Proper study planning requires more than just technical know-how. To define study objectives and to choose adequate parameters for measurements and evaluation, medical knowledge as well as biometric skills are essential. Correct sample size calculation, a sound statistical analysis plan, and the development of well-structured CRFs also require input by seasoned experts.

MEDIDATA offers expert services for all aspects of study planning and preparation. We outline study plans, develop study protocols and related documents (statistical analysis plans, CRF [both paper and EDC], patient information, etc.), manage randomization procedures, and control the printing process.

Our experienced project managers and CRAs also routinely cover ethics and regulatory pre-study activities.