toxicity and the development of resistance. By Cal Astry, PhD; Marion Morrison, MD
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Bioanalytical Development Services Brochure
5/29/2013
INC Research/inVentiv Health provides high quality bioanalytical services across the entire continuum of drug development. Our significant experience with small and large molecules, peptides, immunochemistry, LC/MS/MS, HRMS, GC/MS/MS and ICP-MS, combined with having one of the largest capacities in the industry, allows us to blend innovative science with effective, validated processes to deliver quality data on time, every time.
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Recruiting Patients With Impaired Renal Function Case Study
5/29/2013
According to FDA Draft Guidance published in March 2010, a pharmacokinetic (PK) study should be conducted in patients with impaired renal function when the drug is likely to be used in such patients and when renal impairment is likely to mechanistically alter the PK of the drug and/or its active metabolites.
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Improve Accuracy And Efficiency In Data Collection For Mental-Health Evaluations And Assessments
5/29/2013
MedAvante is a global provider of centralized, expert psychological rating services to the pharmaceutical, biotechnology, and medical device industries.
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Phase II Alzheimer's Case Study
5/29/2013
A double-blind, Phase II, placebo-controlled clinical trial to evaluate the safety and efficacy of a novel compound in subjects with mild to moderate Alzheimer’s disease.
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Phase IV Clinical Trials Brochure
5/29/2013
INC Research/inVentiv Health Late Stage leaders help world–class companies bridge the gap from development to commercialization.
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Top Nine Opportunities For Improving Observational Research
5/29/2013
We recently received a Request for Proposal (RFP) from a large pharmaceutical company for an Observational Study to be conducted over the course of five years in several countries worldwide, involving hundreds of sites and thousands of patients. By Jeff Trotter, Executive Director, Phase IV Development