Clinical Trial Design

Start your clinical trial well at the design stage! Datapharm expertise can help ensure that your trial design is appropriate to your product and the stage of its development program.

Our experts in clinical trial management, data management, statistics, medical writing and pharmacovigilance work in close collaboration, ensuring all the critical elements are considered in the design of your clinical trial.

Clinical Trial Designs

Datapharm is experienced in a wide range of clinical trial designs including

  • Open label
  • Blinded (single or double)
  • Randomised
  • Parallel group
  • Crossover
  • Placebo-controlled and/or comparator
  • Retrospective
  • Adaptive

Outcomes in Clinical Trials

Our highly trained clinical trial experts can work with you to design your trial to evaluate outcomes appropriate to your product’s phase of development. We are experienced in designing early phase studies with pharmacokinetic, pharmacodynamic, biomarker and safety as outcomes. Equally for later phases of development, efficacy, health economics and quality of life outcomes can be analysed.

Statistical expertise in Clinical Trial Design

Datapharm recognises the importance of including expert statistical advice as early as possible in the design of clinical trials. Our statisticians are highly trained and experienced in a wide range of therapeutic areas at all phases of product development and have the most appropriate statistical methods and models at their fingertips.

Medical Writing and Clinical Trial Design

Datapharm Medical Writers are all medically or scientifically qualified and have a wealth of experience to contribute at the trial design stage.

Data management and Clinical Trial Design

Our highly trained team of data managers input to trial design at the early stages to ensure that the practicalities of methodology and assessment are addressed appropriately.