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...

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...

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...

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 “...

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...