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Re: Rollgard1 post# 2979

Saturday, 07/31/2021 9:38:27 AM

Saturday, July 31, 2021 9:38:27 AM

Post# of 4237
A CRO will be running the trial, but ADMP is still calling the shots and is overall in charge. ADMP picks the primary and secondary endpoints as well as gives blessings to any “recommendations” that the CRO may come up with based on their experience. Yes, it does keep ADMP from screwing things up, or from letting ADMP manipulate the statistics to meet their primary and/or secondary endpoints…but make no mistake, ADMP is the sponsor and is calling the shots. Having a non-biased CRO doing the work is a huge benefit as is having the independent Data Safety Monitoring Board. As the DSMB will keep ADMP from crossing any unethical or safety barriers while they try to meet their endpoints.

What the best part is about all of this is ….most of the legwork was already completed by the National Institute of Health. All ADMP has to do is prove the science that was already demonstrated by the NIH.

Should be a “No-Brainer”!

Goooooooo CRO, Gooooooooo ADMP!

A CRO (Contract Research Organization) is a company that provides clinical trial management services for the pharmaceutical, biotech, and medical device industries.
Although there are different types of CROs and diverse levels of specialization (distinct therapeutic areas for instance), typical CRO services include regulatory affairs, site selection and activation, recruitment support, clinical monitoring, data management, trial logistics, pharmacovigilance, biostatistics, medical writing, and project management, among others.
In a clinical trial, CROs are hired by sponsors to perform a set of tasks, taking various technical and administrative responsibilities on the sponsor’s behalf.
The main role of the CRO is to plan, coordinate, execute, and supervise the processes involved in the development of a clinical trial, being a central contact point between the sponsor and other trial actors (e.g. ethics committees, regulatory agencies, vendors, and hospitals).
CROs are key players in clinical research, since they have the knowledge and the capabilities needed for the proper development of a clinical study. They help sponsors by reducing their workload, while ensuring trial quality and compliance with national and international standards.
At the same time, many CROs supply innovative technological tools to increase efficiency in the study processes, which translates into cost reductions.
Without doubt, CROs play a crucial role in the success of a clinical trial. Sponsors should carefully assess the particular needs of their projects, and look for the CRO that best meets their technical requirements and budget.

In My Own Personal Opinion Of Course!

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