Biostatistics

Biostatistics

Biostatistics: 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 biostatistics 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 clinical trial 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 biostatistical 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.

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.

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