The branch of our regulatory team responsible for ethics committee & review board submissions ensures that each document concerning the clinical trial is timely submitted to the respective review board. To facilitate the approach of stringent timelines and enhanced processes for even the most complex clinical trials, we must stay ahead of regulatory changes and maintain a strong commitment to research excellence.
Proactive & Flexible Regulatory Solutions Adapting to your Clinical Trial
We aim to free your team from the complicated processes of regulatory submissions so that you could focus more on delivering valuable products to the market. Deciphering regulatory requirements, validating study expectations, and meticulously preparing regulatory documents ensures that we always remain compliant and proficient with regulations.
— Our Capabilities
Compilation & Submissions of All Regulatory Documents — No Matter How Complex The Clinical Trial
Minerva’s regulatory team is responsible for filling out all the study-related documents that are delivered to the sponsors before they are further sent to the respective IRB or review boards for approval of each study. We provide regulatory expertise to facilitate approvals from ethics committees and review boards for phase I to IV clinical trials, be it for non-interventional studies, or observational studies.
Our regulatory team is adept in the development and review of important regulatory documents and we excel at developing regulatory submission strategies that yield optimal results and accelerate your study startup timelines. Using real-world expertise & insights, we aim to meet your regulatory needs and accelerate approvals.
What We Do?
Delivering Value Through Data-driven Approach & Stringent Timelines
Deploy Minerva’s trusted regulatory resources while you do what you do best — innovate. Our regulatory experts will handle all the compiling, publishing, and submitting of important documents to the respected ethics committees and review boards. Reduce costs, and scale quickly by utilizing our highly skilled, and knowledgeable professionals.
Defined Regulatory Submissions Strategy
Authoring or Reviewing Submission Documents
Constant IRB Correspondence
Amongst fulfilling other regulatory needs, Minerva’s regulatory team is responsible for preparing documents that will be signed by the PIs and all the signed documents would then be routed to IRB for the submission’s approval.
Minerva Research Solutions is based in Michigan and Texas. If you would like to work with us, please contact us.
We compile and prepare FDA-1572, Financial Disclosure Forms, Site Contact Forms, Recruitment Materials, Lab & Pharmacy Manuals, and Study Materials before submitting them to the IRB for approval. As per the regulatory board’s ever-changing rules and the study, we develop documents that may be required.