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
Sharing Stories of Clinical Trial Participation from Start to Finish
How mapping patients’ health journeys can drive a deeper understanding of their experiences and motivations.
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.
ACT TV
Events
Rare Diseases & Orphan Products Breakthrough Summit
October 15 - 16, 2018
Marriot Wardman Park, Washington, D.C.
Blogs
Quiz Time: What Methods Would You Use for HTA?
Imagine you are in charge of European legislation on pharmaceuticals. Imagine you've been told to draft rules on how to conduct clinical assessments at European level to help measure the value of a medicine. What would you go for?
FDA Seeks Reliable Patient Information to Support Regulatory Decisions
As FDA continues to advance the role of patients in designing clinical trials with meaningful and accurate endpoints, it is seeking more input from stakeholders on how best to identify clinical outcomes most important to patients and caregivers.
New Data Sharing Platform—DataCelerate—Aims to Improve Clinical Development
In this interview, Michael J. Graziano, PhD, DABT, Vice-President, Drug Safety Evaluation for Bristol-Myers Squibb and leader of the BioCelerate Toxicology Data Sharing Initiative, provides more details about the DataCelerate platform.
News
Latest Business and People News
Oct 15, 2018
Novotech and CNS Deal Expands CRO Services
Oct 15, 2018
Noteworthy
Improved Understanding of Psoriasis Buoys Treatment Hopes for Patients
Advances in our understanding of the genetic, immunological, and environmental factors that contribute to the pathogenesis of psoriasis have led to the development of very effective precision therapies that alleviate patient morbidity and improve quality of life, especially for patients with moderate to severe disease.
RBM: Barriers to Adoption
By Applied Clinical Trials Editors
The results of a 2018 survey of sponsor, CRO, and technology companies.
A Roadmap to Phase I Challenges for Cell and Gene Therapy Products
By Nicole Gallo, Jason Birri, Chris Kelly, Julie Kristen Hagan
Cell and gene therapies are the latest wave of advanced technologies that will shape the face of the modern-day biopharma arena, enabling a path to pinpoint a faulty gene or cellular mechanism at the root of a specific disease.
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.
White Papers
Webcasts
Sponsored Links
