Featured Articles
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Which Type Of Contract Is Right For Your Clinical Research Project?
8/28/2014
You’ve Chosen A Contract Research Organization (CRO) to partner with on your next clinical research project or program, and now it’s time to sign a contract. By Jamie Hahn
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Objectives And Considerations In Developing An Integrated Summary Of Efficacy (ISE)
8/28/2014
A new drug application (NDA) covers information about a product from inception through clinical trials. By Ben Vaughn
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Key Tips For Orphan Product Development
8/28/2014
Selecting a partner for drug development is tricky. This is especially true when selecting a CRO to assist with orphan product development. Dr. David Shoemaker
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Could Your Phase II Or Phase III Clinical Trial Benefit From A Special Protocol Assessment (SPA)?
8/28/2014
Special Protocol Assessments (SPA) are an opportunity to get upfront input and buy-in from FDA on the scientific, regulatory, and statistical rigor of your planned adequate and well controlled clinical trial. SPAs can be done for clinical protocols, non-clinical carcinogenicity protocols, and CMC stability protocols.
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4 Types Of Efficacy Outcomes To Consider In Phase II Clinical Trials
8/28/2014
You will often hear the phrase “learn and confirm” related to clinical trials. Phase II clinical trials are where you “learn” about your treatment and phase III clinical trials are where you “confirm” what you know for regulatory agencies. By Dr. Karen Kesler and Dr. Andrea Mospan
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4 Tips For Planning The RFP Process For Clinical Trial Services
8/28/2014
Before you request bids from contract research organizations (CROs) for clinical trial services, it’s important to spend time planning your request for proposal (RFP) process. By Jamie Hahn
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3 Key Questions When Developing The Integrated Summary Of Safety (ISS)
8/28/2014
A New Drug Application (NDA) covers information about a product from inception through clinical trials. The integrated summary of safety (ISS) is a section of the NDA that provides comprehensive safety information collected throughout the development program. By Rob Woolson
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Choosing The Right System For Your Clinical Trial: The Differences Between EDC And IVR/IWR
8/28/2014
Sometimes it’s difficult to determine the best tool for a job, especially when technologies are developed in parallel to handle similar tasks. Take Interactive Response Technology (IxR) and Electronic Data Capture / Electronic Case Report Forms (EDC), for example. By Steve Palmatier
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6 Tips For An Effective Kick-Off Meeting For A Clinical Trial
8/28/2014
Kick-off meetings happen routinely at the start of a new clinical trial. Often, they fail to offer participants the information they need or to engage project team members in a way that helps them retain key information.
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5 Challenges In Site/CRO Relationships
8/28/2014
Strong Working Relationships between clinical trials sites and the CRO managing the study are critical to successfully executing a clinical trial.