Clinical data management

Our clinical data management services include

eCRF design and creation of annotated CRFs
Database design, programming of data entry masks and edit checks
EDC and double data entry
Transfer and integration of external data (e.g. laboratory)
Coding (adverse events, diagnosis and concomitant medication)
Data validation and query management
Quality control and database lock
(Blind) Data Review
Reconciliation of SAE data
Creation of status reports and statistics
Preparation of final statistical reports

Recording, understanding and communicating clinical data

Clinical data management refers to processes that serve to manage, use and record data and is a general term for a wide variety of tasks.
As a branch of medical data management, clinical data management deals with the review and coding of data collected in research studies.

Data protection and transparency are paramount

Due to the continuous change in legal regulations and the increasing awareness of the protection of sensitive data, quality assurance and quality control, data management is becoming increasingly important and is an essential component of clinical studies.

Transparency of all work steps and high-quality processed data are crucial for reproducible and comprehensible results and statistical evaluations.

From collection to analysis - we ensure that your data is of the highest quality, reliable and trustworthy.

During a clinical trial, a lot of information is collected that needs to be structured in order to enable precise, scientifically sound analysis. Using state-of-the-art software and online technology, we achieve the ultimate goal of data management: data quality.

Based on our experience and tried-and-tested procedures as well as our commitment as a member of the Society of Clinical Data Management (SCDM), we guarantee fast and secure handling of sensitive data in all cycles.

Fast adaption and flexibility

Thanks to our completely internal data management team, we are not dependent on third parties for any processes – from initial creation to subsequent adjustments. You benefit from our efficient organizational processes right from the planning phase. The design and programming of eCRFs, the creation of annotated CRFs, the development of the database structure and the programming of customized data input masks and automated edit checks are all carried out directly by our experienced team. Change requests can be implemented, validated and documented immediately. This flexibility enables us to meet new requirements at short notice during ongoing studies without jeopardizing quality or schedules.

Quality assurance

In addition, we guarantee controlled quality assurance through systematic query management and manual data checks to ensure a valid and reliable database. Our fully documented processes guarantee seamless traceability and transparency. This keeps your projects flexible, efficient and always .

Coding

We also offer the transfer of medical and pharmaceutical coding, e.g. according to MedDRA, WHO-DD and ATC classification. Our experienced data managers and coders ensure that the coding is consistent, compliant and carried out with the utmost care.

Transfer of external data

If required, we integrate external data sources such as laboratory values or central measurement data into the study database. We pay attention to standardized data formats, plausibility checks and a precise link to the associated CRF data. This results in a complete, consistent and analyzable database that meets the highest quality standards.

Blind Data Reviews (BDR)

Prior to the statistical analysis, we carry out experienced blind data reviews (BDR). In close coordination with biostatistics, medical monitoring and the sponsor, we systematically check all study data for completeness, consistency and protocol compliance – while of course maintaining the blinding. Critical endpoints, medically relevant anomalies and potential data problems are identified, documented and specifically addressed before the lock. Through this structured and documented review process, we ensure that the final data analysis can be carried out on a qualitatively flawless and regulatory robust database.

Comprehensive data visualization and evaluation

Via the EDC application, we offer both classic status reports and reports created individually according to your requirements. The use of validated electronic systems with double-checked input ensures data integrity.

These include, for example:

Recruitment status and progress since the start of the study
Demographic data
(Serious) adverse events and other safety-relevant data
Study population overview
Review status
Missing data

We program reports tailored to your needs and integrate them into the EDC application. This allows us to create tables and graphics according to your wishes in order to create ideal interfaces to your processes.