As the year draws to a close, it is a natural moment to pause, reflect, and acknowledge the path we have travelled. Being part of Linical’s data management team is a true source of pride. With more than two decades of experience, our team continues to meet the growing challenges inherent to oncology and rare‑disease clinical trials ensuring the integrity of the data entrusted to us.
Innovation and Expertise Driving Quality
In a landscape defined by rapid technological advancement, clinical data management stands at the intersection of innovation, deep expertise, and cross‑functional collaboration. Our team works closely with project management, clinical operations, medical management and biostatistics leveraging their insights to develop robust, protocol‑aligned solutions for every study.
This collaborative, multidisciplinary approach enables us to deliver essential tools and processes, including:
Protocol Aligned Data Capture Tools
By designing eCRFs grounded in recognized standards such as CDASH, we ensure that data collection aligns precisely with protocol requirements. This minimizes transcription errors and simplifies downstream analysis.
Integration and Harmonization of Multisource Data
Today’s trials incorporate a broad array of data stream: laboratory results, tissue samples, ECGs, imaging, eCOAs, eDiaries and more. Our platforms support the harmonization and automated reconciliation of these sources with eCRF data, ensuring both consistency and accuracy.
When budget limitations do not allow for full system integration, we implement reconciliation supported by automated programs, maintaining a high level of data quality.
Oncology Focused Tools and Solutions
The use of RECIST based calculators streamlines tumor response assessments across Target, Non Target, and New Lesions, offering standardized support for one of the most critical components of oncology trials.
Rigorous Oversight of Safety Data
Our continuous review of safety information ensures that clinically relevant findings are properly documented and reflected in key sections of the EDC, such as Medical History and Adverse Events.
Continuous Quality Control and Cross Sectional Consistency
We enforce cross‑form consistency checks, apply site‑specific laboratory ranges, and issue alerts for out‑of‑range or inconsistent values.
Additionally, Audit Trail Review remains a cornerstone of data integrity, allowing us to monitor user access, updates to key variables, and changes requiring oversight.
Direct Support for Clinical Teams
Through targeted programming within the EDC, we help clinical teams detect potential protocol deviations early, strengthening compliance and overall study quality.
Preparing for Increasingly Complex Clinical Trial Designs
Modern clinical protocols often feature adaptive methodologies, cohort‑based approaches, and dose‑escalation strategies. To meet these challenges, our team ensures that used EDC structures are flexible and prepared for ongoing amendments throughout the study lifecycle.
Data management also plays a key role in implementing systems for randomization and drug supply management and contributes strategically to the growing shift toward decentralized clinical trials (DCTs).
The Strategic Importance of CDISC Standards
The adoption of SDTM standards in final study databases is now essential for regulatory success. Linical’s Data Management experts ensure:
- Precise terminology
- Robust and standardized programming
- Comprehensive validation using tools such as Pinnacle 21
- The accurate development of Define.xml and associated submission documentation
These elements are critical for regulatory submissions to agencies such as the FDA, supporting a smooth and compliant review process.
Looking Ahead
Meeting the challenges of clinical research demands expertise, collaboration, and unwavering commitment. Linical’s data management team needs continue to grow alongside advances in science and technology.
Author:
Beatriz Rica, Manager, Clinical Data Management Western Region, EU