Clinical Trial Design Services

StatisticaMedica offers innovative and effective approaches to clinical trial
design, providing clear, measurable answers to design and strategy questions

Focussing on clinical trial design to enhance trial success

The design of a clinical trial is crucial to the progress and success of a clinical research programme. A well-designed trial will enable clients and clinicians to investigate important clinical research questions efficiently and accurately, with key design features formed to ensure the trial has a clearly defined primary clinical research question and is fit-for-purpose.  

StatisticaMedica collaborates closely with clients to optimise clinical trial design, thereby enhancing trial success and driving clinical research programmes towards a successful regulatory submission. Our expert biostatisticians approach clinical trial design with the aims and objectives of the trial and the biostatistical requirements of the regulatory authorities at the forefront.

Consultative Approach

StatisticaMedica’s consultative approach includes activities such as ensuring that the clinical trial hypothesis is translated into a statistically logical and valid set of trial-specific statistical tests and analyses that meet the criteria for acceptance by the FDA/relevant regulatory authority. Our team will also ensure that the clinical trial provides answers to your valid research questions with adequate statistical power to enable conclusions to be drawn. 

Proactive Engagement

Early biostatistical input in clinical trial design will increase trial quality, ensure regulatory compliance and maximise the usefulness of data, thereby potentially saving time and costs in the long-term. Our expert biostatistics team will address and fulfil the biostatistics requirements of your clinical trial from its initiation, providing a full range of efficient and effective design and set-up activities. 

We form an integral part of the trial team, offering flexibility and adaptability in our approach, whether as the sole provider of the biostatistics function or supporting and enhancing the biostatistics capacity within your project team.

There are many aspects and issues to consider when designing a clinical trial. Our expert biostatisticians will work closely with you to design a clinical trial that provides answers to your research questions with high confidence. 

Understanding the mindset of the regulatory statisticians

StatisticaMedica interacts directly with the FDA for regulatory submissions on our client’s behalf. Our insight into the regulatory biostatisticians’ requirements results in significantly reduced review times and minimises any FDA/other regulatory body questions on the clinical trial design and the data. 

Our Clinical Trial Design Services include:

  • Identifying optimal primary and secondary endpoints
  • Applying strategies for multiple and composite endpoints
  • Calculating the statistical power of the trial
  • Validating the rationale for sample size and sampling strategies
  • Developing randomisation schedules
  • Interim analysis planning
  • Reviewing trial measurements, assessment schedules and logistics to enable the generation of high quality, statistically valid data
  • Identifying robust and powerful statistical methods that are pertinent to the clinical trial and satisfy the highest regulatory standard
  • Designing and writing the statistical section of the protocol for efficient and reliable endpoints and statistical analyses that meet regulatory requirements 
  • Regulatory biostatistical consulting
  • Preparing for and attending scientific advice meetings with Notified Bodies to obtain approval for the initiation of the study
  • Other strategies, including trial simulation and adaptive study design

For further details on our Biostatistics Advisory & Consulting, click here.