CRO Services


Project Management
We offer a structured approach while ensuring quality and flexibility, readily responsiveness, and transparency in:

  • Consulting on the planning, development, and conduct of clinical investigations 
  • Consideration and creation of study concepts
  • Design and developing of study protocols
  • Design of (e)CRFs, maintenance and monitoring of databases, data management
  • Quality assurance measures, SOPs, Gap-analyses
  • Support the sponsor in or selecting appropriate investigational sites
  • Consulting and assistance with clinical trial agreements and budget planning
  • Initiation and training of investigational sites
  • Site support & management
  • EU Authorized Representative

 

Regulatory Affairs
Clinical studies are subject to regulatory requirements (e.g., DIN EN ISO 14155, EU MDR 2017/745, MPDG). We provide comprehensive advice on regulatory requirements, and full Regulatory Affairs service, including:

  • Consulting on approval procedures
  • Review and support for study protocols and required study documents, preparation and collection for the submission
  • Prepare application and execution of submission procedures to ethics committees and relevant federal authorities (e.g., BfArM) for CTs/studies, IITs, PMS
  • Issue and review of patient information/informed consent form (ICF)
  •  and review of general study documents (logs, templates, worksheets)
  • Creation and maintenance of eTMF for national and international sponsors
  • Post-market surveillance with reporting
  • Data protection, especially protection of study subjects’ data in accordance with GDPR (EU-GDPR) and international regulations.

 

  • Full Safety Reporting Service – documentation, support, and required reporting of Serious Adverse Events (SAE), vigilance

 

  • Compassionate use 

 

 

Monitoring / Auditing
With our experienced clinical research team (CRAs), we ensure that clinical trials are conducted in accordance with the applicable regulatory requirements (e.g., EU Regulation 2017/745 [MDR], ISO 14155, and ICH-GCP) and the approved study protocol. Data integrity is ensured by careful source data verification.

  • Issuing of monitoring plans and SOPs
  • Pre-study-Visit, Initiation, On-site monitoring and On-site management, Close-out Visit
  • Remote monitoring
  • Risk-based monitoring
  • Centralized monitoring
  • Project specific training
  • Ensuring compliance for safety-related reporting to the sponsor
  • Preparation and support for investigational sites and sponsor for and during inspections and audits
  • Quality audits, pre-inspection audits

 

  • Clinical Field Services