Contact us
Services

Clinical Data Management

Clinical Data Management (CDM) is a vital part of the clinical trial process, responsible for ensuring that all data collected is accurate, complete, and compliant with regulatory standards. At VAICS, our CDM services are designed to manage the entire lifecycle of clinical data, from study start-up to database lock and submission. With a focus on quality, efficiency, and compliance, we leverage advanced technologies and best practices to provide end-to-end data management solutions that support successful clinical trials.

Our key services

Take a quick look at all of our clinical data management services.

Study start-up and CRF design

Know more

Database design and validation

Know more

Data entry and verification

Know more

Data cleaning and quality assurance

Know more

Data lock and database close

Know more

Coding and dictionary management

Know more

Regulatory submission support

Know more

Archival and
data retention

Know more

Study start-up and CRF design

The foundation of successful clinical data management begins with the design of Case Report Forms (CRFs). At VAICS, we work closely with sponsors during the study start-up phase to develop CRFs that are tailored to the specific needs of the trial. Our CRF design process focuses on:

Protocol review and CRF development

Reviewing the clinical protocol to ensure that all necessary data points are captured accurately and efficiently.

eCRF design for EDC systems

Designing electronic CRFs (eCRFs) that are user-friendly and optimized for Electronic Data Capture (EDC) systems, reducing data entry errors and improving data integrity.

CRF
annotation

Annotating CRFs to map each data field to the corresponding database variable, ensuring a smooth data flow from collection to analysis.

Data collection strategy

Developing a robust data collection strategy that aligns with the study's objectives, ensuring that the right data is captured at the right time.

Database design and validation

A well-designed database is critical for managing clinical trial data effectively. VAICS offers comprehensive database design and validation services to ensure that your trial data is stored securely and efficiently:

Custom database development

Building databases tailored to the specific requirements of your clinical trial, incorporating all necessary data fields, validation checks, and quality control measures.

EDC system integration

Integrating the database with EDC systems to facilitate real-time data capture and ensure seamless data flow.

Validation and testing

Conducting rigorous validation and testing of the database to ensure that it meets all regulatory requirements and is capable of handling the data volume and complexity of the trial.

Data migration support

Providing support for data migration from legacy systems to new platforms, ensuring data integrity and consistency during the transition.

Data entry and verification

Double data entry

Utilizing a double data entry process where two independent entries are compared to identify and correct discrepancies, ensuring the highest level of data accuracy.

Real-time data entry

Supporting real-time data entry in EDC systems, enabling immediate access to data and facilitating timely monitoring and analysis.

Automated data verification

Implementing automated verification checks to detect and flag data inconsistencies or errors as they occur, minimizing the need for post-entry corrections.

Manual data review

Conducting manual reviews of critical data points to ensure that all entries are accurate and complete before database lock.

Data cleaning and Quality Assurance

Edit check programming

Developing and implementing edit checks that automatically flag data discrepancies, missing values, and outliers for review and resolution.

Query management

Generating, tracking, and resolving data queries in a systematic manner to ensure that all data discrepancies are addressed promptly and accurately.

Discrepancy resolution

Working closely with study sites to resolve any discrepancies in the data, ensuring that the final dataset is accurate and consistent.

Ongoing data monitoring

Continuously monitoring the data to identify and address any quality issues as they arise, ensuring that the data remains clean and reliable throughout the trial.

Final data review

Conducting a thorough review of the cleaned data before database lock to ensure that all queries have been resolved and the data is ready for analysis.

Data lock and Database Close

Pre-lock data review

Conducting a comprehensive review of the data prior to locking the database, ensuring that all queries have been resolved, and the data is accurate and complete.

Database lock procedure

Implementing a formal database lock procedure that prevents any further modifications to the data, ensuring that the locked database reflects the completed clinical trial data.

Database close-out

Finalizing all database activities, including the generation of audit trails, data backups, and preparation of the database for archival.

Audit readiness

Ensuring that the locked database is fully documented and ready for audit by regulatory authorities, with all data and processes traceable and compliant.

Coding and Dictionary Management

Medical coding with MedDRA and WHO drug

Coding adverse events, medications, and other medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) and WHO Drug Dictionary to ensure consistency and accuracy in the data.

Coding guidelines compliance

Ensuring that all coding is performed in accordance with established guidelines and standards, maintaining consistency across the dataset.

Dictionary management

Managing and updating coding dictionaries to reflect the latest standards and ensuring that the coding remains consistent throughout the trial.

Coding review and reconciliation

Reviewing coded data for accuracy and performing reconciliation to resolve any discrepancies, ensuring that the final coded dataset is ready for analysis and submission.

Regulatory submission support

Submission-ready datasets

Preparing datasets in the required format for submission to regulatory authorities such as the FDA, EMA, or other global agencies.

Documentation preparation

Generating all necessary documentation to accompany the submission, including study reports, statistical analysis plans, and data definition files.

Regulatory compliance

Ensuring that all submitted data and documentation meet the regulatory guidelines and standards for clinical trial submissions.

Electronic submission (eCTD)

Supporting electronic submission of clinical trial data through the Electronic Common Technical Document (eCTD) format, facilitating efficient review by regulatory agencies.

Archival and data retention

Secure data archival

Storing clinical trial data in a secure, compliant manner, with robust security measures in place to protect against data loss or unauthorized access.

Compliance with regulatory requirements

Ensuring that data is archived in accordance with regulatory requirements, including retention periods and access controls.

Data retrieval and access

Providing easy access to archived data for future use, whether for regulatory submissions, audits, or secondary analysis.

Archival documentation

Maintaining detailed documentation of the archival process, including data storage locations, access controls, and retention schedules.

Why choose VAICS for Clinical Data Management?

VAICS offers a comprehensive suite of Clinical Data Management services designed to support every stage of your clinical trial. Our commitment to accuracy, quality, and compliance ensures that your trial data is managed with the highest standards of excellence. By leveraging cutting-edge technologies and a team of experienced professionals, VAICS delivers reliable, efficient, and compliant data management solutions that drive successful clinical trials and support your regulatory submission needs.

Contact Us