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CLINICAL TRIAL MANAGEMENT

Clinical Data Management

Accurate and complete data is essential for the success of any clinical trial. We use state-of-the-art data management systems and rely on experienced professionals to ensure the accuracy, completeness, and integrity of clinical trial data. This facilitates efficient data collection, analysis, and reporting.

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Our data management team is adept at handling large volumes of data, ensuring that it is organized and easily accessible for analysis. Their expertise helps to streamline the process, reducing the time and effort required to reach conclusions and submit findings to regulatory bodies.

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Comprehensive clinical research organization

Clinical Management Services:

Our clinical data management services are designed to ensure the highest standards of data quality and integrity, supporting the success of your clinical trials from start to finish. Clinical data management services include:

Study Design and Database Setup

  • Collaborating with study teams to design efficient and effective data collection strategies.
     

  • Developing and configuring clinical trial databases using industry-standard platforms 
     

  • Creating case report forms (CRFs) and electronic data capture (EDC) systems tailored to study requirements.

Query Management

  • Generating and resolving data queries in collaboration with site staff.
     

  • Ensuring timely query resolution to maintain data integrity.
     

  • Documenting all query activities for audit trails.

Data Collection and Entry

  • Implementing electronic data capture (EDC) systems for streamlined data collection.
     

  • Training site staff on data entry procedures and system use.
     

  • Ensuring timely and accurate data entry into the clinical database.

Database Maintenance and Updates

  • Regularly updating the clinical database to incorporate protocol amendments and new requirements.
     

  • Conducting routine database maintenance to ensure optimal performance.
     

  • Implementing changes while maintaining data integrity and compliance.

Data Cleaning and Validation

  • Performing data cleaning activities to ensure data quality and consistency.
     

  • Conducting data validation checks to identify and resolve discrepancies.
     

  • Utilizing automated and manual review processes to maintain data accuracy.

Adverse Event and Safety Data Management

  • Managing the collection and reporting of adverse events (AEs) and serious adverse events (SAEs).
     

  • Ensuring accurate and timely recording of safety data.
     

  • Coordinating with pharmacovigilance teams to support safety monitoring.

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Comprehensive clinical research organization
Comprehensive clinical research organization

Data Integration and Standardization

  • Integrating data from various sources, including EDC, laboratory, imaging, and wearable devices.
     

  • Standardizing data according to CDISC standards (e.g., CDASH, SDTM, ADaM).
     

  • Ensuring consistent and harmonized data across all study datasets.

Data Lock and Archiving

  • Preparing for database lock with thorough data review and cleaning.
     

  • Conducting final quality checks and resolving outstanding issues.
     

  • Archiving study data in compliance with regulatory requirements.

Compliance and Quality Assurance

  • Ensuring adherence to Good Clinical Data Management Practices (GCDMP).
     

  • Conducting regular quality assurance checks and audits.
     

  • Maintaining comprehensive documentation for regulatory compliance.

Training and Support

  • Providing training for site staff and study teams on data management processes and systems.
     

  • Offering ongoing support to address data management challenges.
     

  • Ensuring continuous improvement through feedback and best practices.

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