🇨🇭 Swiss Data Privacy & Precision

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.

ISO 27001 SOC 2 FDA 21 CFR Part 11 GDPR & HIPAA

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
Recognition

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.

Automation Centralized data environment Integration with EDC / CTMS / eTMF
Laboratory data management Data integration and data flow management

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."
Urosh Vilimanovich, PhD
Chief Customer Officer

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

Centinel Spine logo
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

Oxular logo
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

Appletree CI Group AG logo
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

Marti Farm Ltd logo
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

Polpharma SA logo
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

Velocious Clinical Research logo
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

Proven Track Record

Proven experience in clinical data management

Explore Oomnia

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

Blog

Wemedoo returns to Xraised episode 2 with unified data in focus

July 9, 2026

Blog

Artificial Intelligence in Clinical Trials: Balancing Innovation and Accuracy

June 24, 2026

Blog

A new scientific publication featuring Wemedoo researchers has been published in BMC Medical Research Methodology

June 24, 2026

Blog

Interoperability: The Missing Piece in Clinical Trial Efficiency

June 24, 2026

Blog

Mastering Protocol Deviation Management: The Smart Way Forward With ePDL

June 24, 2026

Blog

The CRO’s Guide to Winning Sponsor Trust

June 24, 2026

Blog

Key Takeaways from EUCROF25: AI, Integration, and CRO Challenges in Clinical Trials

June 24, 2026

Blog

Wemedoo Becomes an Associate Member of EUCROF

June 24, 2026

Blog

Across Global Alliance Selects oomnia as a Central Trial Infrastructure

June 24, 2026

Blog

Revolutionizing Clinical Trials: How Wemedoo is Accelerating Global Research

June 24, 2026

Blog

Why does unified data matter? Hear from Wemedoo at Swiss Biotech Day!

June 24, 2026

Blog

Wemedoo in The CEO Magazine: Fixing Clinical Trials

June 24, 2026

Blog

Wemedoo in Forbes: From Clinical Frustration to Real Innovation

June 24, 2026

Blog

New Era of Clinical Trials with oomnia®: Built for Complexity, Designed for Simplicity

June 24, 2026

Blog

From consent to compliance in patient-centric clinical trials

June 24, 2026

Blog

Reducing costs and standing out as a CRO

June 24, 2026

Blog

Dr. Nikola Cihoric elected to EUCROF AI Expert Group

June 24, 2026

Blog

Wemedoo announces strategic partnership with mediri to streamline imaging data management in clinical trials

June 24, 2026

Blog

Wemedoo’s innovation journey with oomnia on Xraised

June 24, 2026

Blog

Accessing better technology for clinical trials

June 24, 2026

Blog

The hidden cost of disconnected systems in biotech and the path to streamlined trials

June 24, 2026

Blog

Wemedoo receives SCDM innovator start-up of the year 2025 award

June 24, 2026

Blog

From device to database in 2 weeks made possible by Wemedoo and Withings

June 24, 2026

Blog

Wemedoo featured on BioSpace

June 24, 2026

Blog

Wemedoo joins Xraised again to share new perspectives

June 24, 2026

Blog

Wemedoo featured on AP News

June 24, 2026

Blog

Clinical trial trends in 2025

June 24, 2026

Blog

Why eClinical architectures have reached their limits, and a new category is emerging

June 24, 2026

Blog

Handling complex data in oncology trials

June 24, 2026

Blog

Fast database lock in a complex Phase III diabetes study

June 24, 2026

Blog

Why compliance risk increases in modular eClinical setups

June 24, 2026

Blog

The system architecture behind the data reconciliation challenge in clinical trials

June 24, 2026

Blog

What makes a clinical trial software truly unified

June 24, 2026

Blog

Solving MedTech trial complexity with the right technology partner

June 24, 2026

Blog

Top EDC software solutions for clinical trial teams

June 24, 2026

Frequently asked questions (FAQ)

What are clinical data management (CDM) services?

Clinical data management services involve the structured collection, cleaning, validation, and preparation of clinical trial data to ensure accuracy, compliance, and readiness for analysis and submission.

What does a Data Management Plan (DMP) include?

A DMP defines data handling procedures, validation checks, reconciliation workflows, roles and responsibilities, and database lock procedures for a clinical trial.

How do you ensure data quality in clinical trials?

Through edit checks, structured query management, reconciliation processes, documented reviews, and risk-based data cleaning strategies aligned with ICH GCP.

Do you support database lock preparation?

Yes. We conduct pre-lock reviews, ensure query resolution, verify reconciliation completion, and document lock procedures to support inspection readiness.

What are eTMF management services?

eTMF management services include the setup, configuration, administration, and ongoing maintenance of an Electronic Trial Master File system for clinical trials. Wemedoo provides comprehensive eTMF services including TMF structure design, document filing, completeness tracking, and inspection readiness preparation.

What does Wemedoo eTMF setup and administration include?

Wemedoo eTMF setup services include TMF structure design based on the TMF Reference Model, document indexing and filing, user access configuration, automated workflows, completeness tracking dashboards, quality control reviews, and regulatory inspection preparation for ICH GCP and local requirements.

How does professional eTMF administration improve inspection readiness?

Professional eTMF administration ensures documents are filed correctly, completeness metrics are tracked in real time, quality gaps are identified proactively, and the TMF is always ready for regulatory inspections. This reduces the risk of findings during audits and inspections.

Can Wemedoo eTMF services adapt to different trial phases?

Yes, Wemedoo eTMF services are tailored to each trial phase from startup through closeout. The service scales with the trial's document volume and complexity, with workflows adjusted for site activation, ongoing conduct, and study close-out requirements.

What TMF standards does Wemedoo follow?

Wemedoo follows the DIA TMF Reference Model for document classification, ICH GCP guidelines for essential document requirements, and local regulatory standards. The eTMF service ensures compliance with 21 CFR Part 11 and applicable data integrity requirements.

What is risk-based monitoring in clinical trials?

Risk-based monitoring (RBM) is a clinical trial oversight approach that uses centralized data review and statistical methods to focus monitoring activities on the highest-risk areas. Wemedoo provides RBM services including centralized monitoring, source data review, key risk indicator tracking, and site risk assessment in accordance with ICH E6(R2) and ICH E6(R3).

How does risk-based monitoring improve clinical trial quality?

Risk-based monitoring improves quality by identifying data integrity issues, protocol deviations, and safety signals earlier through centralized data analytics. This targeted approach detects problems that traditional 100% source data verification often misses, while reducing monitoring costs and site burden.

What is source data review in clinical trials?

Source data review (SDR) is the process of verifying that clinical trial data recorded in the EDC system matches the original source documents at investigator sites. Wemedoo's SDR services include remote source data verification, targeted on-site reviews, and centralized monitoring analytics.

How does centralized monitoring reduce clinical trial costs?

Centralized monitoring reduces costs by replacing a significant portion of on-site monitoring visits with remote data review and analytics. This approach reduces travel expenses, enables more frequent data oversight, and allows monitors to focus their on-site time on critical findings rather than routine verification.

Does Wemedoo RBM comply with ICH E6(R3) guidelines?

Yes, Wemedoo risk-based monitoring services are designed to comply with ICH E6(R2) and the updated ICH E6(R3) guidelines, which emphasize risk-proportionate monitoring, quality by design, and centralized approaches to clinical trial oversight.