- ABOUT US
- PHARMA & BIOTECH
- MEDICAL DEVICE
- RESEARCH SUBJECTS
- CONTACT US
Pharma & Biotech » Working with Asentral
We understand the importance of timing in the development of a new drug. We offer the following features of working with Asentral, Inc. IRB that simplify the process of securing IRB review:
- Ready access to IRB meeting agendas. In most cases, when a complete protocol submission is received before Thursday at noon, it will be reviewed at the following Tuesday IRB meeting.
- Simple application forms. As an IRB, we know the information that we need to gather and we do not believe in putting our clients through unnecessary paperwork exercises. All of our forms can be filled out on-line from our website and either submitted electronically or printed out and mailed.
- Fast turnaround times. You will know the decision of the Board on the next day after the Board meeting. If there are unresolved questions or concerns, you will find an email in your inbox the day after the meeting for you to address. If there is no further information that needs to be gathered as a result of the IRB review, IRB decision documents will be processed and sent out electronically usually within 24 hours of the IRB meeting with hard copies mailed shortly thereafter.
- Concise, knowledgeable communication. The staff at Asentral is primarily comprised of principals in the company and long-term staff professionals. When you call with a question, you will speak with a staff professional that not only knows you but also knows your question or issue. The designated IRB staff member for your study will have attended the IRB meeting where your study is reviewed and will have first-hand information.
Asentral works closely with Investigators, CROs and Sponsors to fully understand a submitted study. If there are issues that the Board takes exception with, they will identify them and usually give the researchers the opportunity to make revisions. In addition, we often include invitations to researchers to address the Board either in person or via teleconference at IRB meetings when that individual’s input is important to the Board’s complete understanding.