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. […]

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 […]

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 […]

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 […]

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 […]