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...

Study Sites: Too Many Vendors, Too Little Time

Clinical site employees are dealing with  more tech vendors than ever before,  consuming  time that should be spent  running the study,  wor...

Leveraging Quality Management Systems to Visualize and Mitigate Risk at a Cross-Enterprise Level

Learn to use a quality management system at a  cross-enterprise level during the Proactive  GCP Compliance Conference MasterControl Expert A...

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,...

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...

eTMF Management: Don’t Settle for a One-Trick Pony!

When you search for an electronic  master file (eTMF)  solution, be sure it  is versatile and not a one-trick pony! by Patricia Santos-Serra...

Inspecting Clinical Trials - MHRA on the Trial Master File

Does your trial master file (TMF) look  like this?  It doesn't have to if you  move to an electronic system. by Gail Francis Expert Ins...

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...

Change in Pharmaceutical Manufacture

Change, planned or unplanned,  is imperative in pharma manufacturing. by Peter Murray,  C onsultant 1. The concept of change Within the phar...

How to Tip Off a GCP Auditor in 25 Words or Less

"Jane, quick!  The auditor's here!  What's an SOP?" by Laurie Meehan Social Media Manager Polaris Compliance Consultants “...

Fewer Donor Hearts Used

A new study tracked a pronounced decline in the  use of donor hearts overall in the United States. by Sheila Yu dailyRx News As the waiting...

Regulatory Tools Go UFO: Useful, Free & Online

How do you keep track of the  free regulatory tools you use? by Laurie Meehan Social Media Manager, Polaris Compliance Consultants, Inc. Des...

Data Integrity Starts With User Access

User access to databases can impact data  integrity and get you in trouble with FDA. by Jamie Colgin Colgin Consulting Reprinted with permis...

CAPA Should Not Be a Dreaded Four-Letter Word

A poorly maintained paper-based CAPA  process may contribute to FDA violations. by Cindy Fazzi Editor, MasterControl Insider In a regulated ...

Risk Management in Clinical Research: Process and Application

One aspect of quality involves how risks are approached  and managed throughout the course of a clinical trial by Emily Haglund Clinical Aud...

What Does Risk-Based Monitoring Mean for QA Auditing?

What does risk-based monitoring mean for quality  assurance teams who audit clinical studies? by Laurie Meehan I nternal Project Manager, Po...