Investigative Sites

Award for excellence in human research protection is the incentive for better oversight and regulations.

How text messaging could revolutionize clinical trial subject recruitment and compliance.

In the age of international trials, data drives the selection of golden sites and investigators to get it right.

Carl Anderson, senior consultant for Biologics Consulting Group, addresses the frequent overuse of Notes to File and concludes that documenting a mistake means absolutely nothing during an FDA inspection.

Effective contingency planning requires implementing small but critical seeds at the outset of a study.

Dan McDonald, vice president of business development for Excel Life Sciences, assesses the role of Site Management Organizations (SMOs) in India and discusses their contributions, which include GCP training and assistance for investigators.

Pharma and CROs must update their infrastructures to handle the increasing use of imaging in trials.

Both parties benefit from intentional friendships, and nowadays CRAs are key to this cordial effort.

Structuring the knowledge and expertise within the organization is key to a project plan that works.

Industry must grasp the cultural nuances of these two burgeoning countries to find success there.

Matt Kibby, leader of global operations for BBK Worldwide, discusses why country study managers hold the key to global enrollment success but are afraid to use it.

How imaging CROs minimize data variability in multisite studies and create the necessary consistency.

Perceptive Informatics Improves the Clinical Development Process with Enhanced CTMS Technology

Data confirms more sites are asking for separate startup fees and that oncology trials are leading the way.

To improve enrollment in oncology trials, one patient advocate group went straight to the source.

Today's CRAs must redefine their roles in the face of changing industry expectations and new technologies.

How a good plan and hot lunch can spell success for sponsors. Attention to detail can help boost dwindling subject enrollment and retention, saving both time and money.

In addition to study timelines and budgets, EDC adoption directly affects the people who run trials.

India's investigators play a key role in helping CROs & sponsors recruit patients and meet global standards.

A new patient recruitment campaign depicts trial volunteers as heroes and aims to both educate and win over the public.

Applying supply chain management principles to clinical development can save sponsors money and time.

EHR has the potential to help solve long-time clinical trial recruitment, cost, and safety challenges.

India continues to gain the attention of pharmaceutical companies looking for a place to conduct clinical trials because of the country's reputation for fast subject recruitment rates. But as Jane Barrett reveals, sometimes the country's clinical trial participants are more uninformed than informed.

The importance of human subject protection, clear communication, and community spirit are among the issues emerging from the tragedy.

Yesterday's SMOs have given way to a new service provider that should be recognized.