Sarah Steinmetz, Director Study Operations

Recent Posts

WuXi AppTec Now Offers Dual Route Subchronic Toxicity Test

Posted by Sarah Steinmetz, Director Study Operations on August 21, 2018

For your medical device study designs and protocols, our scientists build in the most effective in-vivo or in-vitro model to meet the study goals and stay compliant with governing laws, including the Animal Welfare Act (AWA) when applicable.

At an international level, ISO 10993 working groups, including participants from WuXi AppTec, are challenged to find alternatives to existing in-vivo models as well as ways to meet study endpoints in new and creative ways to reduce current requirements. At the same time, these working groups must ensure that any alternative model or reduction in requirements does not impact the scientific outcomes of the study or, at a minimum, demonstrates equivalency.

Read More

Topics: Medical Device, Biological Safety Testing, biocompatibility, Technical Expertise, Regulatory Expertise

Scientific Principles in Practice: Study Directors’ Participation is Vital for Good Laboratory Practices

Posted by Sarah Steinmetz, Director Study Operations on August 07, 2018

WuXi AppTec Laboratory Testing Division Medical Device complies with Good Laboratory Practices (GLP) that meet the latest FDA GLP regulations and OECD test guidelines and expectations. Studies that run compliant with GLP principles require a Study Director—a key role in ensuring a study’s success.

The Organisation for Economic Co-operation and Development (OECD) defines the role of the Study Director, as “…the single point of study control with ultimate responsibility for the overall scientific conduct of the study.”

Read More

Topics: Medical Device, Technical Expertise, Regulatory Expertise