Reliable data management, streamlined by smart systems

Data Management Services

At Alcedis, Data Management is more than a support function—it’s a central pillar of study success. Our team ensures that clinical data is accurate, complete, and accessible, from initial setup through to database lock. What sets us apart is the deep operational integration between our experienced data managers and our in-house developed systems, enabling agile workflows, automated processes, and real-time oversight.

  • Creation and maintenance of Data Management Plans (DMP) and Data Validation Plans (DVP)
  • Setup and update of project-specific data documentation
  • Continuous data reviews throughout the clinical trial lifecycle
  • Query management and data cleaning in close cooperation with sites
  • Support for Medical Review and Risk Management processes
  • Soft locks, database freezes, and final hard lock procedures
  • Preparation of Validity Review Reports and Data Management Reports
  • Secure data transfer and sponsor communication
System-Integrated

Our proprietary platform enables seamless interaction between teams and tools—reducing manual overhead and speeding up decision-making.

Review-Ready Data

Automated validation and targeted data checks ensure data plausibility at every stage of the study.

Real-Time Oversight

Live dashboards and monitoring allow for proactive issue detection and streamlined query resolution.

Compliance

All data handling processes follow GCP, GDPR, and audit trail standards—built directly into our software infrastructure.

Documented Precision, Updated with Purpose

  • Data management at Alcedis begins with structured documentation: from Data Management Plans to Data Validation Plans and beyond. These are living documents, continuously updated to reflect protocol changes, site behavior, and risk assessments.
  • In addition, our teams contribute to broader quality frameworks—such as Risk Management Plans and Validity Review Reports—ensuring that data flows are not only documented but strategically aligned with project goals.

Overcoming Complexity in Data Management

High-volume data, tight timelines, regulatory demands—data management must navigate it all. Here’s how we meet the challenge head-on:

  • Seamless System Integration: Our in-house software ecosystem enables unified workflows between data entry, monitoring, and medical review. This ensures that processes like query generation, signature tracking, and freeze preparation are not only faster—but fully traceable.
  • Efficient Query Handling: We prioritize lean, high-quality query cycles: fewer unnecessary queries, quicker turnaround, and closer alignment with sites. Query handling is embedded within our eCRF tools to maximize efficiency.
  • Continuous Data Review: Instead of waiting for study close-out, we maintain ongoing review cycles—flagging issues early, validating data in real-time, and aligning with medical and risk reviewers throughout. This ensures clean, actionable datasets long before database lock.

"We are collaborating with Alcedis for many years in several indications and as such in some local oncology studies. I believe one of the success factors for Alcedis is their high commitment and the hard work they bring into assigned projects. Besides great expertise in clinical research, another sweet spot is definitely their IT solutions for innovative data capture in clinical studies."

Dr. Lars Mühlenhoff
AstraZeneca, Director Medical Affairs Oncology

"In our collaboration I experience Alcedis as a very cooperative and flexible partner. The internal organisation is very good, which one can see for example in the harmonous and efficient communication between the departments involved. Tasks were always done punctually and in good quality. The project-team was always very open during the creation-process and supported us with good advice, based on the past experience. I am very happy to be working with such an experienced and well-tuned CRO-team. The cooperation is really fun and I would definitively recommend Alcedis!"

Dr. Susanne Oesch
Bayer, Medical Advisor

Latest Whitepaper

Our summarization of EUCROF's propositions on leveraging remote source data verification and reviews (rSDV/rSDR) in clinical trials. Gain insights and recommendations for seamless integration, ensuring data consistency and participant privacy while reducing site burden.

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