Ensuring Quality in Clinical Investigations

Strategic and Customized

With Biotex CRO+, you can expect a transparent and constructive audit process that identifies strengths and offers strategic recommendations for improvement.

Our specialized auditing services are tailored to instill confidence by providing thorough assessments, guaranteeing adherence to the highest standards, and establishing a collaborative partnership to enhance the efficiency and quality of your clinical investigations.

At Biotex CRO+, our commitment extends beyond the audit, as we actively collaborate with you to implement best practices and drive continuous improvement. We also understand the critical role that a reliable QMS, a trustworthy team, and efficient clinical investigation sites play in the success of your projects.

Choosing Biotex CRO+ as your auditing partner is a strategic investment in the success of your clinical endeavors. By partnering with us, you gain an auditing service and a dedicated ally in advancing clinical research, ensuring compliance, and achieving unparalleled excellence in your operations.

Compliant with Standards and Ethical Practices

Biotex CRO+ is a valuable partner in providing external audit services for a Sponsor/CRO or investigation site, ensuring a robust evaluation process. We align our practices with the ISO 14155 standard for Clinical Investigation of Medical Devices in Human Subjects, adhering to Good Clinical Practice (GCP).

Our audit process categorizes findings into Minor Nonconformity, Major Nonconformity, or Observations, providing a detailed understanding of the audit outcomes. You’ll also benefit from our collaborative efforts to ensure adherence to our defined procedure as various stakeholders, including auditors, audit team leaders, and regulatory personnel, work together to maintain the integrity of the audit process.

WHY INTERNAL AUDITS ARE ESSENTIAL TO YOUR STUDY

At Biotex CRO+, our commitment to providing unparalleled auditing services is underpinned by the exceptional qualifications and rigorous training of our auditors. We ensure our audit team surpasses the minimum requirements outlined in ISO 14155, encompassing education, experience, and specialized training.

We commit to engaging in a collaborative process with you as our auditors meticulously review the Audit Plan to align with specific objectives and expectations and ensure a tailored approach that addresses the unique nuances of your clinical operations. We also recognize the importance of transparency and communication throughout the auditing process, fostering a partnership beyond the examination.

During internal audits, our thoroughness is reflected in our detailed Audit Reports, providing you with a comprehensive overview of the audit, including Sponsor/CRO/site details, audit dates, staff present, identified findings, and an overall assessment. This meticulous documentation provides transparency and is a valuable resource to help you understand the nuances of the audit so you can make informed decisions for continuous improvement.