Clinical data management services
With a team of experienced data managers, we offer customized solutions tailored to the specific needs of your study, including protocol adherence, regulatory compliance, and data cleaning processes. Our system supports real-time data capture, allowing you to monitor study progress and resolve discrepancies as they arise, ensuring the integrity of your data at all times. Additionally, our platform integrates advanced reporting and analytics tools, enabling you to analyse data and generate insights that drive informed decision-making and improve study outcomes.
By leveraging cutting-edge technology and adhering to industry standards such as CDISC, GCP, and ICH guidelines, we ensure that your clinical trial data is not only accurate but also compliant with regulatory requirements. Whether you’re conducting a small pilot study or a large multi-site trial, our Clinical Data Management services are designed to optimize data flow, streamline operations, and reduce the time to study completion, helping you achieve reliable and actionable results efficiently.
End-to-End Clinical Data Management (CDM) Process
Our platform offers a comprehensive, end-to-end CDM process that covers all phases of clinical trials, ensuring that your data is managed with precision, accuracy, and regulatory compliance. Our streamlined approach integrates the latest technology with industry best practices, offering you a seamless experience from study setup through study conduct and close-out.
Study Setup
The foundation of a successful clinical trial begins with meticulous study setup. During this phase, we focus on creating a robust framework for data capture and management.
Database Design (CRF Design)
We collaborate with your team to design a database that aligns perfectly with your study protocol. This involves creating electronic case report forms (eCRFs) that capture all required data points, ensuring that the design supports seamless data collection and high data quality.
eCRF Specifications
Each eCRF is custom-built based on your study needs, ensuring that it captures precise and protocol-specific data. Specifications include detailed field definitions, data types, and conditional logic to ensure that data is accurately recorded.
Edit Check Specifications
To maintain data accuracy and consistency, we develop edit check specifications that automatically flag potential data discrepancies. These real-time validation rules help to identify and correct errors as they occur.
User Acceptance Testing (UAT)
Before launching the trial, we conduct rigorous User Acceptance Testing to ensure the database and eCRFs function as intended. This process ensures that all system features, validation checks, and data flows are thoroughly tested and approved before going live
Data Management Plan (DMP)
A comprehensive Data Management Plan is developed, outlining key data management procedures, including data collection, cleaning, validation, and reporting processes. This document serves as a guide for ensuring data quality throughout the study.
CRF Completion Guidelines
Clear CRF completion guidelines are provided to study staff and investigators, ensuring consistent and accurate data entry across all study sites. This step minimizes variability in data capture, ensuring uniformity.
Serious Adverse Event (SAE) Reconciliation Plan
We develop an SAE reconciliation plan to ensure that all serious adverse events reported in the safety database are consistent with the data captured in the EDC system. This plan outlines procedures for cross-referencing and resolving discrepancies between the clinical and safety databases
3rd Party Integrations
Our platform seamlessly integrates with third-party systems, such as safety databases, central labs, and other specialized software. These integrations ensure smooth data transfer and synchronization between different platforms, supporting comprehensive data analysis and reporting.
Study Conduct
Once the study is live, our platform facilitates seamless data management, ensuring that all data is captured, validated, and monitored in real-time.
Data Validation
Continuous data validation checks are conducted throughout the study to ensure data accuracy and compliance with predefined validation rules. Automated checks help identify discrepancies, missing data, and out-of-range values early on, allowing for timely corrections.
Discrepancy Management
Our platform includes a robust discrepancy management system, allowing study teams to resolve data discrepancies as they arise. Investigators and site staff are promptly alerted to any inconsistencies, ensuring efficient resolution and maintaining data integrity.
Vendor Reconciliation
If your study involves third-party vendors for services such as laboratory data or imaging, we facilitate vendor reconciliation to ensure all external data is accurately incorporated into the clinical database. This ensures that data from different sources is harmonized and compliant with regulatory standards.
Locking/Freezing
To preserve data integrity during interim analyses or at the end of the study, our system allows for data freezing and database locking. This feature prevents further changes to the dataset, ensuring that the data is secure and ready for analysis or regulatory submission.
Medical Coding
To standardize terminology and facilitate regulatory submissions, we provide medical coding services using dictionaries such as MedDRA and WHO Drug. This process ensures that adverse events, medications, and medical history are coded uniformly, allowing for consistent data interpretation.
Source Data Verification (SDV)
Our platform supports Source Data Verification (SDV), ensuring that data entered into the EDC system matches the original source documents. This process is critical for maintaining data accuracy and compliance with Good Clinical Practice (GCP) guidelines.
Study Close-Out
Once the study is live, our platform facilitates seamless data management, ensuring that all data is captured, validated, and monitored in real-time.
Database Lock
Once all data is finalized, and all discrepancies are resolved, the database is locked to prevent any further changes. This final step ensures that the data set is ready for statistical analysis and regulatory submission.
Trial Master File (TMF)
We maintain a complete and compliant Trial Master File (TMF), ensuring that all essential documents are captured, organized, and readily accessible for audit or regulatory review. This ensures that all study documentation is available for regulatory submission and inspection, meeting industry standards.
Our End-to-End Clinical Data Management services are designed to simplify and optimize the entire clinical trial process, ensuring high-quality data collection, timely delivery, and full regulatory compliance. Whether you’re conducting a small-scale trial or a large, multi-site study, our platform provides the tools and expertise to ensure the success of your clinical research.