March 24th 2025
Survey from the Site Council gathered insights from its members on the quality of site coordinator work.
March 14th 2025
Addressing data integrity and compliance concerns.
March 11th 2025
This year’s conference highlighted a number of critical areas in clinical R&D including financial management, representation, and eCOA.
February 11th 2025
Examining those technology-supported areas that sponsors, CROs, and sites consider the most valuable.
February 10th 2025
Insights identify opportunities to optimize sponsor, CRO, and site collaborations.
Applying the Supply Chain Model
Can processes used for 20 years in the manufacturing and retail industries work for us too?
The Changing Core Laboratory
How one lab is using continuous process improvement to decrease timelines and redefine itself.
Burying Sites Under Safety Reporting
A look at the vague but time consuming requirements imposed on sites and efforts to ease the burden.
Global Trials
As patient recruiters and sponsors face low recruitment numbers, they must look beyond global trials to find a solution.
The Changing Role of Data Services Project Managers
DSPMs offer a new skill set to drive data-heavy clinical trials and meet the needs of an evolving landscape.
Work-Life Notes from a Large CRO
A look into the work-life benefits that are offered at a large contract research organization.
Work-Life Notes from a Small CRO
A look into the work-life benefits that are offered at a small contract research organization.
Welcome to the 21st Century
The need for collaboration between the various disciplines and stakeholders is becoming crucial.
The Changing Role of CRAs
As CRO business and operational models change, so do the opportunities for CRAs.
India's Talent Crunch
A look into the country's job market today and what's driving many employees to company hop.
Communication Redefined
How the Web revolutionizes sharing and learning for clinical trial professionals.
R&D In a Virtual World
A purely empirical approach to drug development may allow for evaluation of the overt factors that impact the balance of benefit and risk, but it will never uncover all potential scenarios for which companies are now being held accountable.
Developing a Regulatory Strategy
By defining hurdles to registration, emerging companies benefit from early regulatory guidance.
Getting to the Heart of Public Distrust
The public considers clinical research important, but they're not fans of the people behind it.
Outsourcing's Evolution from Commodity to Partner
Can the historical industry and vendor service relationship change to one where both parties benefit?
Steps to Functional Service Provider Success
Outsourcing fundamentals for this pick-and-choose model so that both sponsors and service providers win.
How We Fail to Use CROs Effectively
Productive relationships with CROs require a well thought out strategy on the part of sponsors.
Preapproval Opportunities
Integrating clinical trials and named patient programs to provide global access to drugs before approval.
Make Room for Change
Norbert Clemens, MD, head of clinical development for CRS Clinical Research Services, explains that EDC is more than just technology; it is indeed the new way of thinking about clinical research.
The Face of Partnering in India
How leveraging local expertise can make the migration east smoother for companies.
Pharma Casts Out Financial Functions
Outsourcing finance and accounting can provide cost savings and improve operations.
Key Factors in CRO Selection
A recent survey uncovers key criteria that influence a sponsor's decision when selecting a CRO.
In Search of Efficiency Between Trial Phases
Today's sponsors are waking up to the fact that changes made between phases can positively impact R&D.
How Technology Could Change Drug Approvals
Peek into a future where drugs are approved faster and R&D is less costly thanks to technology.
Preferred Providers Face Outsourcing Challenges
Performance and noncompliance clauses change the partnership between sponsor and vendor.
Responses to NEJM Article
Readers respond to the NEJM article mentioned in November's From the Editor
Centralizing the Laboratory
Strategies for labs to support global trials and meet the needs of sponsors worldwide.
Early Accuracy in New Drug Safety Analysis
A look at ECG evaluation for drug-related alterations in repolarization and Torsade de Pointes.
Elements of a Successful Platform for Image Analysis
To select the right CRO as an imaging partner, sponsors must first be aware of what to look for.
The Local Central Lab Model
With globalization of trials comes the difficulties of biologic sample logistics. Enter the centralized/decentralized laboratory model.