Professional Services for Clinical Trials
Clinical data management services
From case report form (CRF) design to database lock, our clinical data managers ensure accuracy, compliance, and speed at every stage. With real-time validation, automated edit checks, and integrated reporting, we deliver database locks 2–3x faster than industry standards.
Clinical Data Management Process
Structured clinical data management process
Our clinical data management process begins early, at the protocol design phase, where we lay the basis for accurate and consistent data collection. To ensure full consistency and regulatory alignment, we follow a structured methodology:
Step 1
Study assessment and risk identification
We review the protocol, endpoints, data flows, and system landscape to identify risks. CRF design, safety reporting, laboratory data, randomization, and protocol deviation tracking.
Step 2
Data strategy and system alignment
We define standards, CRF structure, edit check logic, laboratory reference range setup, randomization interfaces, RBQM outputs, and reconciliation workflows aligned with regulatory expectations and sponsor requirements.
Step 3
Controlled execution and oversight
Data cleaning, query management, medical coding, reconciliation, review cycles, and annual laboratory reference range updates are performed under documented standard operating procedures (SOPs) and quality controls.
Step 4
Quality control and traceability
All data activities, including system setup, training materials, user manuals, and data changes are documented with full traceability, audit trails, and version control.
Step 5
Database lock and inspection readiness
We ensure the database is clean, reconciled, and fully documented prior to lock, including cleaning through discrepancy detection, query generation and resolution, formal EDC document lock, and EDC document export and provision to sponsor/sites with complete supporting documentation.
See how data flows within our unified clinical trial software
Core Capabilities
Our clinical data management capabilities
Our clinical data management services cover the full lifecycle of clinical data, including clinical database design, CRF design and database design, data cleaning in clinical trials, and database lock preparation.
Clinical database design
Clinical database design is critical for ensuring structured, compliant, and analysis-ready datasets aligned with CDISC standards. Our clinical data management teams develop databases optimized for accurate data capture and reliable downstream analysis. Through structured metadata and CDISC‑aligned standards, each build supports consistent data collection from first patient in to database lock.
- CRF design aligned with protocol objectives and CDISC standards, including SDTM-annotated pCRF creation and review
- Generation and validation of SDTM and ADaM datasets
- Electronic data capture (EDC) form design with controlled terminology and structured metadata, supporting consistent SDTM and ADaM dataset generation
- eCRF implementation optimized for high‑quality data entry
- Preparation and quality control of analysis-ready and submission-ready data packages
- Electronic protocol deviation log implementation for standardized tracking
Edit check implementation and validation
Clinical data management workflows integrate automated validation, data discrepancy detection, and structured data quality control to ensure every captured datapoint is clean, consistent, and review‑ready.
- Automatic edit and data discrepancy checks
- Data review, validation, and ongoing cleaning routines
- eCRF and EDC form completion guidelines for consistent data entry
Risk-based monitoring and source data review
Our approach combines risk‑based clinical data management, centralized monitoring in clinical trials, and source data review to ensure data quality, protocol compliance, and real‑time operational visibility.
- Risk‑based clinical data management
- Source data review (SDR) and cleaning
- Audit trail review (ATR)
- Data validation plan development
- Statistical data monitoring
- Centralized and remote monitoring in clinical trials
- Real‑time analytics, reporting, and CTMS‑driven feedback
eTMF setup and administration
We provide comprehensive electronic trial master file (eTMF) administration and TMF management services, ensuring structured trial master file setup, regulatory compliance, and continuous inspection readiness. With structured filing, role-based access control, and ongoing quality checks, eTMF remains inspection‑ready throughout the study lifecycle.
- eTMF folder structure setup
- eTMF training and trial‑specific user manuals
- eTMF administration during study start-up, conduct, and close-out. Quality control and ongoing system maintenance
- eTMF finalization
SCDM Innovation Award 2025
Society for Clinical Data Management
Wemedoo has been recognized by the Society for Clinical Data Management for innovation in clinical research, honored for our unified approach to clinical data management.
