MERIT CRO’s deep knowledge of the regulatory requirements for our specialized therapeutic areas forms the cornerstone for our successful management of clinical trial data.
Quality Assurance
Highlights:
- MERIT’s Quality Management System (QMS) is ISO 13485 certified
- We prioritize data privacy; MERIT is GDPR compliant in both our processes and with our proprietary EXCELSIORTM software
- EXCELSIOR is a 510(k) cleared medical device for ophthalmic and radiological indications that is HIPAA compliant and meets all 21 CFR Part 11 requirements for electronic records and signatures
- MERIT’s Information Security Management System (ISMS) is ISO 27001 certified
Our Quality Assurance team has extensive experience with GxP, ISO, ICH, software validation, auditing, medical devices, pharmaceuticals, quality management systems, process improvement, risk assessment, and CAPA.
QUALITY POLICY
MERIT strives to provide safe, reliable, efficient, high quality data analysis and management for clinical trials to the pharmaceutical and biotech industries. We are committed to consistently meeting all applicable regulatory requirements through maintaining and improving an effective and efficient quality management system and associated quality objectives.
EXCELSIOR IS A 510(k) CLEARED MEDICAL DEVICE
EXCELSIOR is a cloud-based software platform cleared with the FDA as a Class II medical device (K#220929), with specific indication for managing ophthalmic and radiological clinical trial data. Consequently, MERIT is organized as a medical device manufacturer, following cGMP.
21 CFR PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
MERIT’s flagship software, EXCELSIOR™, is a fully integrated platform that meets all regulatory requirements for 21 CFR Part 11 Electronic Records. There is a full audit trail that is provided in a human readable format to track each action taken in the data management process, including user access, upload of images, review of images in the quality control step, and each grading step. EXCELSIOR™ users are required to sign off on each step in the workflow for a two-point authentication per the regulatory requirements defined in 21 CFR Part 11.
GDPR
MERIT has taken the appropriate steps to become a GDPR compliant organization. The use of EXCELSIOR™ ensures that the data hosting and analysis at a reading center remains GDPR compliant. This means that MERIT verifies that the EXCELSIOR™ platform and MERIT internal framework ensures EU individual rights. Additionally, MERIT has the organizational measures in place to maintain GDPR compliance.
Individual Consent and Rights
- Stricter conditions for consent
- Right to rectification
- Right to erasure, right to be forgotten
- Right to data portability
- Right to object and automated individual decision making
Organizational Measures
- Data Protection Impact Assessment (DPIA)
- Inventory of all personal data
- Data protection by design and default
- Framework for GDPR Compliance
REGULATORY COMPLIANCE
MERIT meets the regulatory requirements of a medical device company. In addition, the Quality Management System is structured to support ongoing clinical and preclinical study activities, including:
- Electronic records
- Internal audits
- Archival of data
- Validation of computerized systems
- Software development life cycle procedures
- Business continuity and disaster recovery
- Vendor and contractor assessments and qualifications
To ensure ongoing regulatory compliance, MERIT supports a full suite of Standard Operating Procedures, Standard Evaluation Procedures, and Policies.
QUALITY MANAGEMENT SYSTEM
MERIT’s Quality Management System (QMS) has been designed to provide the structure and controls required for EXCELSIOR™ as a medical device, and to support clinical study execution and ensure that our processes meet industry standards. Our QMS is ISO 13485 certified and includes technical and procedural controls that reflect 21 CFR Part 820 Quality System Regulation, ICH E6 (R2), and GxP industry standards.
INTERNAL AND SPONSOR AUDITS
We regularly perform internal audits to ensure study data quality and compliance to MERIT’s Quality Systems requirements and industry regulations. In addition, MERIT routinely hosts sponsor audit activities and supports inspections conducted by regulatory agencies. Our Quality Assurance and Regulatory Affairs (QA/RA) team works with clients and partners to support meeting regulatory requests and/or on-site inspection requirements, including sponsor-run mock inspections.