Clinical Data Management

Great data matters! In-depth understanding of data in clinical trial execution is crucial. Using effective data governance as a starting point, combined with the right data infrastructure and ecosystem is simply a success story, while poor data management will only leave you vulnerable. 

Clinical Trials designs and complexities vary, and every trial dataset is important. At GCP-Service, we provide data management services tailored to match your project needs. We believe that high quality clinical data management is an important reflection of fast and successful clinical trial execution.

Our expertise in intelligent understanding of data ensures:

  • Full focus on data in clinical trials
  • We are able to develop trust and long-lasting partnerships with our clients
  • We are able to meet 100% of eCRFs releases and DB locks deadlines

Showing the power of teamwork through expert coordination across the departments. We envision our company as a provider of small and effective teams with a valuable experienced partner.  

Our highly skilled and highly educated Data Management team uses innovative and flexible electronic data capture (EDC) systems coupled with related processes to ensure data integrity and accountability.  

 

It is crucial to get it right from the beginning. That’s why our experienced team will support a successful data base set-up with our advanced technology to provide the perfect data base solution tailored to your trial needs

We understand the importance of a timely base lock in ensuring no manipulation of study data for final analysis and this is why we commit to support you throughout all the activities in data-base lock process and ensuring that all discrepancies are resolved.

Our systems, SOPs, and personnel are fully equipped to manage paper-based data capture as well as electronic data capture (EDC). This allows us to have customized, reliable, and cost-effective solutions for clinical data management (CDM) operations that are ready for use. 

We believe that the most effective and ideal way to efficiently clean and organise data is to integrate the study team in the early stages of data management, a process that we have perfected over the years.

Work with us for full-trial build or select from our many options of Data Management services:

  • Consultancy (strategic program planning, protocol review, EDC selection, EDC provider audits etc.) 
  • EDC and Paper Trial Set-Up & Management 
  • Experienced EDC Builders 
  • Access to Different EDC Solutions (from opensource solutions to high end systems etc.) 
  • Data Management Plan (DMP) Development 
  • Data Management Project Management 
  • CRF/eCRF Design, Development and Maintenance 
  • CRF Annotation & Review 
  • Database Build & Design 
  • Data Validation Specifications 
  • Edit Checks Programming & Testing 
  • Data Cleaning and Query Management 
  • Medical Coding using WHODrug & MedDRA Dictionaries 
  • Safety & Lab Data Reconciliation 
  • Data Export/Transfer 
  • Real-time Data Viewing and Reporting 
  • CDASH Compliant Deliverables 
  • CDISC SDTM Data Conversion service

Database Release in Four Weeks

Our team of experienced data managers are primed and ready to help you with the launch your study. 

By focusing and working together we can accomplish an eCRF release fast. A typical GCP-Service study build takes less then 4 weeks compared to the 12-week industry average. This means we pride in meeting your deadlines while maintaining the highest levels of data quality and integrity.

Progress updates throughout the course of the study and compliance with protocol amendments are also proactively managed. 

Get the most out of Remote Monitoring and Powerful Edit Checks

We can’t be everywhere at once, but we can track data from multiple locations in real time. We encourage our clients to use our data management, remote monitoring capabilities and our statistical monitoring to review, track, and clean data.

It is critical to have cleaned and high-quality data ready in time for submission, and we are ready to support you throughout the entire journey.

  

How GCP-Service Data Management works with EDC

  • Study launch in weeks rather than months 
  • Simplified data entry with edit checks and query automation 
  • Flexibility in seamless mid-study updates without downtime 
  • Tailored to the workflows of Pharmaceuticals, Medical devices, and Diagnostic companies 
  • Meets or exceeds all global data collection regulations 

 

GCPS DM partners

Using the best matching tool for your study plans is essential. We can provide you expertise and service with different EDC provider. Therefor GCP-Service partners with different providers to maximize productivity by easily capturing, processing, and integrating data from multiple sources on a compliant electronic data capture (EDC)