Technology
Technology-enabled data management
Our centralized data environment supports unified EDC, CTMS, and eTMF systems, enabling seamless data flow and real-time visibility across clinical trials.
Through automation, standardized structures, and streamlined data exchange, our team ensures faster cleaning, higher consistency, and more reliable decision‑making throughout the study lifecycle.
Leadership Perspective
Expert perspective
"High-quality clinical data doesn't happen by accident. It's the result of structured processes, intelligent automation, and continuous oversight from the first CRF design to final lock."
Regulatory Standards
Data quality and regulatory compliance
Clinical trial data must meet regulatory requirements under ICH GCP guidelines, FDA 21 CFR Part 11, EMA clinical trial regulations, and risk-based principles defined in ICH E6(R3). Our data management framework focuses on:
ALCOA+ data integrity principles
All data is Attributable, Legible, Contemporaneous, Original, and Accurate throughout the trial lifecycle.
CDISC standards (SDTM, ADaM)
Datasets are structured and annotated in accordance with CDISC SDTM and ADaM standards for regulatory submission.
Controlled change management
All system and process changes follow documented procedures with full version control and approval workflows.
Documented review processes
Data review cycles, query management, and cleaning activities are fully documented under applicable SOPs.
Risk-based data cleaning approaches
Cleaning activities are prioritized based on risk, focusing effort where data quality impact is highest.
Audit and inspection preparedness
Audit trails, TMF completeness, and data traceability are maintained to support regulatory inspections at any time.
All processes are supported by audit trails, role-based access control, and secure data handling practices
Our Clients
Who our clinical data management services are for
Biotech companies running early or late-phase trials
Mid-size pharma organizations seeking scalable clinical data management (CDM) support
Sponsors transitioning between CROs
Companies requiring database rescue or lock support
Academic or research institutions requiring structured oversight
Client Testimonials
Collaboration built on trust and innovation
Wemedoo's technology, expertise, and intimate engagement with our team in the development of the EDC, site/patient interface, and metric capabilities are unique. They provided insight and challenged the underlying assumptions to ensure the study's goals and objectives were clearly defined and the operating structure matched with the study's intent. Their system is not a one-size-fits-all and they adapt to the needs of the sponsor, sites, physicians, and the study requirements into a system that merges health information/data and can then become not only informative but actionable.
James Kuras
Vice President of Clinical Affairs and Operations at Centinel Spine
Wemedoo's cross-functional, integrated teams capture EDC set-up, go-live, data capture, data cleaning, and finally data analysis in a globally compliant fashion supporting trials in different geographies including the US. Their speed of addressing customer needs sets in my personal experience industry benchmark whilst keeping these data solutions lean and affordable. Besides the great proprietary systems they use, their integrated team approach with personal responsibility and honest commitment to targeting outcomes differentiates the Wemedoo team from other providers. Wemedoo only made Oxular's key initial trial, a device-drug trial possible, as based on some pre-work, the Wemedoo team could substantially adapt and update the first EDC ideas for a trial under a US FDA IND. The Wemedoo team worked extremely focused on familiarizing US trial sites and clinical CROs with the use of their system, which turned out to be a key success factor of the respective trial. The highly professional and up-to-date capabilities in data sciences were mirrored by customer-centricity and super fast timelines of integrating mandatory adaptations to the data systems.
Friedrich Asmus
Former Chief Medical Officer at OXULAR
All jobs, both large and small, are performed with the same dedication to quality, detail, innovative thinking, and rigor. It is always a pleasure to work with the Wemedoo team.
Georg Mathis, PhD
CEO at Appletree CI Group AG
Wemedoo embodies all the traits desired in a partner in the clinical trial industry – expertise, innovation, reliability, compliance, and attention to detail.
