CLINICAL TRIAL TRANSPARENCY AND DISCLOSURE SERVICES

Trusted support to meet the daily demands of transparency requirements.

Let our experts become a seamless extension of your team.

Clinical Trial Transparency and Clinical Trial Disclosure Services

MMS provides end-to-end transparency services supported by our experts with experience in transparency laws, regulations, and industry requirements. Trust MMS to alleviate the day-to-day activity burden of transparency 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 team enables quick mobilization, 24/7 support, and the ability to scale our services to meet your needs.

 

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), EU Clinical Trial Information System (EU-CTIS), and other international registries. Our robust services, processes, and tools allow MMS to be your centralized transparency department with the ability to manage all workflow and clinical data reporting obligations for an entire pipeline.

As disclosure legislation has evolved multi-fold across the world over the past two decades, MMS Clinical Trial Disclosure experts are here to advise, prepare, automate, and manage compliance with Sponsors’ disclosure obligations through a preferred partnership with TrialAssure.

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 data set
  • Automated calculation 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’s SOPs and organizational structure

MMS has a comprehensive suite of services for disclosing your clinical trials on various international registries, including:

  • Protocol registration to clinicaltrials.gov, EudraCT, EU-CTIS, and more
  • Post release site and status updates, protocol amendment updates in accordance with the registry and regulatory requirements
  • Results posting to clinicaltrials.gov, EudraCT, EU-CTR, and several local registries
  • International registries support
  • Redaction of protocol, statistical analysis plan, and synopsis for clinicaltrials.gov and company websites
  • Compliance monitoring
  • Consulting support through training and workshops

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Clinical Trial Transparency and Clinical Trial Disclosure Services

Key Differentiators for the MMS Clinical Trial Disclosures team:

  • Industry experts with combined experience of over 55+ years in the clinical trial disclosure space
  • Quality-focused services: 98% of registration accepted by the National Institute of Health (NIH) in first release of 2022)
  • Seamless integration with client teams for workflow management of disclosure deliverables
  • Excellent domain knowledge, including registry databases, therapeutic areas, review criteria of regulatory agencies, and more.
  • Hands-on experience of working with regulatory agencies like the US-NIH and the EMA
Clinical Trial Disclosures Team’s Mission Statement

The clinical trial disclosure services within our transparency organization is dedicated to delivering high-quality, timely, and compliant clinical trial information and data for patients, researchers, and the general public. This is accomplished through the tireless efforts of our subject matter experts and industry-leading technologies.

Clinical Trial Disclosures Team’s Vision

The clinical trial disclosure team aspires to add value to our Sponsors, trial participants, and the general public through responsible sharing of clinical trial information and data. We work tirelessly to mitigate risk to our Sponsors and ensure the privacy of patients. We strive to be the partner of choice for Sponsors and be recognized as an industry leader in the clinical trial disclosure domain.

ANONYMIZATION OF DOCUMENTS

MMS is an innovator of risk-based clinical trial document 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. We offer:

  • Document anonymization and/or redaction
  • Assessment of confidential proprietary information
  • Streamlined process for meeting regulatory requirements
  • Quantitative risk assessment for anonymized documents
  • Anonymization reports

The flexibility of our teams is key in preparing large projects, compliance to EMA Policy 0700, HC PRCI, or EU CTR Regulations, data sharing and collaboration with researchers, and other transparency initiatives.

To ensure the highest level of data utility, all document anonymization work is performed by a cross-functional team, including clinical trial data analysts, biostatisticians, and medical writers, with the ability to anonymize studies in batches.

ANONYMIZATION OF DATA SETS

MMS’ risk-based dataset anonymization approach protects patient privacy and maximizes the data utility by keeping the risk below our predetermined threshold. Our process is proven to produce high-quality anonymized datasets with less manual effort. The anonymization of each variable is driven by a standard rule set that can be reused across multiple studies. Our rule-building technology allows us to switch rules based on the personal information in each variable. Our tool can anonymize individual patient level data in different data sources, including SAS transport files, SAS7BDAT, Excel, and CSV.

Key highlights to our process:

  • Designed based on EMA Policy 0700, Health Canada, FDA, Transcelerate, and PhUSE guidelines
  • Integrated risk-based data anonymization
  • Rule-building technology
  • Balanced privacy and data utility
  • Secure cloud-based SaaS
  • Available integration with data-sharing platforms
  • Comprehensive report and audit trail

Anonymization deliverables include:

  • Anonymized datasets
  • Anonymization and risk assessment report
  • Rules sheet
  • Anonymization keys
Anonymization Team Mission Statement

The clinical trial transparency team is dedicated to delivering high-quality documents and data, ensuring the protection of personal and confidential information, while balancing data utility. This is accomplished through the efforts of our global team members, subject matter experts, and preferred partnership with industry-leading technologies.

Anonymization Team Vision

The clinical trial transparency team aspires to exceed our Sponsors’ expectations using risk-based assessment and transformation of data in their clinical study documents. With our proven processes and preferred partnerships with industry-leading technology, we strive to provide anonymized documents with maximum data utility in alignment with global regulatory agency expectations and guidelines. Our goal is to maintain a customer focus throughout the product lifecycle, ensuring the customer experience is positive, trust is built, and we create long-term relationships.

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 aligned 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 (ICFs)

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