Clinical trial data management services

Elevating clinical trial data management with smart solutions

A single trial can produce over 3 million data points

Only 20% of clinical trial data is integrated across different systems

Big data analytics and artificial intelligence are projected to reduce trial costs by up to 15%

Clinical data managers spend 30% of their time on data reconciliation

Digital transformation of clinical data management for accuracy, speed and efficiency

Our Services 

We offer comprehensive clinical trial data management services tailored to meet the evolving needs of the life sciences industry. Our dedicated team of experts is committed to ensuring the accuracy, integrity, and efficiency of your clinical trial data throughout the study lifecycle.

Study database design and development

Our team is also proficient in deploying state-of-the-art Electronic Data Capture (EDC) systems that facilitate the collection, management, and storage of clinical trial data. We also assist in developing user-friendly electronic case report forms (eCRFs) that streamline data entry and reduce errors.

We collaborate with sponsors and study teams to design and develop customized databases tailored to specific clinical trial requirements, ensuring they are robust, scalable, secure, and in compliance with regulatory standards. Our team also undertakes data modeling creating logical and physical data models that accurately represent the clinical data’s structure and relationships.

Data collection and entry

Our team oversees the collection and entry of clinical trial data from various sources, including electronic case report forms (eCRFs), patient diaries, laboratory reports, and medical records. Our team ensures the data is entered accurately, consistently, and in a timely manner, minimizing errors and discrepancies.

We also make sure the decision makers get a unified view of the data by integrating disparate data sources, such as laboratory information management systems (LIMS), electronic health records (EHR), and other clinical systems, into a unified database. Our team is also capable of developing APIs and middleware solutions to enable seamless data exchange between systems.

Data cleaning and quality control

We conduct comprehensive data cleaning activities to identify and resolve discrepancies, inconsistencies, and missing data points in the study database. Our team develops automated notification processes which can trigger alerts to the stakeholders of any inconsistencies or errors in the data.

i2e is an expert in implementing rigorous quality control processes to ensure the cleaned data meets the highest standards of accuracy and integrity. We establish comprehensive validation rules and checks to ensure data meets predefined criteria for accuracy and completeness. Our data experts can develop dashboards that provide real-time visualizations of data quality indicators, allowing for quick identification and ensuring transparency and accountability.

Database maintenance and administration

We provide ongoing maintenance and administration of the study database throughout the trial lifecycle, including user access management, version control, and database backup and recovery. Our data experts perform regular maintenance tasks such as indexing, defragmentation, and updating statistics to ensure optimal database performance. They will also Implement comprehensive backup and recovery strategies to protect data against loss and to ensure quick data recovery.

Our team carries expertise in Implementing robust security measures such as encryption, firewall configurations, and intrusion detection systems to protect sensitive clinical data.
i2e’s expert data scientists ensure the database remains operational and compliant with regulatory requirements and industry standards.

Data reconciliation and integration

i2e reconciles clinical trial data across multiple sources, including investigational sites, central laboratories, and electronic health records by developing and integrating APIs to facilitate seamless data exchange.

Our team is proficient in designing and implementing Extract, Transform, Load (ETL) processes to consolidate data from various sources into a central database. They will also establish data governance frameworks to manage the quality, availability, and security of the trial data.

Data transfer and archiving

We manage the secure transfer of clinical trial data between stakeholders, including sponsors, CROs, and regulatory authorities, in compliance with data protection regulations. Our team can implement secure data transfer protocols (e.g., SFTP, HTTPS) to ensure data is transmitted securely between systems and locations. We can also develop automated data transfer workflows to streamline and schedule regular data transfers, reducing manual intervention and errors.

Our team ensures the trial data is archived securely and retained for the required period according to regulatory guidelines and sponsor requirements. Our team is also experienced in including comprehensive metadata with archived data to facilitate easy retrieval and understanding in the future. We can also guide and assist in deploying cloud-based solutions to enhance scalability, flexibility, and cost-efficiency of database management.

Database locking

Our data management experts will collaborate with the study statisticians and the clinical trial sponsors and ensure the data is complete, accurate and consistent. We are proficient in establishing robust protocols for locking databases at key stages of the clinical trial, after data collection is complete and before data analysis begins.

Our team can set up role-based access controls (RBAC) to restrict who can lock or unlock the database, ensuring that only authorized personnel can perform these actions. We also develop detailed audit trail mechanisms for all actions related to database locking and unlocking, providing transparency and accountability.

We also set up real-time monitoring systems to track the status of database locks and alert relevant personnel to any issues or unauthorized attempts to access locked data.

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