Clinical Quality Assurance
Rely on our Clinical Quality Assurance expertise to fortify your organisation's credibility, seamlessly upholding patient safety and ethics.
Pathway to Quality Excellence Tailored Assurance for Biotech Clinical Trials.
We deliver our comprehensive Clinical Quality Assurance services through a collaborative partnership model, ensuring tailored solutions that align with your biotech objectives and standards.
QMS Development and Implementation
From documenting Standard Operating Procedures to managing Quality Control activities, we establish systems that enhance your clinical trial operations and ensure compliance and effectiveness.
Standard Operating Procedures (SOP) Writing
Our team assists in developing SOPs tailored to your operations, ensuring all procedures are standardized, repeatable, and aligned with regulatory requirements. An effective SOP equates to reduced errors, increased efficiency, and improved compliance in your clinical trials.
ISO 9001 Certification Preparation
Our team guides you through the necessary steps to achieve and maintain ISO 9001 certification, this globally recognised standard.
DMS / eDMS Compliance
As clinical trials advance, so does the need for efficient Document Management Systems (DMS) and electronic Document Management Systems (eDMS). Our team assists you in implementing and managing a quality DMS/eDMS, ensuring the integrity, security and accessibility of your documents, auditable at all times.
Training of Personnel
Our comprehensive training programs equip your team with the knowledge and skills required to uphold quality standards in your clinical trials. From understanding regulatory requirements to implementing Quality Control procedures, we empower your team to adopt a quality mindset.
Auditing Services
Our auditing services ensure the integrity and quality of your clinical trial processes. Whether you require an initial on-site audit, a routine audit, a for-cause audit, or a vendor audit, our experienced auditors can provide the in-depth assessment you need. Also, we specialize in GCP/GVP/GMP, project management and process audits to ensure every aspect of your trial meets the highest quality standards.
Mock Inspections and Audits
To prepare you for real-world regulatory inspections, we offer mock inspections and audits. These simulations are invaluable tools for identifying gaps, areas for improvement and implementing both, corrective and preventive actions, before an actual regulatory inspection occurs, thus enhancing your readiness and confidence.
Outsourcing of QA Department
We provide a complete outsourced QA department solution, enabling organisations to tap into our expertise, streamline their core activities, and uphold the highest standards of clinical trial compliance and quality
Global Coverage
Celero Executive team have experience in 80 trials across multiple clinical development phases (P1-P4) in more than 29 countries (US, EU, LATAM, APAC and Africa).
Introducing the Celero Way
A pathway to high-quality, cost-controlled, accelerated trials tailored to your needs.
Learn more about The Celero Way or speak to our Clinical Quality Assurance expert.
Speak to an Expert
Speak to an Expert
We are successfully ISO 9001 certified, which further underscores our commitment to meeting internationally recognized quality standards for quality, reliability, and excellence.