In summary, our consulting services are designed to provide our clients with the strategic guidance, expertise, and support they need to navigate the complexities of the pharmaceutical industry successfully. With our deep industry knowledge, analytical rigor, and commitment to excellence, we empower our clients to achieve their business objectives, drive growth, and deliver value to patients and stakeholders alike.
Learn about the DRM Journey
Early Study Planning
Initial Phase
Recruitment
Documentation
Analysis & Archiving
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 depth 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
- 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
- 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
- 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
- Final statistical analysis
- Preparation of clinical study report, publications and scientific presentation
Previous
Next
Let's create an impact. Together.
Create a powerful environment for research and contact us today.