Range of services

We offer the complete management of a study over all phases of the project or assist you as needed.

  • Feasibility assessment
  • Recruitment planning
  • Creation of the trial plan
  • Selection of centres and clinical investigators
  • Study preparation and justification
  • Planing and conduct of the submission procedure
  • Communication with authorities and review boards
  • Recruitment
  • Remuneration of doctors
  • Creation of the Data Management Plan (DMP) and Data Entry Guideline (DEGL)
  • CRF design in paper, our own eCRF or as hybrid
  • CRF in all languages
  • Programming of the study data base (with all imaginable features such as plausibility, completeness and validity checks, trail, tracking, online or offline compare)
  • Set-up of the OCR software for internal or external forms
  • Set-up of the study website
  • Printing of the documents and shipment to the participants
  • Account allocation to users with different rights
  • Capturing of the response and timely data entry (single or double)
  • Data maintenance
  • Creation, distribution and tracking of queries (paper and/or electronic)
  • Programming of status reports (available via eMail at any time for our customers)
  • Reports to authorities and the sponsor (AE/SAE/AR/SAR-Handling)
  • Hotline for field force staff and centres
  • Archiving in compliance with legal provisions
  • Creation of the monitoring plan
  • Provision of Clinical Trial Managers (CTA) / Clincal Reasearch Assistants (CRA)
    • Own employees for small studies
    • Recruitment of freelancers for larger or international studies
  • Assessment of the most suitable type of study
  • Elaboration of the study hypothesis, aims and variables
  • Estimation of the sample size and observation period
  • Determination of the statistical evaluation procedures and methods
  • Randomisation
  • Preparation of the statistical analysis plan (SAP)
  • Coding (e.g. MedDRA, ICD, WHO-DD or customer specific coding)
  • Statistical analysis
  • Single-site and subgroup analysis
  • Meta analysis
  • SAS programming

Creation of documents for authorision studies of pharmaceuticals or the certification of medical devices as well as studies for after market approval or marketing (PMCF studies with medical devices, Phase IV studies with medical devices)..

This includes:
  • Study protocols, study plans, test plans, surveillance plans (depending on study phase and type)
  • Documentation forms (CRF, forms adverse events, adverse reactions etc.)
  • Patient information / informed consent
  • Requests to authority, correspondence
  • Study reports, including Clinical Study Reports (CSR) according to ICH-Guidelines
  • MedDRA coding
  • Case report
  • Medical Documentation
    • in context of clinical trials or authorisation procedures of pharmaceuticals in compliance of the CP, MRP und DCP procedures (Common Technical Document (CTD))
    • in context of clinical trials or authorisation procedures of medical devices (conformity assessment, CE - technical documentation in accordance with the EU Regulation on medical devices)
  • Creation of dossiers for the benefit assessment by the German Federal Joint Committee (G-BA), HTA (Health Technology Assessment)

Creation of documents on pharmaceuticals or medical devices for the public or for individual groups of people or professionals.

This includes:
  • Publications
  • Presentations for medical congresses
  • Abstracts and posters
  • Handouts
  • Single site analyses
  • Translations
  • Use and expert information
  • Brochures