WCG Certifications & Accreditations
A trusted technology partner for clinical trial sponsors, CROs, and sites
We recognize the significance of the trust our clients and partners place in WCG. Upholding this trust, WCG commits to standards of security and service excellence, as validated by our industry-recognized certifications. Explore more about our dedication below.
ISO 27001:2022
The certification applies to WCG products and businesses supported by WCG’s Technology Solutions shared services.
This certification encompasses WCG’s Technology Solutions shared services, which bolster WCG clinical services. WCG is committed to information security and data protection, consistently adhering to the stringent ISO 27001:2022 standard. This globally recognized standard fosters information security best practices and affirms WCG’s dedication to a comprehensive and effective Information Security Management System (ISMS). Our ISMS ensures the safeguarding of confidentiality, integrity, and availability for all our information assets, as well as those of our clients, partners, and stakeholders.
ISO 9001
The certification applies to WCG’s IRB and IBC services.
WCG’s ISO 9001 certification recognizes our dedication to quality service, ensuring our clients benefit from the highest standards of quality management. This certification signifies our adherence to a robust quality management system, focusing on strong customer experiences and continual process improvement. It demonstrates our commitment to not just meet, but exceed client expectations, providing partners with top service and maintaining the highest standards.
AAHRPP Accreditation
The certification applies to WCG’s IRB services.
In 2003, our flagship IRB was the first central IRB to receive accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP®), an organization that endeavors to improve safeguards for clinical research participants. As per AAHRPP requirements, WCG IRB undergoes the organization’s rigorous reaccreditation process every five years. Most recently, we were awarded reaccreditation status by AAHRPP in September 2019.
HIPAA
The certification applies to WCG MyPatient & iConnect supporting WCG Site Augmentation Solutions.
WCG’s HIPAA certification ensures that clinical trial participants protected health information (PHI) is handled with the highest level of confidentiality and security. As a HIPAA-certified entity, we adhere to stringent standards to safeguard sensitive data and protect against unauthorized access and breaches. This certification reflects our commitment to maintaining trust and integrity in all our client interactions, offering peace of mind that PHI is managed responsibly and in compliance with regulatory requirements. Our dedication to upholding these standards is a cornerstone of our service, reinforcing our role as a reliable and ethical partner in the healthcare industry.
FDA Compliance
Our organization is routinely inspected by the Food and Drug Administration (FDA) – and found to be in good standing and compliant with federal regulations. This underscores WCG IRB’s commitment to championing scientifically and ethically sound research, safeguarding clinical trial participants, and demonstrating continuous improvement.
Debarment Certification
WCG verifies the debarment status of its employees to help maintain compliance with FDA regulations, which are crucial to the success of clinical trials. Our due diligence fosters a trusting relationship with clinical research sponsors and CROs, which is essential for collaboration in regulatory environments.