Data Management

Overview

Data. What’s not to love?

At Cmed, we love data. Because without data, there is no product – it’s just that simple. Cmed Data and Analytics services help you make sure you have the right data at the right time, managed with the appropriate controls in place. Let us help you combine, centralize and distribute clinical trial data in an accurate, quick and clever way.

Data is what we do

Managing and analyzing data is about more than checking the boxes. And it takes more than having good systems, processes and integrations in place. It’s about having people with a deep understanding the data – and how to get it to you most effectively to drive critical product decisions.

Trusted experience

Data and Analytics are part of Cmed’s DNA. For the past 16 years, across more than 500 projects, we have capitalized on all our experience to evolve and combine data skill sets and technologies, giving you the tools you need to access, understand and analyze your data. Our experts come from pharma and CRO backgrounds – so we understand how to get you there.

Serious data skills

Our Lead Data Managers, Statisticians and Analysts have more than 16 years’ experience across a number of key skills including Data Management, Biostatistics, Medical Writing, Pharmacovigilance and Project Management. We recognize and act upon challenging situations before they become an issue, and work hand in hand with you to deliver your study. Because the landscape keeps changing, we keep upgrading our skills. We don’t just deliver – we put you at the center of what we do.

By the numbers

  • 500+ studies across multiple therapeutic areas with key experience in oncology and rare diseases.
  • 6-8 weeks to build databases for you. Sometimes faster!
  • Statistical results can be obtained within 5 days of database lock.
  • We have worked globally with 5 of the top 10 Pharma companies.
  • Preferred provider in translational medicine, adaptive oncology design and for several mid-Pharma and biotech companies.
  • Customer relationships that have lasted more than a decade.
  • Expertise across multiple systems (in-house EDC, RAVE®, SAS, R, Cognos®, etc.)
  • Have delivered eSource studies across different systems.
  • Significant experience in rescue studies.
  • Our management team has an average 22 years’ experience.

Superior delivery

We put ourselves in your shoes to help you on every step of the journey. The Cmed team engages before study start-up and gives our all to help you deliver successfully.

Data Management

We thrive on the challenge of complex trials. Since 2000, Cmed’s expert data management team has provided a full range of cost-effective services and solutions. Our team’s capabilities rival those of a larger CRO, with the added benefit of highly personal customer service. With experience across all phases and most indications, we deliver consistently.

Our Lead Data Managers undergo a strict training program – not only on technical details but also on project fundamentals. So you’ll be in good hands.

Key services

  • Database design and setup to give you a reliable system within 6-8 weeks of start-up.
  • Integrated tools for automatic generation of documentation, reducing compliance risks and providing better alignment across functions – have everyone sing from the same sheet of music.
  • Experience with Cmed’s new generation Clinical Data Suite encapsia® and other systems such as RAVE® and INFORM®.
  • Extensive computerized system validation experience. All systems are 21CRFPart 11 compliant.
  • Complex designs are routine for Cmed. We can easily program adaptive designs with no system shutdown for protocol amendments using Timaeus® system.
  • Understanding of the up- and down-stream effects of data changes. We work very closely across all data and medical functions to ensure overall better quality data.
  • A suite of reporting tools and dashboards for ongoing access to your data. View or query at any given point in time, whenever you need.
  • Holistic review of the data with the use of analytics and central data monitoring tools. We are all looking at the same data and for better management of that data (for example better identification of unplanned data challenges).
  • Cost-effective solutions supported with the ability to review data remotely.
  • Significant experience in rescue studies. Contact us for our case studies.
  • Design and management of eSource studies using Cmed’s new generation encapsia® Clinical Data Suite.
  • Long-standing relationships.

Praise from our customers

We have a very efficient collaboration because you know and understand the study very well and can translate our needs into data.

Biostatistics

Statistics: often misunderstood, always underappreciated. But not at Cmed! From early planning to data interpretation, statistics support is the lynch pin to your product’s approval. Cmed provides complete statistical services – from study design consulting to full service clinical trial support of Phase I to Phase IV clinical trials – across a comprehensive portfolio of therapeutic areas.

Make the data sing

Interpretation is why we gather data to begin with. Data itself is worthless without the right statistical expertise to guide you. We’ll make the most of your data, from the smallest POC study to the biggest Phase III Oncology study and beyond. When it comes to data, Cmed delivers.

How we deliver

  • Statistical expertise as our standard.
  • Careful and frequent project and resource planning for your projects to ensure statistical coverage.
  • Operating to specifically defined standards, covering the entire process.
  • Assessment and understanding of the study design.
  • Clear analysis plans, analysis dataset specifications and full table, listing and figure shells.

Expert consultancy

Cmed offers statistical consultancy services for product development, providing timely and efficient statistical input through all stages of the clinical trial process:

  • Effective Trial Design and expert input into protocols so proposed analyses have a good chance of reaching a useful conclusion (in a world of variation) and help ensure there is a reliable basis for evaluating the safety and efficacy of treatments.
  • Utilization of varied and complex statistical techniques to support any trial, in any phase, any indication, any complexity.
  • Subject Matter Experts in place to support DSMB and Regulatory Submission meetings.
  • CDISC expertise (full CDISC programming and cost effective legacy conversion).
  • Integrated summaries for safety and efficacy.
  • Key statistical input to ensure the analyses and results of trials are correctly interpreted and communicated.
  • Design of individual studies and programs include endpoint selection; randomization strategy; statistical methodology; sample sizing/alpha spending/interim analyses strategies; DSMB advice and support; data collection and monitoring; statistical review; and critique of existing data packages/studies.

Working with you – not just for you

When it comes to clinical trials, we want the results now (or even sooner!). With increasing diversity and volumes of data to be analyzed, your statistician does more than just run tests and algorithms. They provide you with insights and expertise to help you make the best decisions as quickly as possible. Our experts have an eye for understanding clinical data but also a holistic view across multiple functions.

Praise from our customers

Finding a specialized service provider who is reliable has always been a challenge for us but working with your team has really made us rethink how we can run our trials more effectively in the future.

Project Management

Project management brings it all together. Over the years, Cmed has developed a robust project management model in Data and Analytics, ensuring we help you keep your projects on track from start to finish.

Our experience

We have delivered more than 500 studies in 16 years – so we have a deep understanding of your resources, needs and expectations for reduced timelines and efficient processes. Our approach delivers:

  • Project management for projects where Data Management, Biostatistics, Pharmacovigilance and Medical Writing services are required in combination.
  • Program management for Functional Services managing a portfolio of 80 ongoing studies/year.
  • Continually improving our processes to meet customer needs – for example, reduction of setup times by 20% and the implementation of complete CDISC libraries in less than 12 months.
  • Support for companies with no data and analytics experience – our experienced leads work directly with the client’s clinical team.
  • Management of rescue studies.

Smart methodology

Our Data and Analytics Project Managers are all trained professionals with more than 16 years’ experience. They work hand-in-hand with your team to review all key documentation to prepare an effective strategy – taking you from kickoff to final deliverables.

Praise from our customers

My project was always in a safe pair of hands with you – thank you!

Want to learn more?

Please feel free to contact us if you would like to learn more about our skills and experience. We are friendly, open and here to help.

Contact us