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FDA Releases Draft Guidance on Use of Electronic Information Consent in Clinical Studies

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 According to FDA per their new draft guidance, this is referred...

Complying with clinical trial requirements takes 23 million hours per year

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...

Chad Pannucci joins Pearl Pathways as new Business Development Director

Pearl Pathways is excited to announce the hiring of Chad Pannucci as the new Business Development Director. Pannucci will be responsible for driving overall business development and sales of professional services within Pearl Pathways three business units including...

Heidi Strunk to present on Inspection Readiness at IMDMC workshop on April 15th

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 IRB’s uniqueness further distinguished with AAHRPP Accreditation

Pearl IRB joins an elite group of 23 commercial-independent IRBS’s and becomes just the second AAHRPP accredited organization in the state of Indiana by demonstrating high standards of excellence for quality, ethics, and protection in all levels of research. Pearl...
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Single IRB – A Guide to the Common Rule sIRB Mandate

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Pearl Pathways is a comprehensive life science product development services company. Every day we strive to provide our customers top quality service, unyielding ethics, and efficient services through our team of experts. Pearl Pathways supports biopharmaceutical, medical device, and diagnostic companies as well as life science service providers with clinical, regulatory, and quality compliance needs. Our full-service central IRB supports all aspects of human research.

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