Data Management

Ensure reliable and reproducible results through high data quality

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The aim of clinical data management in clinical trials is to ensure accurate, complete and plausible study data by implementing data acquisition and data processing processes. As study data contribute significantly to the success of subsequent biometric analyses or clinical trials (for example by minimizing data loss), it is an integral part of clinical research. Particularly due to increasing quality and ethical requirements as well as stricter requirements of authorities, study registers and scientific journals, the structured handling of study data in the medical device sector is becoming more and more important.

Basically, clinical data management includes automatic plausibility and completeness checks, as well as predefined process logs (e.g. manual control by a data manager at specific points of time). In particular for critical times (e.g. before the database is closed), implemented standard instructions (SOPs) ensure that processes can be carried out as uniformly as possible to minimize the amount of errors. By using a tailor-made data query management for clarifying data entry discrepancies, clearly predefined storage and data structures, standardized data collections and appropriate study documents, future data evaluations can be realized in a targeted, cost and time-efficient manner.

In addition to the reduction of the data loss risk, early involvement of the sponsor in the clinical data management processes (e.g. prior to the studies) may also increase the safety of study participants. Thus, by adapting the reconciliation plan (e.g. by taking into account customary processes) the risk of complications or serious events (e.g. due to medication errors) within a clinical trial can be minimized. Study-specific data management and appropriate study documents can increase the acceptance of the study results by authorities or scientific journals and thus complete the portfolio of clinical data management.

Beside the customer-specific planning and validation of electronic Case Report Forms (eCRFs), CCMD also offers technical support for data management throughout the entire study period.  By means of continuous pre-study on-site and online trainings in data management and eCRFs, CCMD enables you to build valuable core competencies in these areas to ensure the maximum possible data quality of your study. Our additional support in document development enables you to handle study processes in a time and cost-efficient manner.

In the field of data management our service range includes:

  • Training of on-site personnel (on-site and online)
  • Development of eCRF completion guidelines
  • Development of a study specific data management plan in agreement with the client
  • Automatic checks for plausibility and completeness (implemented into the eCRF)
  • Regular manual data review in agreement with the client
  • Query management for clarification of implausible data entries and discrepancies
  • Adverse event (AE) and serious adverse event (SAE) reconciliation
  • Development of AE and SAE reconciliation plans