Investigative Sites

Today's problem-plagued feasibility assessment process is in need of repair.

Just like pharma, biotech companies need clinical research organizations too, but are their needs different?

Why this age-old industry staple is missing the mark for many and what can be done to remedy the situation.

A call to sponsors to rethink the role of ECGs in drug development and the use of central core labs.

Pilot test to rebrand clinical research shows promise as a way to build public trust and promote interest.

According to results from a recent survey, clinical research is poised for the eClinical journey ahead.

The decision to outsource must also consider not so obvious issues that are as critical as cost.

Today's CROs need to provide expertise on a global scale.

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

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.