Alcedis Platforms

Additional features

Scientific Advice

Provides early study planning, in-depth analysis, market evaluation, and feasibility testing to define scientific objectives.

Study Structure & Design

Develops regulatory concepts, conducts study forecasts, and creates reliable budget plans for optimal study setup.

Study Implementation

Manages the full study lifecycle from Phase I through regulatory approval, market access, and real-world evidence studies, ensuring successful execution.

Clinical Operations

Handles cross-functional management of all stakeholders during study conduct, including site selection, initiation, and ongoing support.

Regulatory Affairs

Establishes regulatory strategies, handles submissions to ethics committees and authorities, and ensures compliance.

Medical Writing

Develops high-quality scientific content for all study phases, including protocols, reports, and publications.

Data Management

Focuses on risk management and ensuring the highest level of data quality through robust processes and validation.

Pharmacovigilance

Provides permanent surveillance of patient safety throughout the study duration.

Biometrics

Offers advanced analytics and innovative methods for understanding and interpreting study data, including statistical analysis.

Monitoring

Deploys a global network of CRAs for both on-site and remote monitoring to ensure data quality and protocol adherence.

Oncology Research Specialization

Offers comprehensive services and innovative technical solutions specifically tailored for oncology trials.

Real-World Evidence (RWE) Expertise

Conducts and leverages real-world evidence studies to provide valuable insights beyond traditional clinical trials.

Technologies & IT Solutions (Alcedis Platforms™)

Multi-channel Data Integration Platform

A powerful central platform designed for seamless integration of diverse data sources within clinical trials.

Adaptive eCRFs (electronic Case Report Forms)

Provides highly customized, user-friendly, and secure electronic forms for dynamic data capture, reducing setup times.

Mobile Applications

Enables consistent and simple data capture and processing via mobile devices, including patient apps for PROs/COAs and reporting for project managers.

ePRO/eCOA (electronic Patient-Reported Outcomes/electronic Clinical Outcome Assessments)

Supports the electronic collection of patient and clinician-reported outcomes.

Wearables & Connected Devices Integration

Facilitates the integration of data from wearables and other connected health devices for comprehensive patient insights.

Telemedicine

Utilizes telemedicine functionalities to enable remote patient interactions and data collection, enhancing study reach and convenience.

Big Data Interfaces

Capable of handling and integrating large volumes and varieties of data from multiple sources.

AI Data Science

Develops AI-powered software products and solutions to analyze data, identify inconsistencies, and transform the efficiency and data quality of clinical research processes.

Integrative Platforms

Offers a holistic platform approach that combines various functionalities to streamline clinical research workflows.

Agile Conduct

Features a flexible platform that allows for near real-time modifications and additions to study protocols, accelerating study setup and adaptation.

Plugins

Provides robust, off-the-shelf extensions for common and important processes, reducing setup timelines and maximizing cost efficiency.

Secure Data Hosting

Ensures data safety through in-house cloud computing centers in Germany, adhering to strict security standards.

General Capabilities & Values

Data-Driven Approach

Emphasizes organizing clinical trials around efficient data collection, analysis, and utilization to accelerate progress in human health.

Digital-First Clinical Research

Pioneers the shift towards digital solutions, combining traditional CRO services with disruptive technologies for added value.

360° Clinical Research

Offers a comprehensive approach that covers all angles and phases of clinical trials.

Customer-Oriented Approach

Flexibly adjusts services and processes to meet specific client needs and visions, ensuring tailored solutions.

Quality and Compliance

Adheres to high international standards and certifications (e.g., EU MDR, FDA, ISO, GDPR) for regulatory and data security compliance.

Expert Teams

Leverages experienced and highly motivated experts to ensure the success of every study.

Sustainable Partnerships

Aims to build long-term, trust-based relationships with clients.