Study planning

Study planning

Crucial details are already determined in the planning phase preceding a trial. Precisely coordinating the details of the study design, target criteria, sample size and other parameters can shape the optimal procedure that will offer the best chances of success to ensure a cost-efficient and timely conduct of your trial.

Ask our project managers for detailed advice on how to efficiently plan your trial to avoid any unwanted surprises.

  • Determination of the study design
  • Biometrical sample size calculation
  • Creation of the protocol in line with the applicable regulations (ICH-GCP, AMG and GCP-V)
  • Preparation of study documents (case report form, patient information sheet, informed consent form, worksheets, diaries, etc.)
  • Obtaining of clinical trial insurance
  • Performance of feasibility studies
  • Recruitment of suitable trial sites
  • Packaging of the investigational drugs
  • Preparation of the site files
  • Planning of monitoring

Study planning

During the planning stage of non-interventional studies (NIS), all key aspects that contribute to a cost-efficient and rapid study conduct are determined.

Ask our experienced team for detailed advice on how to determine the best procedure for your project.

  • Determination of the study design
  • Biometrical sample size calculation
  • Preparation of study documents (case report form: paper CRF or eCRF, patient information sheet, informed consent form, worksheets, diaries, etc.)
  • Planning of monitoring
  • Selection of physicians to involve

Study planning

Prior to performing trials in the medical device sector, it must be clarified whether clinical trials are, in fact, necessary. Literature reviews are often sufficient. After evaluating all available options, the best procedure for ensuring a cost-efficient and prompt market launch of your medical device is determined.

Ask our medical device specialists for detailed advice on how to efficiently plan your trial to avoid unwanted costs and delays.

  • Evaluation of the prevailing circumstances (§§20-23a MPG, §23b MPG)
  • Advice on how to conduct the CE conformity assessment procedure
  • Creation of the protocol according to valid regulations (product-specific ISO standards, ISO 14155, MPG, MPKPV, MPSV)
  • Preparation of study documents (case report form, patient information sheet, informed consent form, etc.)
  • Obtaining of clinical trial insurance
  • Recruitment of suitable trial sites
  • Preparation of the site files
  • Planning of monitoring
  • Logistics planning