Case study

Clinical Data Integration & Reporting

From vendor-dependent reporting to automated daily data access.

Anonymized pharmaceutical client • 4 clinical studies • 2 external EDC vendors

Clinical studies

EDC vendors

3 weeks

Before

2–4 hrs

After

The Challenge

A slow and costly reporting process across multiple external EDC environments

Four clinical studies were hosted across two external EDC vendors. Custom reports and exports across multiple domains required vendor tickets, with development and validation typically taking around three weeks.

New reporting requirements could trigger Change Orders of up to €7,500 per report, and urgent Data Management requests were constrained by vendor timelines. Manual Excel-based extraction and downstream processing added further operational effort.

Typical turnaround

~3 weeks

Up to / custom report

€7,500

Core issue: reporting capability depended on external vendor capacity rather than internal Data Management needs.

The Solution

Automated clinical data integration with a controlled reporting layer for the Clinical Data Management Team

External EDC environments

2 vendors / 4 studies

Secure API access

Study-specific extraction

Python / JSON automation

Nightly run at 02:00

Azure SQL data layer

Centralized processing

CDM team reporting

Queries & custom reports

Ready only for the CDM-Team

over DTM SQL Query Reporter

Development & deployment approach

Legacy MS Access queries and reports were analyzed and migrated.
SQL Server Express was used for development and testing.
Reconciliation and controls ensured data integrity before go-live.
Azure SQL hosted the production environment with script adaptation.
Production ran as an automated nightly pipeline.

02:00 automated extraction → processing, import & reconciliation → updated data available within 2–4 hours

Data Integrity, Security & Validation

Controls embedded across the automated downstream reporting pipeline

Data integrity

Completeness checks
Source-to-SQL reconciliation

Process control

Automated logging
Error handling & monitoring

Security

Restricted access
Secure credential handling

Validation & continuity

Change control & testing
Backup & recovery

EDC remained the system of record; Azure SQL served as the controlled downstream reporting and analytics layer.

Business Impact

Faster access, lower external reporting dependency and controlled self-service for Clinical Data Management

Before→After

~3 weeks2–4 hours

Vendor ticket & Change OrderAutomated nightly pipeline

Up to €7,500 / custom reportVendor report cost avoided for covered requests

Manual Excel extractionAutomated data integration

Vendor-dependent reportingControlled self-service reporting for the CDM Team

Clinical data access became an automated, controlled and scalable internal capability for the Clinical Data Management Team.

Case study

eCRF Building as Data Team Lead

Protocol to validated eCRF — CDISC-compliant specification and Go-Live

ProtocolSpecificationCDISC annotationBuildTestingGo-Live

Situation

Responsible as Data Manager Lead for the entire eCRF setup team.
Translating the study protocol into a structured specification.
Ensuring compliance with CDISC, internal SOPs and WIs through proper annotation.
Extensive testing, stakeholder alignment and change documentation required, including safety pages and coding dictionaries.

Solution

Led the team in designing and structuring the eCRF according to the protocol.
Ensured all specifications were annotated to CDISC standards.
Ran multiple test cycles to validate functionality and usability.
Organized a pre-screen review with the client and main PIs to align early.
Documented all changes and edit checks for full traceability.

Results

System approved for Go-Live after successful setup and validation.
Seamless transition to the operational phase with minimized risk.
Reliable data collection with robust edit checks and clear documentation.

Case study

ePRO Data Capture without an Online System

Non-interventional study with ePROs — licensing restricted online hosting

eCRFePROPaper ePRODouble Data Entry

Situation

An ePRO system was required for data collection within the study.
Licensing restrictions did not permit hosting the ePRO online.
An alternative was needed for efficient entry, management and verification.
Coordinating multiple analysts and monitoring accuracy was critical.

Solution

Developed a custom MS Access database as a secure, structured entry platform.
Coordinated analysts for a systematic data input approach.
Implemented double data entry to increase accuracy.
Compared independent entries to identify discrepancies early.
Continuously monitored progress against quality standards and timelines.

Results

Guaranteed a high level of data quality throughout the study.
Structured entry, systematic verification and oversight ensured reliable data.
Secure and efficient offline alternative supporting study integrity.

Case study

Site Recruitment & Contract Negotiation

Observational study — multicenter setup across Germany

Cover letterCDANegotiationCTAISFSIVeCRF

Situation

Multicenter observational study in Germany requiring efficient site recruitment.
Communication with clinics and private practices, contracts and financial terms.
Each center had different contractual expectations and compensation requirements.
Tracking contract status across email and phone was complex.

Solution

Adapted CDA and CTA templates to the specific needs of the study.
Contacted centers directly by email and phone to clarify open questions.
Negotiated financial terms: start-up, patient registration, visit documentation, query resolution.
Handled hospitals and private practices individually for fair compensation.

Results

Accelerated recruitment with clear agreements in place.
Smooth contract negotiations with both parties aligned on financial terms.
Faster study setup and better oversight of contract and financial status.

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