Alcedis GmbH
Alcedis is a full-service Contract Research Organization (CRO) specializing in clinical research, data management, biostatistics, regulatory affairs, and innovative digital solutions. The company supports pharmaceutical, biotech, and medical device industries in conducting efficient, compliant, and technologically advanced clinical trials. With a focus on modern digital tools like eCRF plugins, AI-powered data management, and decentralized trial technologies, Alcedis aims to enhance data quality, streamline processes, and accelerate drug development. The company emphasizes expertise, regulatory compliance, and innovative technologies to improve clinical research outcomes.
Industries
Nr. of Employees
medium (51-250)
Products
Modular eCRF plugin library
A collection of over 20 configurable eCRF plugins to extend EDC functionality for status tracking, queries, eSignatures, SDV support, validation overrides, drug accountability, monitoring, feasibility, training and remuneration.
AI-powered clinical free-text review software
An AI/NLP application that identifies and highlights relevant information in free-text fields of clinical data to accelerate reviews and reduce manual effort.
Hosted CTMS / EDC platform
A hosted clinical trial management and electronic data capture platform operated in a domestic datacenter, offering integrations with third-party solutions and modules for decentralized studies.
Modular eCRF plugin library
A collection of over 20 configurable eCRF plugins to extend EDC functionality for status tracking, queries, eSignatures, SDV support, validation overrides, drug accountability, monitoring, feasibility, training and remuneration.
AI-powered clinical free-text review software
An AI/NLP application that identifies and highlights relevant information in free-text fields of clinical data to accelerate reviews and reduce manual effort.
Hosted CTMS / EDC platform
A hosted clinical trial management and electronic data capture platform operated in a domestic datacenter, offering integrations with third-party solutions and modules for decentralized studies.
Services
End-to-end data management including DMP/DVP preparation, continuous data reviews, query management, data cleaning, locks and data transfer processes aligned with GCP and data protection requirements.
Statistical consulting and execution covering study design input, sample size calculations, SAP development, validated programming of TLFs, interim/adaptive analyses and CDISC-compliant dataset exports.
Safety management services including study-specific Safety Management Plans, case handling for AEs/SAEs/SUSARs, regulatory reporting and standardized medical coding for safety datasets.
Modular eCRF/EDC platform with a library of plugins to support CRF status tracking, queries, eSignatures, SDV, validation acknowledgements, drug accountability, monitoring, feasibility, training and remuneration workflows.
Software that applies AI/NLP to prioritize and extract key information from free-text clinical entries to accelerate data reviews and reduce manual workload.
Aggregation and analysis of anonymized EHR and registry data to support drug development decisions, RWE-based evidence generation and regulatory/market-access activities.
End-to-end data management including DMP/DVP preparation, continuous data reviews, query management, data cleaning, locks and data transfer processes aligned with GCP and data protection requirements.
Statistical consulting and execution covering study design input, sample size calculations, SAP development, validated programming of TLFs, interim/adaptive analyses and CDISC-compliant dataset exports.
Safety management services including study-specific Safety Management Plans, case handling for AEs/SAEs/SUSARs, regulatory reporting and standardized medical coding for safety datasets.
Modular eCRF/EDC platform with a library of plugins to support CRF status tracking, queries, eSignatures, SDV, validation acknowledgements, drug accountability, monitoring, feasibility, training and remuneration workflows.
Software that applies AI/NLP to prioritize and extract key information from free-text clinical entries to accelerate data reviews and reduce manual workload.
Aggregation and analysis of anonymized EHR and registry data to support drug development decisions, RWE-based evidence generation and regulatory/market-access activities.
Expertise Areas
- Clinical trial management
- Clinical data management and EDC operations
- Biostatistics and statistical programming
- Pharmacovigilance and safety reporting
Key Technologies
- Electronic Data Capture (EDC) / eCRF systems
- Plugin-based EDC extensions
- AI / Machine learning (NLP for free-text)
- Wearables and biosensor integration