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
Clinical Trial Innovation Update
This article will summarize the discussion on innovation that took place at this years Cambridge Health Institute’s Clinical Trial Innovation Summit.
Hands Across the Sea for EU-US GMP
The mutual recognition agreement between the European Union and the US FDA now covers 15 European countries, after Portugal won US recognition in mid-September.
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.
Noteworthy
How Data and Analytics Can Improve Clinical Trial Feasibility
By Venkat Sethuraman, PhD, Sharma Ramanathan, Deva Devesa, Jessica Rine
These seven key building blocks for success are outlined to help companies develop and implement a data-and-analytics-driven approach to clinical trial feasibility.
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.
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.
Webcasts
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