The design of the Clinical Trial is a critical step in implementing a successful clinical research program. Poor trial design or planning is the main cause of issues or errors occurring in clinical trials. No amount of statistical methods can rescue poor trial design. Investing in clinical trial design services enables you to maximize the value of your overall investment. Our 40 years of experience will help in providing tailored clinical trial design services specific to your research goals. We can recommend appropriate trial designs ranging from simple single end point designs to more sophisticated Bayesian adaptive designs.
We’ll develop clinical study plans and protocols and provide the knowledge and support that is required to best address your specific business goals. Not only do we leverage our extensive experience, track record and current insight to design your protocol but we use a collaborative approach to providing clinical trial design services that helps us define challenges, opportunities, data sets, assumptions, benefits, risks and validations for your team.
The depth of experience from our team of experts will help you realize the full potential of your protocol.
The objective of clinical trials is to establish the effect of an intervention. There are many aspects that must be considered when designing clinical trials; the first is being able to clearly define a primary clinical research question. Other fundamental issues include minimizing variation, randomization and stratification, blinding, placebos, selection of a control group, selection of the target population, the selection of endpoints, sample size, and planning for interim analyses among others.
There are many issues to consider when designing a clinical trial and our trial design experts will design your study to answer your research questions with high confidence. Some of the clinical trial design services we provide include:
An approach to clinical trials popularized in the mid 1990’s, Adaptive-By- Design allows for adjustments and modifications during the clinical trial, making the study responsive in real-time. Increasingly popular, Adaptive design helps sponsors determine if the therapy is going to fail, and if so, to help it fail early, shortening timelines and reducing costs, eventually helping to expedite and improve efficiencies and increase a trial’s probability of success.