Category Archives: Uncategorized

Protocols & Clinical Processes

I have much experience with protocol development and my protocols have achieved successful registration of products.  I write protocols not only by having the therapeutic knowledge base in many cases but also by engaging  KOLs to understand their practices and processes as well as including statisticians to ensure we power accurately and who also know about protocol design.   Successful studies require understanding of site practice also.  Regulations must be met with site practices in mind to keep deviations to a minimum and site engagement to a maximum.

Starting out with feasibility also helps if a therapy area I have not worked with before. I am a natural researcher and so review prior product approvals to understand what has been done before and not reinventing it;but rather improving it!

I spent a lot of time mentoring CRAs and I enjoy training. Successful protocols are one perspective of a successful trial but the other is well trained monitors who know what to look for and how to handle data at the site level. I enjoy mentoring and trainining CRAs. I am processes person. I have created and reviewed so many key study documents that ensure we capture what we need for compliance; IMP Manuals and Logs, Source Document Worksheets, Study Operational Manuals to name a few that should always be study specific and never generic if compliance is the goal.

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 the role to get a study started up and ongoing managing all the CRO timeline and document preparation to ensure the Sponsor goal is met. 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 Sponsorside 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 operations with the experience and background.

CRO Selection Services

I am requested to help Sponsors to select CROs quite often and I take this role very seriously and approach it with honesty and integrity.  Being independent is key. In full disclosure I not accept commissions or rewards from any CRO for winning them a contract.   I chose it to be this way so I can independently assess which one is best for you.  I have many tools I have created to shortlist CROs for a Sponsor trying to find a good fit for them. Having founded and managed a CRO for over 10 years as well as managing and selecting CROs for 5 years during my tenure with Omrix, I am well equipped to compare CRO bids, understand how they work and create RFIs and RFPS that meet the needs of the study. I know how to evaluate and compare and help you select the ideal CRO for your company. I have a scoring system that is weighted to your needs to help you select the CRO based on what is important to you the Sponsor. I can guide and advise but the ultimate choice armed with the facts and an independent review is who you feel at ease with.