CRO Selection
I am often requested to help Sponsors in selecting CROs, and I take this role very seriously, approaching it with honesty and integrity. Being independent is key. In full disclosure, I do not accept commissions or rewards from any CRO I recommend for contract award. Moreover, I have created many tools used to shortlist CROs during the bidding process that ensure compatibility with the both the sponsor and the project. Having founded and managed a CRO for over 10 years, as well as managing and selecting CROs during my tenure with Omrix, I am well equipped to compare CRO bids, understand how they work, and create RFIs and RFPs that illicit the essential aspects of competitive bids. I also use a scoring system that is weighted to your needs to help in selecting the CRO based on what is most important to you.
CRO Management
I act as the Sponsor’s Clinical Arm. Often in the early stages of a company’s development, there is no clinical operations team. I take on that role fully in order to initiation your studies, simultaneously managing CROs, timelines, and document preparation. I review and create documents on behalf of the Sponsor and manage the budget as if it were my own. I believe in performance-based success. I understand the CRO limitations and the need for them to have someone on the Sponsor’s side to sign off on key documents and direct them. I also understand what the Sponsor’s goal is. With this unique skillset, I am the ideal person to manage this relationship whilst having the expertise to manage the various operational processes with experience and know-how.