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Medical Device » Working with Asentral:
We realize that Medical Device designers and manufacturers face a different set of challenges in their approach to gaining federal and state approvals of their new products or their new indications than do the BioTech/Pharma industries. Asentral, Inc. IRB has extensive experience in working with Medical Device studies and helping organizations navigate through the design of a safe research study. We are a member of the Medical Development Group (http://www.meddevgroup.org/).
Some advantages of working with Asentral include:
- Ready access to IRB agendas. The Board meets weekly. Completed submissions received at Asentral by Thursday at noon will be reviewed at the following week’s IRB meeting.
- Fast turnaround times. Information relative to your study will be made available to you and your study sites on the next day immediately following the IRB meeting. If there are questions or concerns to be addressed, you will have them the day after the IRB meeting. IRB approvals will be sent to you electronically as well as by regular mail such that there is no delay in starting your study.
- We work in a collegial manner with Principal Investigators, sites, Sponsors, and CROs to resolve issues that affect the safety and welfare of study subjects.
- We provide training programs on Good Clinical Practices, Audit Preparation, history of clinical research, and the process of Informed Consent. We will also customize a training session to fit your needs.
- Personalized, professional communication. Our staff members are either principals in the company or long-standing professionals who will know who you are and what your study is about when you call. The staff also attends the IRB meetings so they have first-hand information to address your questions.