News & Events Transitioning Investigator Studies to Corporate Sponsored Studies

Transitioning Investigator Studies to Corporate Sponsored Studies

November 29, 2019

Recently, there has been an increase in cutting-edge technologies in cell and gene therapies being developed in academic universities. The academic institutions serve as incubators of promising technologies, with corporate sponsors entering later to provide the financial backing and drug development expertise to move the product through to regulatory approval.

The model can be an efficient method to address the gaps in rare diseases and indications with high unmet needs. However, the transition of these studies from academic institution to corporate sponsorship is not always easy or straightforward. Below are some topics to consider when coordinating the transition of your study from an academic institution to corporate sponsorship.

Data Migration
Arguably the most important factor to consider during the transition process is the migration of data collected by the academic institution to the corporate sponsor. Sometimes this process involves manual entry of paper CRFs to the EDC. Sometimes it involves coordinating between multiple departments at the academic institution (and sometimes other hospitals). Sometimes it requires double-data entry to avoid human error. It is important to proactively assess the state of the data at the academic institution at the beginning of the process so both the CRO and the academic site can accurately scope the amount of work it will take to transition the data. 
Regulatory Transitions
Another important variable of the transition process is transferring the IND and other necessary regulatory documents from the academic institution to the sponsor. Close collaboration between all involved parties and an attention to detail are necessary for the successful completion of this task.

It is particularly important for newer or smaller companies to choose a CRO with experience managing all of the small details involved in transferring an IND from an investigator to a corporate sponsor.
Relationship Management
The academic institution that initially developed the technology being purchased by the corporate sponsor is a crucial partner, not only for the program at hand but for future programs in the space. It is critical to maintain and foster the relationship between the sponsor and the site. However, at times it can be difficult to navigate conflicting needs and opinions. It is important to choose a CRO who can communicate effectively and has experience managing the concerns of both the site and the sponsor. 
How CTI Can Help
CTI understands the challenges in these transitions. We have successfully transitioned many studies from academic investigator-initiated to corporate-sponsored programs. We have navigated the regulatory, clinical operations and data management hurdles that seem inherent in these transitions. And we have made these transitions while maintaining the delicate relationships that often exist between the academic innovator and the new corporate sponsor.

If your company or institution is about to enter a transition stage like this, CTI would be well-positioned to assist.

To find out more about our expertise and how we can help you with running your clinical program, visit our website or fill out our contact form to start a conversation with one of our team members.
 

The Year of the Employee

Every month, we'll be spotlighting one of our employees and their contributions to CTI. We are successful as a company because of our passionate and talented employees, who work tirelessly to bring life-changing drugs to patients around the world.

Rachael Gilbert Runyan
Manager, Biostatistics
Rachael joined CTI in 2013 as a Biostatistician I, quickly progressing to her current role as Manager, Biostatistics.  She is one of the leading CDISC experts in the Biostatistics department, and takes on the responsibility of developing processes and training for the team.
 In addition to her project-specific work, Rachael also spends a portion of her time mentoring and assisting junior members of the team.  
 
Want to join Rachael and our CTI team? Click to see our current job opportunities, including new expansion across the United States!
 

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