Full Service Biometric Solutions

Given our data-focused expertise, MMS removes the frustration that can arise from managing multiple vendors. By handling this process for you, MMS will receive the data from multiple sources and ensure it is quality checked and consolidated into industry standard formats such as STDM and ADAM for analysis and submission requirements.

MMS can provide you with earlier insights into your data. Since we are intimately familiar with all major EDC systems, including Zelta and Rave, MMS data scientists can capture study information as soon as it is collected to present your data management queries and clinical data sooner.

MMS works as a team to ensure that your data receives consistent treatment throughout the drug development process. Data Science works closely with Biostatistics and Programming to ensure that our statistics presented are consistent and honor the statistical analysis plan (SAP).

The “One MMS” motto comes into full effect as we manage all the data hand-off from one specialty area to another. In fact, we put in place some of our own tools, such as Datacise® Workbench and Explore, as well as an automated process for creating immutable tables (in-text tables) for direct importing into your CSR to expedite this process.

At MMS, you can expect world-class tools and technologies to ensure your project’s success, including:

• Electronic Data Capture using Zelta, Rave, and others
• Datacise® Workbench to automate SDTM (Study Data Tabulation Model) creation
• PVantage™ to assist with medical review
• SAS and R to create consistent and accurate statistics
• Datacise® to help you quickly gain insights into your study’s data
• Statsols Nquery for sample size estimations and power calculations

Given the experience and familiarity with these tools, MMS delvers results to you in a more efficient and timely manner. Automation is integrated into MMS processes where it makes sense, and we incorporate data checks at key points in the data chain to ensure the utmost quality.

Specifically, MMS does this by:

• Accelerating your study’s implementation by leveraging pre-built macros and forms to accelerate SAS programming and EDC builds
• Quickly revealing data quality issues by incorporating real-time edit checks
• Implementing holistic data checks to identify potential issues across the study data, such as missed visits
• Focused reviews of data anomalies impacting the estimands of your study
• Delivering validated dashboards using automated rival programming techniques

As one study follows another, MMS can help you answer some big questions: Is this study comparable to previous studies? Do the trial assumptions hold, based on the data (e.g., comparing event frequency)?

MMS is different than other biometrics CRO vendors, as we bring a long-term vision and work together with you from the start to get your data organized and ensure that these types of questions are easily answered as they arise.

Whether MMS starts with you from the first study or we join later in the product development journey, you do not have to worry about gathering and reporting across studies. MMS routinely incorporates historical data from multiple sources and formats to deliver a common set of cross-study data to analyze via Datacise® Explore. Similarly, for NDA submissions, we can handle your Integrated Submission for Safety (ISS) and/or Integrated submission for Efficacy (ISE) pooling, analyses, and packaging towards that goal.

One challenge that small to mid-sized companies quickly face is how to scale up. In the beginning, it is easy to manage data with Excel, but as studies grow or the need to incorporate RWD into a project arises, it’s easy for many to outgrow their own capacity.
At MMS, advanced data engineering tools and processes ensure that data can be properly ingested from multiple providers and be combined to provide meaningful information.

We are just as comfortable handling complex data requirements for a rare disease study as we are handling data requirements for a small, simpler study. Given our experience with working with Environmental, Health, and Safety (EHS) and insurance claims data, MMS will evolve your RWD into the RWE (Real World Evidence) that can be used in submissions to to global regulatory bodies.

Additionally, for any type of study or program of studies, MMS can:

• Augmenting your program with real world and safety data
• Providing historical control data for your study
• Assisting in planning your studies based on RWD and simulations

Driven by quality, our global experts at MMS approach every Biometrics and Data Science deliverable as a top priority, no matter how big or small the project may be. You can expect in-depth, thoughtful conversations with team members, knowing that they are thought leaders, invited speakers, and change makers in industry groups across the globe.