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Five statistical tips to consider when designing clinical trials!

Classic Solutions

Protocol Design – As an integral member of the clinical team, we aim to develop the protocol in close collaboration with your clinical leaders and scientists. We encourage meetings to be held in person, rather than relying on email. Let us come to you, so that we can provide expert biostatistical guidance.

Randomisation – Simple, block, or dynamic, correct randomisation is critical to the success of your trials. We will produce and validate randomisation lists according to the design of the trial and your personal requirements.

Sample Size Determination – 10’s, 100’s, or 1000’s? Will your trial demonstrate what it’s supposed to? Our statisticians have many years of experience dealing with all manner of sample size calculations for companies on both sides of the Atlantic.

Statistical Analysis Plan – From Phase I to IV, from asthma to virology, we have the in-house experience to design analysis plans that cover the complexities of a wide range of therapeutic areas.

SAS Programming - We consider our programmers to be the best in the business. That’s why we hired them. Again, experience and the desire to keep performing at their best are the key factors. Our SAS programmers use defensive style programming with multiple QC steps within every programme. This helps to ensure that the output is correct before it leaves their desktop. Further QC steps are advised, including 'double coding', to help guarantee that every output is 100% correct.

Report Writing - Statistical reports are prepared by our senior statisticians and quality controlled by a further statistician before being sent to the client. Naturally, we are in continuous contact with our clients at each draft stage, ensuring that the final product is one that they are truly happy with.

For more information on how we can be of help, please contact us.

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