By Michael Wienholt, RAC Recently, we’ve been receiving inquiries from some of our IVD clients about the latest developments with Theranos, Inc. They want to know if Theranos’ troubles indicate a shift in FDA policy toward regulation of IVDs or whether it is merely another indication of FDA enforcement action against CLIA laboratories offering LDTs. […]
Halloran Consulting Group
Choosing the right quality assurance auditor
By Halloran Consulting Group, Inc Read the full post on Halloran’s insights page. You are more than halfway through conducting your pivotal clinical trial when all of a sudden it hits you: something is missing. As you review the study expenses, you realize that the study budget does not have a line item for the […]
FDA releases draft guidance on the request for quality metrics
By Halloran Consulting Group, Inc Read the full post on Halloran’s insights page. The Food and Drug Administration (FDA) released a draft guidance on the Request for Quality Metrics on July 29, 2015 and it is open for comment through September 29, 2015. The following summary provides a simplified review of the draft guidance and […]
Halloran announces Inc. Magazine recognition as one of America’s fastest-growing companies for second year running
By Halloran Consulting Group, Inc Halloran Consulting Group, Inc. (Halloran) has been recognized for the second year in a row by Inc. magazine as one of the fastest-growing private companies in the country, placing on the annual Inc. 5000. Started in 1982, this prestigious list of the nation’s most successful private companies has become the […]
Inverting the clinical trial/physician relationship: The future (and data) is in the practice
By Mark Vermette Traditionally, in the pharmaceutical and biotech worlds, a pharma company finds a candidate product and works with a group of doctors to test that product under careful standards and procedures. If the product shows therapeutic value and safety, it becomes available to prescribers to administer to patients for that purpose. The roles […]
Remote auditing – It’s not all or nothing
By Susan Gould, MBA, MS With the improvement in secure documentation sharing, many auditors are utilizing remote auditing practices to conduct audits. This saves travel time and costs and can be an efficient auditing method. However, this does not mean that all audits should be completed entirely remotely. For example, Good Manufacturing Practices (GMP) and […]
Creating a compliant, lock-tight site budget for clinical trials
By Kathi Shah, MS, MBA
Creating a clinical trial site budget sounds simple right? A Sponsor contracts with an investigative site to conduct a clinical trial per the protocol. The Investigative site is compensated by the Sponsor to conduct the services outlined in the protocol. The relationship between the Sponsor and Investigative site is heavily weighted on the budget developed to compensate sites for their efforts to conduct the study.
FDA gives public access to Global Unique Device Identification Database (GUDID)
By Angela Brown
FDA releases update on 2014-2015 strategic priorities
By Angela Brown
Key Strategies to Staying in Control of Your Study Financial Forecast
By Dyana Boutwell
I know, clinical financial forecasting is everyone’s favorite topic. Don’t hold back your excitement in wanting to think all about your budget management responsibilities. Now is it because you are struggling to keep on top of your study budget? Is your forecast up, down, up again, and you are seeing fire come from the eyes of your Finance rep? I’ve been there. I’ve seen the fire. And I’d like to take this opportunity to give you some key pointers to throwing the bucket of water so all is peas and carrots at the monthly Finance meeting.
Analysis on FDA clarifying stance on accepting clinical trial data conducted OUS
