• Data exchange can be one of the biggest challenges impacting relationships between CROs and sponsors. How does your company overcome this issue and what standards of practice can be followed to mitigate issues?

 

We believe that scientific interpretation and responsible usage of the data are the keys to a successful data sharing practice in the health care industry. The ultimate goals of the CROs and the sponsors need to be aligned. Our ultimate goal is to help people (sometimes animals too) live longer, happier, and more productive lives. We must share this common goal before we can share our data.

 

• The global healthcare contract research outsourcing market is expected to grow at an annual rate of 6.8% from 2017 to 2025. This market growth is due to increased product pipelines and optimization as well as the growing complexity of regulatory procedures. How does your company’s services and solutions assist in the regulatory process and how does your company prepare for the ever-changing regulatory landscape?

 

One of the drug development trends is the rapid growth of the development of biosimilar drugs. This trend is fueled by the need of low-cost yet safe and efficacious biological drugs. The regulatory agencies around the world are establishing new regulations on the biosimilar drugs to protect patients and guide the drug makers. Our company, Rapid Novor, is a leader in antibody de novo sequencing using mass spectrometry. Our service helps the biosimilar drug developers understand the reference antibody drugs better and/or improve the Quality Assurance (QA) of the biosimilar candidates to meet the regulations at the early stage.