Compliance and Transparency
Experts at the forefront of change to meet and exceed a shifting global regulatory environment.
Expertly-crafted solutions allow sponsors flexible implementation with rigid compliance.
Compliance and Transparency Services
With leaders positioned around the globe, MMS compliance and transparency teams are active contributors to industry standards and working groups, structuring compliance programs for sponsors of all sizes. Industry and global health authority experience combined with proven processes lend peace-of-mind to sponsors who need the most dependable, responsible, and driven professionals.
Anonymization of Datasets and Documents
MMS is a pioneer of risk-based clinical trial document and data anonymization, with industry thought leadership and the use of advanced tools to achieve both efficiency and quality in every deliverable. Internal anonymization processes and tools are designed to maximize data utility and protect patient privacy at the same time, while offering:
- Process development inclusive of ‘transparency ready’ templates
- Data anonymization (or de-identification),
- Document anonymization and/or redaction,
- Risk of re-identification assessment for anonymized data, and
- Risk of re-identification for anonymized or redacted documents.
This flexibility is key in preparing for big data projects, compliance to EMA Policy 0070 or HC PPCI, data sharing or collaboration with researchers, and other transparency initiatives. To ensure the highest level of utility, all data anonymization work is performed by a cross functional team, including clinical trial data analysts, biostatisticians, and medical writers, with the ability to anonymize, or de-identify, studies in batches.
Clinical Trial Registration and Results Disclosures
MMS helps sponsors achieve and surpass clinical trial disclosures reporting requirements for ClinicalTrials.gov, the European Union Clinical Trials Register (EU CTR), and other international registries. An integrated disclosure solution allows MMS to be your centralized transparency department and manage all workflow and data summarization obligations for an entire pipeline.
As legislation increases in complexity, MMS experts are here to automate and manage compliance through a preferred partnership with TrialAssure. Engaging MMS provides:
- Simple workflows to progress studies through the disclosure lifecycle
- Insights into transparency requirements for all global registries
- The ability to share data with multiple registries from a single dataset
- Automatic calculation for all disclosure due dates
- Customized reports to evaluate compliance risks and identify bottlenecks in operational processes
- MMS is fully equipped to recommend best practices based on our industry experiences and knowledge of
- Sponsor SOPs and organizational structure.
Lay Summaries of Clinical Trial Results for Laypersons (Lay Summaries)
As an industry leader in the creation of lay summaries, MMS develops programs for sponsors to meet and exceed future regulations. With a team of dedicated lay summary writers, graphic designers, lay reviewers, and project managers, the specialists at MMS are singularly focused on ensuring the success of every lay summary created.
Lay summaries increase public interest and trust in the clinical research process, but implementing a new deliverable, understanding industry best practices, and distributing these documents can be daunting without the right partner. MMS experts ensure that all lay summaries present accurate, non-promotional information that are meaningful and understandable to the average person.
Lay summary support includes:
- Writing plain language summaries
- Improving existing lay summaries
- Lay review (review and input by a panel without medical or scientific training)
- Template development and alignment with regulation-required elements
- SOP development and consulting
- Graphic design and layout
- Translation into local languages
- Distribution via patient communication portal
- Review of other patient-facing materials, including Informed Consent Forms
Domestic and International GxP Compliance and Auditing
The MMS auditing program was developed in-house by former regulatory authority investigation division staff to ensure that auditor training and audit conduct is modeled after internationally-recognized requirements in all GxP areas, including:
- Good Clinical Practices (GCP) Auditing
- Good Laboratory Practices (GLP) Auditing
- Good Clinical Laboratory Practices (GCLP) Auditing
- Good Manufacturing Practices (GMP) Auditing
- Software and System Validation and Life Cycle Auditing
This program provides sponsors with the identification of root causes of issues, as well as recommendations for remediation – ensuring that the sponsor and audited facility benefit from every audit performed. With auditors available globally, MMS auditors offer unique perspectives into how regulatory authorities view and act on deficiencies, risks associated with noncompliance at every level of pharmaceutical manufacturing and research, and development of actions to mitigate audit findings, including employee training, QMS processes and CAPA management, and vendor oversight.
Inspection Readiness and Preparations
Give your firm 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 are 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 Systems Design and Evaluation
Uniquely focused on quality and compliance, MMS supports a wide range of sponsors from smaller groups in need of Quality Management Systems (QMS) development to large global pharmaceutical companies, 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
Lay Summary Whitepaper
This whitepaper will explain the ins and outs of lay summary writing, the importance of starting a pilot program, a checklist for lay reviewers, and strategic advice for becoming more transparent.