Clinical Investigations

Need a clinical trial for a medical device in Europe? Could your technology lead to an innovative medical application?

CERES can help you to access the European market!

A clinical trial is conducted to determine the safety and performance of a medical device according to Medical Device Regulation (MDR).

Our clinical trials enable you to…

… explore device feasibility
… investigate new technologies
… gain first-in-human experience
… support your application for CE approval
… gain approval for additional intended uses of your device

To achieve CE approval for high-risk medical devices such as long-term invasive applications or implants, clinical trials must be conducted unless the use of existing clinical data can be sufficiently justified. Depending on the goal of your study, various study designs could be useful, ranging from a single-center non-randomized trial to a multicenter, multinational, randomized, controlled trial.

Services we provide

Project & Study Management

  • Study justification and scientific advice
  • Study preparation and clinical investigation planning
  • Evaluation of the adequate study design, e.g. with respect to randomization, population, hypotheses, test-significance and follow-up schedule
  • Communication with competent authorities and ethics committees
  • Selection of qualified sites, core labs and clinical investigators
  • Ensure study progress and objective recruitment planning
  • Supervision of study committees and investigator meetings
  • Handling of the trial master file

Medical Writing: Planning & Design

  • Creation of the synopsis and the clinical investigation plan (CIP)
  • Determine sound in- and exclusion criteria
  • Patient informed consent documents in compliance with ethical principles
  • Compile investigator’s brochure (IB)
  • Preparation and registration of documentation components and case report forms (CRFs)
  • Inclusion of established questionnaires
  • Preparation of training documents
  • Writing of the clinical investigation report

Biometrics

  • Sample size justification and selection of population
  • Composition of study-hypotheses, aims and endpoints
  • Evaluation of the adequate study design
  • Create the statistical anaylsis plan
  • Specification of suitable statistical analyses and reporting
  • Evaluation with regard to performance and effectiveness
  • Descriptive and explorative data analysis
  • Interim analysis
  • Provide statistical interpretation of the results

Monitoring

  • Create appropriate monitoring plans
  • Establish data monitoring committee according to the investigational needs
  • Creation and maintaining of investigator site files
  • Initiation visits and trainings
  • Independent on-site and remote monitoring
  • Close-out monitoring visits

Vigilance

  • (S)AE management planning and (S)AE management
  • Supporting your clinical assessment of events
  • Handling case narratives, incl. description, reconstruction and related research
  • Preparing your reports to competent authorities and ethics committees
  • Organisation of clinical event committees (CEC meeting)
  • Selection of suitable specialists for CEC membership
  • Preparation of quarterly reports

Data Management

  • Planning of the data management
  • Data capturing and administration
  • Selecting electronic clinical data systems
  • Design eCRFs
  • Data collection
  • Handling queries, checks on plausibility, integrity and validity of data
  • Data review

Reporting

  • Regular monitoring reports
  • AE and complaint reporting
  • Reporting to EC
  • Statistical analyses reporting
  • Writing of the clinical investigation report

Benefits

modular, and transparent cost structure

efficient introduction of your products to the market

early return on your financial Investment

flexible use of our resources according to your requirements

additional expertise at the interface between user & manufacturer



Do you need more information?
Feel free to contact us.