As a Contract Research Organization, OrciTrials is dedicated to advancing medical research and improving healthcare outcomes through Pre-Clinical and Clinical Trials. In addition to our core services, we also offer Quality Assurance and External Audit services to ensure that our clients’ trials are conducted in compliance with global regulations and best practices.
OrciTrials’ Commitment to Advancing Medical Research and Improving Healthcare Outcomes
Our team of experienced auditors and quality assurance professionals provide comprehensive support to clients in all stages of their clinical trials, from protocol development to final reporting. We have extensive knowledge and experience in global and local regulations, guidelines, and our audits are tailored to meet the specific needs of each client.
Regulatory compliance
We ensure that all aspects of the trial, from informed consent to report writing and publication, are conducted in compliance with global regulations.
Good Clinical Practice (GCP) compliance
We assess whether the trial adheres to GCP guidelines, ensuring the integrity of the data and the safety of trial participants.
Clinical Quality Control Services
OrciTrials also provides Clinical Quality Control (QC) services to ensure that clinical trials are conducted to the highest standards of quality. Our experienced team of professionals provides ongoing monitoring of the trial to identify and resolve issues that may impact the accuracy and reliability of the trial results.
Ongoing Monitoring to Regulatory Compliance
Our Clinical Quality Control services include regular site visits, source data verification, and ongoing review of clinical data to ensure that the trial is progressing according to the protocol and meeting all regulatory requirements. Our goal is to help our clients achieve their trial objectives by ensuring that their study is conducted to the highest standards of quality and compliance.
Process of External Audits
Our external audit process is designed to provide a comprehensive review of the clinical trials, covering all critical aspects of the clinical study. Our team of auditors follows a rigorous process that includes a detailed review of the trial documents, on-site visits, and interviews with study personnel to ensure that all processes are compliant with global regulations and best practices.
List of documents typically audited during a clinical trial. This list includes:
- Trial Master File (TMF) – a collection of essential documents related to the clinical trial.
- Informed Consent Form (ICF) – a document that outlines the purpose, risks, and benefits of participating in a clinical trial.
- Case Report Form (CRF) – a document used to collect data from each participant in the study.
- Investigator Brochure (IB) – a document that provides essential information about the drug or device being studied.
- Protocol – a document that outlines the objectives, design, methodology, statistical considerations, and organization of a clinical trial.
- Statistical Analysis Plan (SAP) – a document that outlines the statistical methods to be used in analyzing the data collected during the trial.
- Clinical Study Report (CSR) – a document that summarizes the results and conclusions of the trial.
- Data Management Plan (DMP) – a document that outlines the procedures for collecting, managing, and analyzing data during the trial.
- Adverse Event (AE) and Serious Adverse Event (SAE) reports – documents that report any adverse events or serious adverse events experienced by participants during the trial.
- Investigator Brochure – a document that outlines the procedures for handling and dispensing the investigational drug or device.
- Monitoring Plan – a document that outlines the procedures for monitoring the conduct of the trial.
- Quality Management Plan (QMP) – a document that outlines the procedures for ensuring the quality of the trial conduct and the data.
Note that this is not an exhaustive list, and the documents required for an audit may vary depending on the specific trial and regulatory requirements.
Benefits of External Audits
External audits provide several benefits for clients, including increased confidence in trial results, improved data quality, and reduced risk of non-compliance. Additionally, external audits can help identify potential issues early on in the trial, allowing for corrective action to be taken before the trial is completed.
Collaboration with Sponsors
We work closely with our clients and their sponsors throughout the external audit process, ensuring that all audit findings are communicated clearly and that corrective action plans are developed in collaboration with all parties. Our collaborative approach ensures that all stakeholders are aligned on the path forward and that the trial is conducted to the highest standards of quality and compliance.
GCP Auditing Experience
At OrciTrials, our team of auditors has extensive experience conducting external GCP audits of clinical trials. We have audited trials in a wide range of therapeutic areas, including oncology, cardiology, infectious diseases, and more. Our team has a deep understanding of global regulations and best practices, ensuring that our audits are comprehensive and rigorous.
Clinical Quality Assurance Reporting
At the end of each external audit, we provide our clients with a detailed report that includes all audit findings and recommendations for corrective action. Our reports are designed to be clear and easy to understand, providing clients with a comprehensive overview of the trial’s compliance status and areas for improvement.
The Importance of External Audits in Clinical Trials
External audits are a critical component of ensuring the quality and compliance of clinical trials. At OrciTrials, we are dedicated to providing our clients with the highest quality external audit services, leveraging our experience, expertise, and collaborative approach to ensure the success of each trial.
Partnering with OrciTrials for Quality Assurance and External Audit Services
At OrciTrials, we understand the importance of quality assurance and external audits in ensuring the success of clinical trials. By partnering with us for these services, our clients can rest assured that their study will be conducted to the highest standards of quality and compliance.
Tailored Services for Global Clinical Trials
Our Quality Assurance and External Audit services are available anywhere in the world where our clients’ clinical trials are running. Our team works closely with clients to tailor our services to their specific needs, ensuring that they receive the support and guidance they need to achieve their study objectives.
Committed to Delivering High-Quality Clinical Trials
OrciTrials is committed to delivering high-quality Pre-Clinical and Clinical Trials, and our Quality Assurance and External Audit services are an integral part of this commitment. We are dedicated to ensuring that our clients’ studies are conducted to the highest standards of quality and compliance, and we look forward to working with our clients to achieve their study objectives.
