A medical device manufacturer conducted a successful randomized IDE clinical trial, but at the time of study closure they decided not to file the Premarket Approval (PMA) application for business reasons. However, five years later, the business climate had improved and the company proceeded with its PMA application.

At Labcorp, we strive to be more than just a partner. Our robust knowledge of mobile healthcare includes over 10 years of experience in providing in-home services, site support and central pharmacy solutions that are solely dedicated to the support of clinical trials.

All governments are keen to ensure that the chemicals produced, manufactured and used within their countries are safe for consumers and used appropriately. The 2007 European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation has become a model globally and is hazard based. In contrast, the U.S.

Inhalation studies are mandatory in many regulatory situations where it is critical to understand the potential risk posed by respiratory exposure to a chemical or agrochemical. As you prepare for the preliminary characterization trials required by regulators, read our answers to 20 frequently asked questions.

Your mission is to transform oncology patient care. Our mission is to help you do it better, faster and more efficiently. Learn more about how Labcorp Oncology can help in your development from initial discovery to post-marketing and commercialization.

Drug development sponsors often seek the support of a clinical research organization (CRO), but today's partnerships depend on more than capabilities. Sponsors need to ensure that the CRO can align with their culture and values throughout the development process and work collaboratively with their existing partners.

SOT 2019 -- Brian and Paul explore advanced therapies definitions, preclinical study and regulatory safety considerations, analytical design and validation strategies, biodistribution studies and data integrity, titre assays, CMC considerations and phase-appropriate validations for preclinical cell and gene therapies.

Welcome to the March Labcorp Drug Development Decentralized Clinical Trial (DCT) blog. This month, we will touch on a few things that all have a common theme: the expansion of DCTs into new therapeutic areas, trial phases and geographies.

Respiratory exposure to chemicals or agrochemicals poses potential risk to human health, especially to workers handling these products. Whether preparing a solution, dusting or spraying crops, or cleaning equipment, opportunities for inadvertent inhalation is a risk that can potentially lead to toxic effects, both acute and chronic.

Regulators across the world are concerned with ensuring that any residues left in or on a crop after application of a plant protection product (PPP), present minimal risk to the health of humans and animals.