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Single-Patient Expanded Access: WIRB experience in 2018
In 2018 WIRB approved 100% of the single-patient EA requests that were submitted for review.
Virtual Clinical Trials Best Practices
Invert to Convert: Rethinking Patient Recruitment and Enrollment Strategies
Looking Ahead in 2019 Whitepaper
In this paper, 17 WCG thought-leaders provide insights on what they anticipate in 2019 in clinical trial technology, regulatory changes, and scientific developments.
Limited IRB Review: Are You Prepared for January 21st?
On January 21, 2019, most federally funded research will need to follow the 2018 Requirements of the Common Rule. This post talks through the original and revised rules, and how they may apply to you.
Is the Government Shutdown Already Impacting Drug Development?
For biopharma sponsors, investigators, patients and families, these limitations are already translating into real impacts on development programs.
Infograph: Rethinking Patient Recruitment
Despite advances in science, medicine and tech, 90% of clinical trials struggle to meet enrollment. We propose flipping the funnel to address site resourcing issue and convert recruits into enrollees.
Addressing Suggestibility as a Psychological Phenomenon in Clinical Trials
It is important to understand patient perspectives and to anticipate how subjects in research studies may be impacted by the presence of digital tools, devices, and mobile health applications
Setting Up Your Oncology Studies for Success from the Start
Removing Barriers: Reimbursement and Compensation for Participation in Oncology Clinical Trials
The impact of participant payments on clinical trial recruitment.
Finding New Solutions to a Current Unsustainable Model of Clinical Trial Contracts & Budgets
Genetic Counselors at the Forefront of Helping Researchers Brace for the "Silver Tsunami" of CNS Disorders
An aging population is triggering a “silver tsunami” of neurodegenerative diseases like Alzheimer’s and Parkinson. At the same time, precision medicine holds great promise for many CNS disorders.
Drug Safety Executive Summary eBook
Precision Medicine: A Glossary of Terms
As genetic testing becomes an integral part of clinical development programs, understanding the key terms and definitions is essential for all members of research and clinical development teams.
Clinical Trials in the Era of Precision Medicine
Not Like Everyone Else: Unique Challenges for Small & Emerging Biopharma Companies
Small and emerging biopharmas are conducting almost 50% of clinical trials in the U.S., often with lean teams, resources and infrastructure. Learn how to reduce the pressure on teams and timelines.
Innovation in Investigator Site Contracting
Subject Recruitment Materials: Understanding the Requirements for IRB Review
Often, the only way for potential research subjects to learn about a clinical trial is through recruitment materials. But what materials must you submit to the IRB for review?
Clinical Study Sites Struggle to Manage Responses to Ad Campaigns
How Roche Optimized its Global Safety Reporting Process for Clinical Trials