Welcome to the realm of GCP audits with a twist of ICH GCP E6(R2) and ISO 14155:2020. We know audits can sound intimidating, but don’t worry, we’re here to make it exciting!
Our customizable offer
Our mission is to ensure your clinical studies are shipshape and compliant with the applicable regulations and laws. We’ve got your back from start to finish! From routine to for-cause audits, we’ve got a flavor for every need. We’ll tailor the audit to your specific requirements. palleos healthcare is not about one-size-fits-all. Your audit, your way! We’ll customize our approach to meet your specific needs. Think of us as your personal audit tailors.
Our principles are transparency, objectivity, and thoroughness. We’ll leave no stone unturned to ensure your compliance. Last but not least, we won’t just audit you; we’ll help you improve! The PDCA cycle is our guiding star. We’ll help you plan, implement, check, and take action for continuous improvement.
Whether it’s pharma or biotech, we’ve got the know-how to keep your medicinal products on the right track. Compliance isn’t just our specialty; it’s our commitment.
You focus on devices? No problem! We possess an in-depth understanding of the details of the medical device realm. We are well-acquainted with the latest standards and will ensure your studies align seamlessly with them, leaving no room for compromise.
In our meticulous audits, ensuring the safety of patients is an unshakable commitment. We delve deep into the measures in place to protect the well-being of those participating in clinical studies. From rigorous adverse event monitoring to robust safety reporting, our scrutiny leaves no room for compromise. Rest assured, patient safety is our top priority.
Respecting and safeguarding the rights of patients is fundamental to ethical clinical research. Our audits thoroughly examine protocols to ensure that informed consent processes are robust and that patients‘ rights are upheld with unwavering diligence. We emphasize transparency, privacy, and compliance with applicable laws and regulations to protect and honor these rights.
Ensuring the integrity of your data is paramount. We’ll shine a light on data collection, management, and reporting, making sure your results are rock-solid.
We don’t just check boxes; we assess risks. Our audits are grounded in a risk-based approach to prioritize critical areas and resources.
People matter, too! We’ll evaluate your team’s training and development, helping you build a competent and compliant workforce.
Keeping the paper trail in order is no small feat. We’ll dive deep into your documentation to ensure it’s comprehensive and in line with regulations.
Smooth communication between departments is key. We’ll assess how different teams collaborate to ensure a harmonious compliance ecosystem.
We’re not just auditors; we’re knowledge sharers. We’ll provide insights and resources for your team’s ongoing learning and growth.
Our commitment doesn’t end with the audit report. We’ll work hand in hand with you to ensure corrective and preventive actions are taken promptly. We’re with you for the long haul!
In a nutshell, we’re your partners in compliance. With our expertise in ICH GCP E6(R2) and ISO 14155:2020, we make audits feel like a breeze, not a storm.
Ready to embark on this audit journey? Don’t hesitate to reach out to us. Your compliance adventure begins with a single click or call. Let’s make those audits an absolute success!
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