Trusted support to meet the daily demands of transparency requirements
Let our experts become a seamless extension of your team.
MMS provides end-to-end Transparency services supported by our experts with deep experience in transparency laws, regulations, and industry requirements. You can trust MMS to tirelessly to relieve the day-to-day transparency activity burden by facilitating cross functional engagement, ensuring legal and regulatory compliance, and enabling responsible data sharing while maintaining patient privacy and the protection of company proprietary information.
Our global footprint enables quick mobilization, 24/7 support and the ability to scale to meet your needs.
We offer and use our award winning TrialAssure® suite of transparency applications to comprehensively support transparency activities.
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 PRCI, 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
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.
& Medical Writing
Quality & Compliance
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