Blog
Comprehensive partnerships help medical device research move forward
FDA recommends that partnerships should be used to better monitor medical device performance once released. The article states knee replacements as an example of an area that uses multiple different medical devices, yet the performance information has not been...
New GCP guidelines announced
After nearly twenty years with the current Good Clinical Practice (GCP) guidelines, ICH is publishing an addendum that will change definitions, principles and responsibilities for the future. These changes include new requirements of compliance and risk, many of which...
Researchers are using observational studies on big data to get results
A recent study has shown that the combinations of specific drugs have a positive effect on lowering hypertension for people with high blood pressure. Using big data, researchers have been able to identify unknown effects of specific drugs. This creates a quicker and...
NPRM released outlines changes to Common Rule
A Notice of Proposed Rulemaking (NPRM) released 8 Sep 2015 outlines revisions to the Common Rule (45 CFR 46 subpart A) meant to modernize, strengthen, and make it more effective. The most significant changes to the Common Rule proposed in the NPRM are as follows:...
Welcome Mary Anne Gfell to Pearl Pathways
Pearl Pathways is excited to announce the addition of Mary Anne Gfell to the team as a Clinical Research Advisor. Bringing over 15 years of experience in clinical research and quality compliance, Gfell is a key addition to the Pearl Pathways team. Prior to joining...