1We are already working with an expert in our field, can we bring our own operator?
Absolutely. The SCI process is designed to fit the sponsor’s needs, including the sponsor’s preferred KOLs. We welcome the opportunity.
2How much flexibility do we have in study design and execution?
Every novel technology presents unique opportunities in terms of strategy and investigation methods. The SCI team will make recommendations based on experience and expertise in terms of what questions can be answered using models, how the model data will translate to the human experience, and how regulatory agencies have viewed data on similar technologies. Recognizing the sponsor is best informed on its own product, SCI works with the sponsor to develop a customized strategy and study design
3My program is very early and in the exploratory stage. Is it possible to do just small feasibility work?
Yes, SCI’s depth of experience in product development and knowledge of current standards of practice in the clinic, allow the team to support the sponsor through early feasibility, regardless of study size.
4If I wanted a consultation on readiness for a human trial, how could I get that?
Consultations with CRF’s CTC can be arranged anywhere in the process of preclinical study design from initial study design to review and interpretation of data.
5My device is fully developed and in clinical trial, what are the advantages of using SCI for training?
SCI and CRF have experience in the development of training programs for complex procedures using diverse set of training methods. As part of one of the premier physician training organizations world-wide, SCI is well prepared to provide a program structured to sponsor’s needs regardless of size, and the sponsor can use the training to highlight the key aspects of using new technologies to physicians.
6Will SCI publish results of my study?
The sponsor owns the data from any study performed at SCI, and no data from any study is published without sponsor permission. SCI is well accomplished in developing materials for publication, and can provide an independent voice to results, however, will not publish any data without permission and review from the sponsor.