Regulatory Support Services
Our Unrivaled Expertise in Regulatory Services for Clinical Trials.
At YouV, we bring decades of regulatory expertise to ensure your clinical trials run smoothly and efficiently. Our dedicated regulatory teams provide tailored solutions that streamline the approval process and maintain compliance with global standards.
Accelerating Regulatory Submissions with Precision and Compliance
We specialize in expediting regulatory submissions by leveraging the latest eRegulatory technologies, ensuring fast and secure communication with global regulatory authorities and IRBs. Our processes adhere to the highest compliance standards, minimizing delays and maximizing trial success.
A Comprehensive Suite of Regulatory Services Tailored to Your Needs
From study start-up to post-market reporting, our regulatory services cover every aspect of the trial lifecycle. Our team stays ahead of evolving regulations to provide proactive guidance, ensuring your study stays on track and compliant.
Certified and Experienced in Global Regulatory Requirements
We are highly experienced in navigating complex regulatory landscapes across multiple regions. Our experts excel in managing submissions through systems such as eISF, CTMS, and IRB platforms, offering unmatched expertise in regulatory compliance and global trial management.
Tailored FSP Models for Regulatory Support Services.
At YouV, we understand that every clinical trial has unique requirements, which is why we offer a flexible array of FSP models that can be adapted to your specific needs. Our regulatory support services encompass a comprehensive range of activities designed to help organizations comply with various international and national laws and regulations. These services vary depending on the type of investigational product and the specific regulatory requirements applicable to your study. Below are the different models we offer for regulatory support:
Fixed-Price Model
A set fee for a defined scope of regulatory services.
Unitized Pricing Model
Charges based on units of work completed (e.g., per document or submission).
Output/Performance-Based
Payment tied to specific outcomes or regulatory milestones.
FTE-Based Model
Allocates dedicated regulatory experts based on Full-Time Equivalent (FTE) structure.
Time & Materials (T&M)
Pay for the actual time and resources spent, based on hourly or daily rates.
Our Regulatory Services in Nutshell:
- Prepare, quality check and submit regulatory documents/packages to the Sponsor, IRB/IEC/EC and Data safety boards or equivalent committees, as applicable
- Collaborate with the clinical research team to ensure submission materials are current and compliant with regulations.
- Maintain regulatory documentation, including consent forms, protocols, 1572s or equivalent, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms (and translations, when applicable)
- Oversee study start-up activities, including regular reporting and communication with stakeholders, prior to the release of the first shipment of IP to investigational sites.
- Monitor the approval status of open studies by conducting timely reviews.
- Offer guidance and training to investigational site research staff to ensure compliance with regulations.
- Stays up-to-date with federal, state, and institutional guidelines related to clinical trials.
- Continued guidance and training research staff to ensure compliance with regulations governing clinical research studies and any applicable amendments.
- Act as a liaison between Sponsors, CRO, IRB, and Investigators, ensuring continuity of service and prompt resolution of issues.
- Maintain master files of all regulatory-related documents/sections.
- Assist in the submission of amendments to approved documents and required reporting.
- Ensure proper closure and compliance with all relevant guidelines prior to site closeouts
- Final Reporting: Prepare and submit final study reports to regulatory authorities, including summarizing the study’s findings, safety data, and any deviations from the protocol
- Regulatory Submissions: Complete and submit all necessary documents for study closure, such as final safety reports, clinical study reports, and any required notifications to ethics committees or institutional review boards (IRBs).
- Data Archiving: Ensure all study data, including patient records and regulatory documents, are archived according to regulatory requirements, employing secure storage systems for long-term data retention.
- Audit Preparation: Prepare for potential audits by regulatory bodies, including organizing all study documentation, ensuring all records are complete and accurate, and addressing any outstanding issues.
- Regulatory Communication: Communicate with regulatory authorities to confirm the study’s closure and address any follow-up questions or requirements.
- Publication Support: Assist with the preparation and submission of study results for publication in scientific journals, to ensure that all regulatory requirements for transparency and reporting comply.
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