We understand that maintaining the highest standards of quality and compliance is paramount to the success of your research projects, especially as you navigate the complexities of clinical trial legislation. Our dedicated QA services team ensures the highest ethical standards of quality and compliance are maintained through our robust internal quality management system.
Our proactive and collaborative approach enables us to ensure:
- Adherence to Good Clinical and Pharmacovigilance Practice (GCP and GPvP) standards in everything we do
- Prioritization of participants’ safety and well-being
- Efficient and effective delivery of high-quality research data
Our expertise encompasses:
- Rigorous audit management of our internal processes and qualification of our trusted vendors to uphold the highest standards.
- Oversight and maintenance of a robust Quality Management System (QMS) that ensures all Evestia Clinical services are delivered to the highest standards and in compliance with regulations.
- Ensuring the quality and compliance of processes across all departments, including Clinical Development and Pharmacovigilance.
- Utilizing the well-known and validated platform TrackWise®, a gold standard benchmark in quality systems management.
- Supporting regulatory adherence through well-developed processes for identifying, managing, and resolving quality events in collaboration with relevant functional teams.
- We recognize that many biotech clients, particularly smaller or less experienced organizations, benefit from clear guidance on navigating the relevant regulations. Our approach is designed to support your journey, plugging any knowledge gaps and ensuring a smooth path toward your goals.
While our work often operates unseen in the background, you can trust our commitment to a culture of quality that extends throughout the organization. To deliver the highest standards, our QA team collaborates closely with study teams to ensure the success of every stage of your clinical program. Our goal is to provide you with the assurance and confidence that your clinical trials are being conducted with the utmost rigor and attention to detail.