Data & Technology Solutions for
Clinical Trials
Data & Technology Solutions
Turning Data into Decisions
At Astrum, we believe data is the true currency of drug development. The speed, quality and integrity of your data define not only regulatory approval but also investor confidence.
Our data and technology solutions ensure that every dataset is traceable, regulator trusted and investor relevant, supporting studies from first in human through post marketing and non interventional research.
Why It Matters
Driving value at every critical milestone of your clinical journey.
Investor Confidence
Data structured to strengthen fundraising, licensing and exit milestones.
Regulatory Alignment
Compliance with ICH-GCP, CDISC and 21 CFR Part 11 standards, validated through FDA, EMA and ANVISA inspections.
Operational Efficiency
Centralised oversight and intelligent automation that accelerate timelines.
Data Integrity
Traceable, inspection-ready datasets that reduce risk and build trust at every stage.
Our Core Capabilities
Biostatistics & Programming
- Statistical consultancy from design through reporting, including randomisation, sample-size estimation and SAP development.
- Programming with standardised TFL libraries and macros to ensure efficiency and consistency across studies.
- Estimand strategies, adaptive designs and DSMB support for robust scientific validity and regulatory transparency.
- PK/PD analytics and dose-selection modelling delivered through expert partner networks, supporting Astrum’s early-phase expertise.
- Strategic input for regulatory and investor discussions, ensuring data supports both compliance and capital milestones.
Data Management
- Rapid, efficient database builds across multiple validated systems (Medrio, Viedoc, Medidata Rave).
- Built-in edit checks and query-resolution workflows that detect and correct errors in real time.
- Integration with ePRO/eCOA and central laboratories for streamlined data flow.
- Global libraries based on CDASH standards for consistency and faster start-up.
- AI-assisted discrepancy detection and data-reconciliation tools for improved accuracy.
- Query-management dashboards providing real-time visibility of data status and site performance.
- Compliant data handling aligned with 21 CFR Part 11, GDPR and other regional frameworks.
Central Monitoring & RBQM
- KRI-based central oversight built on statistical summaries and trend analytics.
- AI-supported risk detection and visualisation dashboards enabling proactive intervention.
- Evolving towards a fully integrated risk-based quality management (RBQM) framework that unifies data, monitoring and operational insights.
Medical Writing
- Clinical and regulatory documentation: protocols, CSPs, CSRs, IBs and SAPs.
- Scientific communications including posters, abstracts and peer-reviewed publications.
- Integrated medical writers working closely with Biostatistics and Data Management to ensure accuracy, clarity and compliance.
eClinical Solutions
- Unified digital ecosystem combining EDC, ePRO, eTMF, CTMS and oversight platforms.
- Scalable architecture tailored to Phase I, Phase II–IV and Non-Interventional Studies.
- Real-time dashboards and remote-monitoring capabilities supporting data-driven decision-making.
TMF & Records Management
- Expert-led Trial Master File setup, maintenance and inspection readiness.
- Controlled, compliant handling of essential documents for seamless audits and submissions.
Why Astrum
Integrated Phase I–IV and NIS expertise, linking early clinical data with late-phase and real-world insights.
Proven track record
more than 1,000 studies supported with regulator-ready datasets.
Technology-ready
a unified data environment connecting science, operations and investors.
Strategic integration
data that strengthens both clinical outcomes and funding narratives.
Let’s Talk Data
Ready to make your data work harder for you?