Clinical Data Management

Collaborate with RCS for Superior Clinical Data Management

Choosing RCS for your Clinical Data Management needs ensures that your clinical trial will be completed on schedule, with the utmost accuracy in data collection. We harness cutting-edge technology platforms, including customized electronic data capture (EDC) systems, tailored to fit your requirements and adaptable to decentralized or virtual trial models.

Our services provide a full spectrum of Clinical Data Management, from swift database setup to seamless integration of clinical data sources, expert medical coding, efficient query management and resolution, proficient handling of external vendor data, and secure database lock, culminating in the delivery of clean, high-quality clinical trial data.

As specialists in data management, RCS dedicates comprehensive attention and expertise to every phase of data collection and management strategy. Our commitment to data excellence ensures reliable service delivery and the establishment of enduring partnerships with our clients.

• 20 years of experience, and qualified domain experts

• In-house Electronic Data Capture (EDC) System

• Cloud-Based Suite (AWS)

• Integrated Suite (CDMS, ePRO, CTMS)

• Standardized coding and reporting MedDRA & WHODrug Dictionary

Our expertise ensures your clinical trial data is accurate, compliant, and ready for analysis

• Medidata Rave

• Oracle Clinical

• Inform

• Open Clinica

With 20 years of experience in clinical trial management, we have developed deep expertise in leveraging leading Electronic Data Capture (EDC) systems to optimize clinical research. Our proficiency spans across industry-standard platforms, including Medidata Rave, Oracle Clinical, Inform, and Open Clinica. This diverse experience enables us to tailor our data management strategies to the specific needs of each trial, ensuring efficient, accurate, and compliant data collection and management.

Our team’s comprehensive knowledge of these systems ensures seamless integration into any clinical study, providing robust support for complex trial requirements and contributing to the overall success of our clients' research programs.

At RCS, we don't just manage projects; we craft experiences

Our end-to-end standardised process and tools pave the way for exceptional service

EDC Systems

Clinical Data Management Services

CRF Designing and Development

Utilizing our in-house EDC system, we design and develop CRFs that are highly customizable and tailored to the specific needs of each study. Our 20 years of experience ensures that data capture is precise and aligns perfectly with study objectives

Clinical Data Management Plan

Our DMPs are crafted by qualified domain experts, leveraging two decades of expertise to ensure a comprehensive and compliant data management strategy. This plan is integrated with our cloud-based suite for seamless execution.

Clinical Database Development

We develop secure and robust clinical databases using industry-leading platforms such as Medidata Rave, Oracle Clinical, and Inform. Our databases are designed to support seamless data capture and management, tailored to meet the specific requirements of each study.

UAT of Screen and Edit Checks

We perform comprehensive UAT to rigorously test the screens and edit checks within our clinical databases, ensuring they function correctly and efficiently before deployment. This step is crucial for preventing data entry errors and ensuring data integrity.

Discrepancy Management and Data Review

Our in-house EDC system facilitates efficient discrepancy management and data review, supported by automated alerts and real-time reporting. This process is streamlined through integrated tools such as Open Clinica, ensuring timely resolution of data issues.

Medical coding

We employ standardized coding practices using MedDRA and WHODrug Dictionary, supported by advanced systems like Oracle Clinical and Medidata Rave. Our coding ensures consistency and accuracy in adverse event and medication data across all trials.

Data reconciliation

Our domain experts conduct thorough SAE and lab data reconciliation, using integrated systems to cross-verify data with the clinical database. This ensures that all discrepancies are addressed and resolved efficiently, maintaining data integrity.

      Data Quality control

Our data QC processes are underpinned by 20 years of expertise, utilizing tools like Inform and our in-house EDC system to monitor and maintain high data quality throughout the study lifecycle.

Customized Study reports

We generate detailed and customized study reports, including data entry progress, discrepancy management, and SDV, using our integrated suite. These reports provide clear, actionable insights to stakeholders.

                              Database lock

We securely lock the clinical database at the study's conclusion, ensuring that all data is finalized and protected from any further changes. This process guarantees data integrity and is conducted in strict adherence to regulatory standards.

Database Maintenance and Archival

we facilitate the seamless transfer of the finalized data to sponsors or regulatory bodies. Our transfer process ensures that all data is delivered securely, accurately, and in the required format.

Database Transfer

Following the database lock, we facilitate the seamless transfer of the finalized data to sponsors or regulatory bodies. Our transfer process ensures that all data is delivered securely, accurately, and in the required format.

At RCS We turn complexity into clarity

From collection to analysis, we manage your entire clinical data with meticulous attention to detail, ensuring the highest quality outcomes