Peer-Reviewed Articles
To Sign or Not to Sign FDA Form 1572?
Exploring that pivotal question for clinical investigators, sponsors, and global CROs.
Does PI Certification Make a Difference?
By Kathryn Rena Hodges, PhD, Duane Akroyd, PhD
Certified principal investigator certification as a predictor of major and critical protocol deviations in clinical trials.
Monoclonal Antibodies: Clinical Pharmacology Knowledge in Support of FIH and Early Development
There are several pharmacokinetic factors and peculiarities that should be considered carefully when designing and running first-in-human (FIH) studies for monoclonal antibodies.
CISCRP Corner
Patient Experiences with Clinical Trial Medicines and Instructions
Providing easy to understand and culturally appropriate investigational medication education and support can make all the difference in improving the patient experience.
Patient Perspectives on Seeing Trial Results
The third in a series of results from the Center for Information and Study on Clinical Research Participation’s (CISCRP) landmark 2017 Perceptions & Insights Study.
Patient Input into Leveraging the Healthcare Professional’s Role
The second series of findings from CISCRP's 2017 Perceptions & Insights Study.
ACT TV
Events
Rare Diseases & Orphan Products Breakthrough Summit
October 15 - 16, 2018
Marriot Wardman Park, Washington, D.C.
Blogs
FDA Supports Streamlined Trials for New Antimicrobials
The critical need for new medicines to combat infectious diseases is prompting FDA to join with other federal health agencies and the biomedical research community to advance the science, regulatory policies, and reimbursement strategies to promote innovation in this area.
The European Union Guessing Game
The workings of the European Union are notoriously complicated, with the result that misunderstanding is commonplace, even among those who might like to know more about it.
Vendor? Strategic Partner? The CRO’s Evolving Role in Clinical Trials
Krista Armstrong explains the CRO's evolving role within clinical trials.
Noteworthy
Evolution of Clinical Trial Agreement Review in Malaysia Through Clinical Research Malaysia
By Nurul Atiqah Abd Rahman, Norafizaa Yusop
A reduction of Clinical Trial Agreement Review times has caused rapid development in Malaysian clinical trials.
Leveraging a Unified Data Model to Drive Collaboration and Clinical Trial Efficiency
By Elisa Cascade, Claire Sears, PhD
This article will focus on a case study example of a collaborative effort to share investigator, site, and study information across companies, and on the single data model that underpins it.
Why Data Integrity Should be an Integral Part of the Pharma Biotech Industry Culture
Data integrity is the essence of GMP, the cornerstone of how the industry operates, and it is vital that all organizations embrace it to survive the rapidly changing life sciences landscape.
eBooks
Clinical Trials for Rare Diseases
This eBook will focus on advancing research, drug development, and trial management in rare diseases. Articles cover considerations from virtual trials and eCOA to the case for highly-skilled CRAs.
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