Quality and Compliance services
Experts support to meet the demands of the ever-shifting global regulatory environment.
Our proven expertise, knowledge, and processes give sponsors flexible solutions with rigid compliance.
GxP Audit Services
Restrictions on travel and lack of access to clinical sites has forced delays for many pharmaceutical Industry audits and shifted others to remote-only. As organizations return to full operations, some GxP audits are likely to remain remote to reduce costs, while others require an experienced auditor to be on-site.
Why MMS for Auditing?
When you choose MMS for your GxP and compliance auditing services, you’ll work with experienced auditors backed by strong processes.
- We assign each sponsor a dedicated point of contact with at least 10 years’ experience as a GxP auditor working within research.
- Your point of contact manages the delivery of audit work to hit timelines, ensuring consistently high quality of deliverables and transparency of KPI reporting.
- The MMS team is known for our well-defined processes with robust internal systems support and our relentless commitment to consistently deliver the highest quality results on time.
- Our auditors have access to in-house IT support to assist with Sponsor technology systems as needed.
We have GxP audit compliance services consultants located in Europe and US available now for global assignments.
Types of Clinical Audits
- Investigator Site Audits
- Routine, Targeted and For Cause
- Inspection Preparation/training
- Phases I-IV
- Mock Inspections
- Vendor Audits
- Project Management
- Data Management, Biostatistics and Medical Writing
- Clinical Trial Supply
- Interactive Response Technology
- Translation Services
- Archive Facilities
- Centralized ECG/Imaging
- Central labs, BioA labs and Specialty labs
- Audits of Sponsors/CRO/ Phase 1/BA Laboratories
- Document Audits
- Case Report Forms
- Informed Consent
- Investigator Brochures
- Clinical Study Reports
- Development Safety Update Reports
- Protocol Audits (all Phases)
- Trial Master File Audits (paper/electronic)
- System Audits
- Bespoke audits
- Sponsor System/process audits
- Clinical Database audits
- Pharmacovigilance systems
Vendor Management as a Service
CRO and CMO partnerships are very important throughout the drug development lifecycle, but the responsibility doesn’t end with creating and fulfilling the contract alone. Sponsors are required to qualify, evaluate, and assess their vendor partners on an ongoing basis and maintain adequate records to prove these activities were completed. Compliance with E6 R2 stresses a heavier focus on risk-based monitoring and implementation of quality agreements and associated quality indicators as well.
MMS offers a full suite of vendor management services as well as ad hoc vendor management support to support complying with regulatory requirements for vendor oversight.
Our vendor management services include:
- Gap assessment of a current vendor management program to determine the level of compliance
- Vendor qualification or requalification
- Routine and for-cause audits
- Development of vendor management program, KPIs and KQIs
- Quality agreements and service level agreements
MMS has the proven expertise, knowledge, processes, and documentation library to provide organizations with regulatory-compliant Vendor Management Services or create a complete custom program.
Inspection Readiness and Preparations
Give your organization the ability to respond confidently to a regulatory authority inspection or investigation requests with inspection readiness and preparations by MMS. Led by former health authority personnel, MMS experts provide comprehensive pre-inspection reviews of facilities, processes, documents, and staff member preparedness.
MMS conducts mock regulatory authority inspection audits to ensure that all sponsor staff is prepared for the variety and volume of requests that accompany any regulatory inspection at the plant or facility, third-party vendors, suppliers, laboratories, clinical sites, and/or contract manufacturers. Additionally, process, document and facility audits are conducted in conjunction, providing the added benefit of uncovering potential observations and allowing for resolution or mitigation before the actual regulatory authority inspection.
Uncovering and addressing findings at this primary juncture provides sponsors the added security of knowing that all inspection and compliance potential areas are under control.
Quality Management Systems
Uniquely focused on quality and compliance, MMS supports a wide range of sponsors in need of Quality Management Systems (QMS) development, including those completing large-scale mergers and acquisitions that may need to streamline and improve an existing QMS.
At MMS, there is no one size fits all approach to providing QMS services – as all organizations have inherent differences. This forward-thinking, risk-based approach ensures that sponsors gain efficiency and reduce the risk of non-compliance with customized programs for:
- QMS Evaluation and Gap Assessment, including specialized areas of IT or requirements surrounding GDPR
- Procedure Support, including a thorough evaluation and customized QMS project plan that ensures end-to-end compliance through policies, process maps, standard operating procedures (SOPs), work instructions, and associated forms and templates
- Organizational Structure Support, including implementing organizational charts, position descriptions, development of strategic business planning framework, and key performance indicators
- Quality & Compliance Support, including quality and compliance support to help sponsors meet various regulatory, ISO, and Data Privacy requirements and standards
- Training Support, including determining requirements, supporting the implementation of tools and systems, and serving as a training partner through creating and delivering training modules, hosting a Learning Management System (LMS), and management of training records
Over the past year, many professionals in clinical research have had to navigate through uncharted waters and adapt to remote auditing due to the COVID-19 pandemic. While the landscape of auditing has changed, the basics of confirming compliance remains the same.
& Medical Writing
CONNECT WITH US