Data Management & Biostatistics

The foundation of clinical research is data. The quality and statistical soundness of data collected from clinical trials must be managed and retained, which calls for effective solutions. Our excellent and reasonably priced data management services make it possible to gather, standardise, clean, and analyse study data with accuracy.

Features

Study Build Activities

Develop studies Using the dynamic visit structures, workflows, version control, and calculated subject scheduling capabilities of our robust and adaptable Study setup module, you can do tasks more quickly and easily.

Plan for Data Management

Create and implement a thorough plan to manage your data effectively while following to the quality criteria that are specified in the ICH-GCP Guidelines.

SAE Reconciliation

Utilising our reliable data extraction techniques, we were able to get Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the research more quickly than ever. This saves you time and effort and enables rapid and effective reconciliation with safety listings.

Management of Lab Data

Upload lists of reference ranges for each laboratory test parameter with simplicity, and use data cleaning to guarantee that the system is recording correct lab result values that are within the acceptable range.

Programming and Validation

Using real-time edit checks built by our professional staff, be certain of the legitimacy and accuracy of Study data, whether basic or complicated. This feature’s design is based on systematised data validation standards that were developed following a thorough analysis of the study protocol.

Online Training

With our engaging Online Training Solution, which includes how-to videos, detailed instructions, and quizzes for a better learning experience, you can learn about our products whenever and wherever you want.

Personalised Database Design, Development, and Screen Testing

Use our configured databases, which we established based on needs particular to the study, and our methodical regression testing, which is carried out using carefully written test scripts, to verify the integrity of the data.

Quality Control and Quality Assurance

From the beginning to the end of the Study, benefit from high-quality processes because our best practises are guided by clear standards.

Guidelines for CRF Design and Data Entry

Get your eCRFs created by our team of specialists, along with a Customer-Specific CRF Library and a guide on how to enter study-specific data into eCRFs, to efficiently gather study data.

Locking databases, exporting data, and archiving data

Using our solutions, such as data exports (.csv and.xls formats) and database locks, you may locate data errors and guarantee a clean and complete database for final analysis. Consistent reviews and our sophisticated discrepancy manager module can accomplish this.

DC & Biostat Services Brochure

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