Navigating the complex landscape of regulatory and ethical requirements is critical for the success of clinical trials. Our Phase I unit is Supported by the expertise, processes, and systems of the Accelsiors Regulatory Department to ensure that every study is conducted in full compliance with local and international standards. From protocol design to final reporting, we prioritize the research’s integrity and participants’ safety while ensuring seamless collaboration with regulatory authorities and ethical committees (ECs).
Providing end-to-end support for protocol development, ethical committee (EC) submissions, and regulatory filings. The Accelsiors team collaborates with Sponsors to design study protocols which meet global regulatory standards, including FDA< EMA, and ICH/GCP guidelines. Our teams manage EC submissions, making sure all study materials, adverts, and informed consent forms (ICFs) are ethically compliant. Furthermore, Accelsiors handles regulatory submissions such as Investigational New Drug (IND) applications, and Clinical Trial Applications (CTAs), making sure our processes are in place for faster trial initiation.
For us at Accelsiors, participant safety and rights are at the very core of what we do, and by extent we take that on towards our compliance processes. Clear and comprehensive ICFs are developed, and we ensure participants are fully educated on study procedures and associated risks before enrollment. Trials are met with the highest ethical and regulatory benchmarks, through the adherence to global standards, such as GCP, 21 CFT Part 11, and GDPR. Thus, protecting participant welfare.
Our proprietary systems ensure real-time monitoring of study activities and adherence to compliance standards. Furthermore, our internal audits and inspections are designated to identify and address any potential gaps, keeping trials on track. Adverse Event (AE) and Serious Adverse Event (SAE) reporting to sponsors, ECs, and regulatory agencies is vigilant and with no delay. To ensure complete transparency and traceability and regulatory readiness, comprehensive documentation and reporting are standard procedure at Accelsiors.
In order to align trial activities with agency expectations, our regulatory specialists liaise with agencies such as the FDA, EMA, and other local health authorities. This proactive approach to regulatory engagement ensures early feedback, it sees the streamlining of review processes, and generally accelerates trial timelines. This close collaboration which we so proudly foster with regulatory agencies, ensures smooth trial progress and remaining compliant every step of the way.
By keeping all stakeholders informed and aligned, we ensure that every aspect of your trial adheres to best practices and the latest guidelines. At Accelsiors we achieve this with no compromise on investing in training and compliance education to clinical staff and sponsors alike on the latest regulatory and ethical requirements, which in return enhances the overall quality and integrity of the study.
Our Regulatory and Ethical Compliance services provide the foundation for trustworthy and successful clinical trials. Committed to precision, transparency, and participant safety, we ensure that your trial meets the highest ethical and regulatory standards at every stage.
Thank you for signing up as a volunteer for our clinical trial. We have received your submission, and a specialized member of our team will be in touch with you within the next few days.
At Accelsiors, we take the protection of your privacy and personal data very seriously. We have implemented all necessary measures to ensure the security and confidentiality of your information. To learn more about how we collect, use, and protect your data, please read our Privacy and Personal Data Protection Policy.
If you have any questions or need further assistance in the meantime, feel free to reach out to us.
Warm regards,
The Accelsiors Team
