Empowering Clinical Trials

...to make the impossible possible.
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Moving trials forward. On time. By Experience.

As a full-service CRO, we accompany studies from the first idea until the final results. Our holistic approach is effectively enhanced by our digitally supported procedures. This results in significant advantages arising through synergies between our experts, our partners, physicians and patients.
Clinical Operation
Cross-functional management of all stakeholders during study conduct
Regulatory
Handling submissions to obtain approvals by authorities and ethic committees
Medical Writing
Medical expertise creating scientific content in all study phases
Data Management
Risk management by ensuring highest level of data quality
Pharmacovigilance
Permanent surveillance of patient safety
Biometrics
Understanding data with advanced analytics and innovative methods
Monitoring
Global network of CRAs for on-site and remote monitoring

Learn about the Alcedis Journey

Early Study Planning

It all starts with a vision, a hypothesis, an objective - The foundation for a successful study is laid when experts from all diciplines and departments at Alcedis unite for study planning.
  • In deepth analysis, feasibility and market evaluation
  • Sample size calculation and study design
  • Creation of first-step documents like study designs, synopsis or research grant applications
  • Writing of study protocols, observational plans and other required documents (ICF etc.)
  • Choosing appropriate study procedures
  • Study course forecasting and reliable budget plans

Initial Phase

Within the initial phase we take responsibility for the preparation of all set- up activities in time. This contains regulatory requirements, study materials, site preparation and implementing the technical environment on Alcedis Platforms™.
  • Submissions to ethic committees and notifications of authorities
  • Creation of study material and plans for Data Management, Risk-Management, Statistical Analysis or Monitoring
  • Set-up of drug supply, sample management and laboratories.
  • Customization of eCRF, choice of Tech-Ons and interfaces, set-up to additional data sources via Alcedis Platforms™.
  • Site feasibility, identification, contracting, training and initiation.

Recruitment

As the recruitment phase is crucial for the course of the study, we make sure that everything is on schedule and sites receive any support needed.
  • Intensive site support and helpdesk
  • Early data reviews after first patients are included
  • Constant safety monitoring
  • Intensified reporting and communication with sponsor and other stakeholder

Documentation

Reliable performance throughout the entire study duration - compliant and on-time. We deliver wide ranging services to ensure data quality, safety and smooth study and site administration.
  • Continuous data monitoring, coding, reviews and query management
  • AE handling, reconcilations and pharmacovigilance reportings
  • Conduct of on-site visits and remote monitoring
  • Investigator remuneration and study budget control
  • Organization of investigator meetings, DSMBs or steering committee meetings
  • Gaining first insights by interim analysis

Analysis & Archiving

After final database closure we follow up with processing and analysis of collected data for required study reporting, before CRO activities are succesfully completed in course of all archiving procedures.
  • Final statistical analysis
  • Preparation of clinical study report, publications and scientific presentations
  • Archiving of TMF documents and CRF provision for sites

Let's create an impact. Together.

Create a powerful environment for research and contact us today.
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