You have spent time and money developing a compound and selecting a contract research lab to help develop that compound into a marketable therapy. You are now at the point where you have to hand that compound over to the contract research lab and trust they are going to manage those aspects of the IND development. As a Sponsor outsourcing the non-clinical in-vivo research you are entitled to independent monitoring oversight of studies being conducted on your behalf. Your involvement in the critical phases of a nonclinical study is encouraged by regulatory agencies as well.
In the current COVID climate and limited travel – CROs, study monitors and you the Sponsor are missing the collaborative atmosphere that you experienced in person previously during a study. This is problematic for several reasons, one being you have to take the CROs word that everything is going satisfactorily with the study and no problems are popping up. Also, not being present or represented during a critical phase could result in the scientist missing something that is really important based on your prior knowledge of the compound where applicable.
Some CROs are providing internal study monitors, usually senior members of their staff, but that raises the question of conflict of interest. In addition, there are often additional charges associated with the CROs monitoring practice to the study for providing that. We don't think that is the correct way of conducting business, and more importantly, you should not be incurring additional expense for a service that the CRO should already be providing.
Here at Attentive, we invite our Sponsors to stay engaged even during COVID by offering creative methods for continued critical oversight. Through a safe and secure remote video link we provide our Sponsors and auditors (as applicable) the opportunity to oversee the in-life and critical phases of their study. With real time availability of scientific staff conducting the study, permitted access to every stage of a study, enhanced team atmosphere; oversight and accountability from all involved is achieved.
Everyone has been financially affected by COVID enough and we are not going to take advantage of you, but rather provide you the extra support without gouging you the Sponsor. Monitoring your study wasn’t out of the ordinary before COVID and we are trying to make it as normal as possible at no extra cost to you.
Give us a call today or schedule a virtual tour and work with a contract research organization that will continue to adapt to difficult situations and continue to be attentive to the needs of our clients