Martina Diminic Smetisko, DMD
Managing Director at Marti Farm Ltd
Their dedication to, and support of, our projects has resulted in clear quality deliverables. They are always there to answer any questions with expertise in a timely manner. I am looking forward to our next project together.
Volodymyr Stus, MD
Biopharmaceutics and Clinical Research Department Manager at Polpharma SA
Complex adaptive trials demand speed, precision, and system stability. With oomnia, Wemedoo's unified clinical trial software maintained continuous drug supply oversight, real-time data capture above 99%, and zero Randomization and Trial Supply Management (RTSM) dispensing errors throughout the study. The study reached database lock within 3 days after Last Patient Last Visit (LPLV), a direct result of integrated EDC–RTSM execution and proactive technical support. Wemedoo's technology and team responsiveness played a key role in meeting aggressive milestones.
Dhiraj Patel, Dr.
Director at Velocious Clinical Research
Experience across Phase I–IV clinical trials
Support for global, multi-site studies
Proven database lock acceleration (2–3x faster)
Expertise in CDM, risk-based monitoring (RBM), and eTMF operations
Resources
Clinical data management resources
Clinical Data Management
Wemedoo returns to Xraised episode 2 with unified data in focus
July 9, 2026
Artificial Intelligence in Clinical Trials: Balancing Innovation and Accuracy
June 24, 2026
A new scientific publication featuring Wemedoo researchers has been published in BMC Medical Research Methodology
June 24, 2026
Interoperability: The Missing Piece in Clinical Trial Efficiency
June 24, 2026
Mastering Protocol Deviation Management: The Smart Way Forward With ePDL
June 24, 2026
The CRO’s Guide to Winning Sponsor Trust
June 24, 2026
Key Takeaways from EUCROF25: AI, Integration, and CRO Challenges in Clinical Trials
June 24, 2026
Wemedoo Becomes an Associate Member of EUCROF
June 24, 2026
Across Global Alliance Selects oomnia as a Central Trial Infrastructure
June 24, 2026
Revolutionizing Clinical Trials: How Wemedoo is Accelerating Global Research
June 24, 2026
Why does unified data matter? Hear from Wemedoo at Swiss Biotech Day!
June 24, 2026
Wemedoo in The CEO Magazine: Fixing Clinical Trials
June 24, 2026
Wemedoo in Forbes: From Clinical Frustration to Real Innovation
June 24, 2026
New Era of Clinical Trials with oomnia®: Built for Complexity, Designed for Simplicity
June 24, 2026
From consent to compliance in patient-centric clinical trials
June 24, 2026
Reducing costs and standing out as a CRO
June 24, 2026
Dr. Nikola Cihoric elected to EUCROF AI Expert Group
June 24, 2026
Wemedoo announces strategic partnership with mediri to streamline imaging data management in clinical trials
June 24, 2026
Wemedoo’s innovation journey with oomnia on Xraised
June 24, 2026
Accessing better technology for clinical trials
June 24, 2026
The hidden cost of disconnected systems in biotech and the path to streamlined trials
June 24, 2026
Wemedoo receives SCDM innovator start-up of the year 2025 award
June 24, 2026
From device to database in 2 weeks made possible by Wemedoo and Withings
June 24, 2026
Wemedoo featured on BioSpace
June 24, 2026
Wemedoo joins Xraised again to share new perspectives
June 24, 2026
Wemedoo featured on AP News
June 24, 2026
Clinical trial trends in 2025
June 24, 2026
Why eClinical architectures have reached their limits, and a new category is emerging
June 24, 2026
Handling complex data in oncology trials
June 24, 2026
Fast database lock in a complex Phase III diabetes study
June 24, 2026
Why compliance risk increases in modular eClinical setups
June 24, 2026
The system architecture behind the data reconciliation challenge in clinical trials
June 24, 2026
What makes a clinical trial software truly unified
June 24, 2026
Solving MedTech trial complexity with the right technology partner
June 24, 2026
Top EDC software solutions for clinical trial teams
June 24, 2026