Clinical Data Management Services

At DataPro Solutions, LLC, we offer comprehensive end-to-end solutions for your clinical data management needs. Our dedicated team, equipped with indication-specific expertise, ensures seamless support throughout your project. Discover how our system can enhance your clinical trial experience.

Clinical Database Management Start-Up

Customized Planning:Tailoring a data management plan that aligns with your protocol, study site demands, and unique needs.
Optimal EDC Selection: Utilizing the best Electronic Data Capture (EDC) systems to meet your project's requirements.
CRF Design & Guidelines: Crafting Case Report Forms (CRFs), accompanied by detailed guidelines for consistency and clarity.
Efficient Data Coordination: Streamlining the flow of information right from the onset.

Clinical Database Development

Database Building and Screening: Establishing robust databases with meticulous testing and quality control (QC).
User Acceptance Training (UAT): Collaborating with sponsors and study sites for comprehensive UAT.

User Administration

Account Setup: Efficiently creating and managing user accounts.
Comprehensive Training: Providing in-depth training for all users to ensure proficiency.

Clinical Database Conduct

Data Cleaning & Query Resolution: Ensuring data accuracy and resolving discrepancies.
Medical Coding & External Data Integration: Streamlining medical coding and integrating external vendor data.
Safety Event Reconciliation: Diligently reconciling serious adverse events (SAE).
Continuous Metrics & Reporting: Offering ongoing EDC metrics and detailed 'Clean Submit' reports.

eCRF Design and Protocol Adherence

Protocol-Compliant eCRF Design: We ensure that the electronic Case Report Form (eCRF) design strictly adheres to the Clinical Study Protocol, maintaining integrity and accuracy in data capture.

Analysis Population Definitions

Comprehensive Population Categories: We assist in defining various analysis populations, including Intent-to-Treat (ITT), safety, per-protocol (PP), pharmacokinetics (PK), and pharmacodynamics (PD).
Subgroup Analysis: Tailored analysis for specific subgroups, such as tumor type, to facilitate more detailed and relevant findings.

Statistical Programming and Analysis

Baseline Definitions: Our team aids in establishing baseline definitions for programming, ensuring consistency and clarity in data analysis.
Response Criteria and Adverse Event Analysis: We contribute to determining response criteria and analyzing adverse events, providing crucial insights into drug safety and efficacy.
Clinically Significant Laboratory Analysis: Focusing on critical analyses like the Common Terminology Criteria for Adverse Events (CTCAE) version 5.

Licensing and Dictionary Selection

Licensing Facilitation: We assist sponsors in obtaining licenses for WHODRUG and MedDRA dictionaries. If your company does not hold these licenses, we will guide you through the process of securing them, ensuring you have the necessary tools for effective coding in your clinical trial.

Tailored Dictionary Recommendations: Each clinical trial has its unique needs. We provide expert recommendations on whether to use the current version of WHODRUG or MedDRA throughout your entire program or for a specific study, optimizing the coding process for accuracy and efficiency.

Collaborative Coding Strategy

Licensing and Dictionary Selection

Integration with Medical and Regulatory Teams: We work closely with your Medical Monitor and Regulatory teams to ensure that the most appropriate terms are selected for coding. This collaboration is vital for maintaining the integrity and relevance of data throughout the study.

Customized eCRF Panels: Our team advises on which panels within the electronic Case Report Forms (eCRFs) should be coded, tailoring our approach to meet the specific needs of your study.

Adaptation to Unique Organizational Terminology: We recognize that some organizations have developed their unique synonyms for coding terms. DataPro Solutions is adept at integrating these organization-specific terms with the standard terminology of WHODRUG and MedDRA, ensuring a seamless blend of custom and standardized coding practices.

The Importance of Precise Coding

Licensing and Dictionary Selection

The Importance of Precise Coding

Enhancing Data Quality: Accurate coding is essential for the analysis, interpretation, and reporting of clinical trial data. It aids in the clear identification of adverse events, drug interactions, and other critical aspects of drug safety and efficacy.

Regulatory Compliance: Proper use of WHODRUG and MedDRA dictionaries ensures compliance with international regulatory standards, which is crucial for the approval and marketing of new drugs.

Facilitating Global Communication: Standardized coding allows for consistent data interpretation across different countries and regulatory environments, facilitating global collaboration and data sharing.

Clinical Data Management Consulting

Clinical Data Management Services

Clinical Database Management Start-Up

Clinical Database Development

User Administration

Clinical Database Conduct

Clinical Database Lock

Biostatistical Services Collaboration

eCRF Design and Protocol Adherence

Analysis Population Definitions

Statistical Programming and Analysis

Review and Validation

CDISC Controlled Terminology and Tools

WHODRUG and MedDRA Dictionaries: Expert Coding Services

Licensing and Dictionary Selection

Licensing and Dictionary Selection

Licensing and Dictionary Selection

Collaborative Coding Strategy

Licensing and Dictionary Selection

Licensing and Dictionary Selection

The Importance of Precise Coding

Licensing and Dictionary Selection

The Importance of Precise Coding

Clinical Data Management Consulting

Clinical Data Management Services

Clinical Database Management Start-Up

Clinical Database Development

User Administration

Clinical Database Conduct

Clinical Database Lock

Biostatistical Services Collaboration

eCRF Design and Protocol Adherence

Analysis Population Definitions

Statistical Programming and Analysis

Review and Validation

CDISC Controlled Terminology and Tools

WHODRUG and MedDRA Dictionaries: Expert Coding Services

Licensing and Dictionary Selection

Licensing and Dictionary Selection

Licensing and Dictionary Selection

Collaborative Coding Strategy

Licensing and Dictionary Selection

Licensing and Dictionary Selection

The Importance of Precise Coding

Licensing and Dictionary Selection

The Importance of Precise Coding

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