Clinical Trials On Bio
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Non-Clinical And Regulatory Expertise Accelerate Development Into Phase II-III Clinical Studies
6/21/2013
The client needed assistance with the development of non-clinical program and regulatory documentation to support Phase II-III clinical trials in Europe (daily dosing for one year).
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Benefits Of Non-Clinical Scientific And Regulatory Support For Late Phase Studies
6/17/2013
This case study illustrates how robust non-clinical advice and consultancy can expedite and accelerate drug development and increase the likelihood of regulatory acceptance
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Considerations When Selecting A CRO For Phase I Clinical Studies
6/17/2013
Phase I clinical trials are an integral step in the drug development process. Specific factors can influence the timelines and success of these studies. This white paper addresses the critical success factors for Phase I clinical studies and provides guidance on the appropriate capabilities, expertise and experience to evaluate as a sponsor selects a CRO.
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Avoiding The Gas-Guzzler: 8 Steps To More Productive Observational Studies
6/17/2013
When it comes to the subject of research studies, and specifically to observational, non-interventional studies. Suffice it to say that our industry needs to retool in order to cost-effectively respond to the need for these unique types of studies. By Jeff Trotter, Executive Vice President, Phase IV Development
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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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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
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Sourcing For Savings Case Study
5/29/2013
To help the client overcome these challenges, INC Research/inVentiv Health formed a strategic partnership with the biopharmaceutical company and took over responsibility for all of its trial-level clinical data management activities in the United States.
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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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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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Eight Best Practices For Compliant Essential Site Regulatory Documents
5/21/2013
In the push to initiate clinical trials, activating sites is understandably the primary focus—leaving essential site regulatory documents as a secondary priority and a bit of a “necessary evil.” Indeed, most sponsors and CROs approach essential site regulatory documents as a check-the-box exercise. By Patrice Pompa, Director, Regulatory Document Management Services and Kevin T. Williams, MBA, MS, Vice President, Corporate Development and Marketing, CFS Clinical