Pearl Pathways is excited to sponsor Q1 Productions’ and attend its upcoming IVD conference on Clinical Affairs and Regulatory Approvals for Diagnostics. The conference provides an excellent opportunity to network with industry experts and gain additional insight on...
In order to present related information to a clinical study and acquire and document informed consent, electronic systems and processes such as text, audio, and graphics are increasingly being employed. According to FDA per their new draft guidance, this is referred...
Conducting clinical research is extremely time consuming given the extensive requirements necessary to begin a clinical trial. Protocols must be adhered to, results must be extensively recorded, and most importantly, patients must be protected complying with Section...
Pearl Pathways’ own, Heidi Strunk, RAC will be presenting at the Indiana Medical Device Manufacturers Council (IMDMC) workshop in Indianapolis, Indiana entitled, A Deep Dive Into Inspection Preparedness. The workshop provides an opportunity to hear from experts who...
Pearl Pathways’ own COO and Co-Founder, Gretchen Bowker will be holding a webinar on FDA regulatory requirements for the manufacturing and commercialization of dietary supplements via ComplianceOnline. A few of the topics include a review of FDA regulations in the...
Pearl Pathways is excited to be attending and presenting at the Annual Clinical Affairs & Regulatory Approvals for Diagnostics Conference next week in Alexandria, VA. This conference provides a forum for discussion on the challenges regulators face and strategies...