Clinical Data Management

The Clinical Data Management (CDM) team is involved in all aspects of clinical trial process, from CRF/eCRF development till DB closure. At Clinnex we have implemented industry recognized and accepted data management systems, which enables us to deliver high-quality outputs with confidence.

The CDM team has extensive data management experience across a broad range of therapeutic areas, using both EDC and paper systems. The CDM team applies quality norms and procedures to complete complex clinical programs successfully. Experienced and trained resources at Clinnex ensure that each study is accomplished using most efficient technologies available.

Clinical Data Management (CDM) is a critical component of the clinical research process that involves the collection, cleaning, validation, and management of data obtained from clinical trials. Here’s a detailed description of our Data Management process which adopts the Risk based approach to save time and cost for the overall conduct of the study:

Data Collection

CDM begins with the collection of clinical trial data from various sources, including study sites, laboratories, imaging facilities, and electronic data capture (EDC) systems. Data can include information on patient demographics, medical history, study interventions, adverse events, and efficacy outcomes.

Data Cleaning

After data entry, the data undergoes a comprehensive cleaning process to identify and resolve any errors, inconsistencies, or missing values. Data cleaning activities may involve query generation, data review, and resolution of discrepancies with study sites or investigators. The goal is to ensure that the data is of high quality and meets regulatory standards for accuracy and reliability.

Database Management

CDM involves the management of the clinical trial database, including database setup, maintenance, and security. Database management activities include database design, user access control, version control, and backup procedures to ensure data integrity and confidentiality throughout the trial.

Quality Control

CDM incorporates quality control measures to monitor the quality and compliance of data management processes. Quality control activities may include regular data reviews, audit trails, and quality assurance checks to identify and address any issues or deviations from standard operating procedures.

Regulatory Compliance

CDM ensures compliance with regulatory requirements and guidelines, including Good Clinical Practice (GCP) and regulatory standards such as 21 CFR Part 11 and ICH E6 (R2). Compliance activities may include documentation of data management procedures, audit readiness, and participation in regulatory inspections.

Data Reporting

CDM plays a crucial role in data reporting and analysis for clinical trial outcomes. Data management teams generate clinical study reports, statistical analysis plans, and data listings for regulatory submissions and scientific publications. They also collaborate with biostatisticians and clinical researchers to conduct data analyses and interpret study results.

Some of the key components that we include in our process to adopt the risk-based approach to Data Management are:

Risk Monitoring and Reporting
Risk Mitigation Strategies
Risk Assessment
Risk Identification
Documentation and Communication
Contingency Planning

The Data Management Services Offered by Clinnex include:

CRF Design

Database Design (eCRF/Paper)

DM/SAS Programming

Data Entry (Blinded)

Data Validation

Clinical Data Coding

External Data Handling (i.e. Central Lab. etc.)

SAE Reconciliation

Medical Review

Protocol Violations

Database Closure

Data Mapping (CDISC)

We offer highly specialised clinical research services.

Apart from our main line of services, we are open to discussion on proposals for customized services for our clients.

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