The SCIO Concept: How to Conduct Cost-Effective Clinical Trials

For the past 20 years, the cost of new drug  development has risen at a rate  that was 7.4%  higher than inflation, and clinical trials bear...

When Is A CRO Not A CRO? (And why does that make enforcement hard?)

  It looks like a CRO. It sounds like a CRO. But is it really a CRO? by Jamie Colgin Colgin Consulting What do the following types of compan...

CLIA vs QSR (What You Don’t Know Can Hurt You)

The Clinical Laboratory Improvement Amendments (CLIA)established quality standards to ensure the accuracy, reliability, and timeliness of pa...

One Q & a Lotta A’s about SOPs for Research Sites

SOPs or work instructions--- which does a clinical research site need? by Laurie Meehan Social Media Manager Polaris Compliance Consultants,...

Big Changes for ICH GCP & EU Regulations

Changes are being proposed for international  clinical research, including the European Union.   How and when will they affect your work? by...

Inspection Readiness: Leveraging Inspection Focus Areas and Increasing the Transparency of Investigator Oversight

An auditor's goal is to confirm the trial runs  in a way that ensures the safety of the subjects,  protects their rights and generates r...

Holistic CQMS: The Modern Model of Clinical Trial Management

Best clinical quality management practices  can only be achieved when an overarching  culture of quality exists organization-wide. by Jam...

The Patient is Missing

Clinical volunteers can choose to walk away  any time they want and to clinical  trials they may be irreplaceable. by Amy Musolino Program...

Ensuring Proper Training for Clinical Research Staff in Less Time

Many clinical research associates spend as much  as 75 percent of their time on the road.  by Sandra Maddock President & CEO, IMARC Res...

From Open Payments to OpenFDA, the Push for Global Transparency is Accelerating

Transparency leads to happier patients,  better trials and lower costs, advocates say.   by Lisa Weeks, Marketing Communications Specialist,...